lead_sponsor: Sanofi

summary:
Primary Objective:

To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.

Secondary Objective:

To compare the overall survival in both treatment arms.
To evaluate the objective response rate in both treatment arms.
To evaluate the duration of response in both treatment arms.
To evaluate the clinical benefit rate in both treatment arms.
To evaluate progression-free survival on next line of therapy.
To evaluate the pharmacokinetics of amcenestrant, and palbociclib.
To evaluate health-related quality of life in both treatment arms.
To evaluate the time to first chemotherapy in both treatment arms.
To evaluate safety in both treatment arms.

ReferenceType: derived

ReferenceCitation: Bardia A, Cortes J, Hurvitz SA, Delaloge S, Iwata H, Shao ZM, Kanagavel D, Cohen P, Liu Q, Cartot-Cotton S, Pelekanou V, O'Shaughnessy J. AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib versus letrozole plus palbociclib for previously untreated ER+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2022 Mar 15;14:17588359221083956. doi: 10.1177/17588359221083956. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via OAI-PMH title and first author match)

host_type: repository

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: SAGE Publications

location_facility:
Investigational Site Number :0360004
Investigational Site Number :0360001
Investigational Site Number :0360005
Investigational Site Number :1520001
Investigational Site Number :1560024
Investigational Site Number :8260002
Investigational Site Number :1000008
Investigational Site Number :1560028
Investigational Site Number :1560022
Investigational Site Number :2680002
Investigational Site Number :1520003
Investigational Site Number :2500005
Investigational Site Number :8400009
Investigational Site Number :6430010
Investigational Site Number :8400076
Investigational Site Number :8400006
Investigational Site Number :7240001
Investigational Site Number :7920002
Investigational Site Number :4100003
Investigational Site Number :8400055
Investigational Site Number :0760007
Investigational Site Number :2500010
Investigational Site Number :7240011
Investigational Site Number :4100002
Investigational Site Number :1560027
Investigational Site Number :2680003
Investigational Site Number :0320009
Investigational Site Number :8400016
Investigational Site Number :8400070
Investigational Site Number :1520004
Investigational Site Number :3920010
Investigational Site Number :1560017
Investigational Site Number :1520007
Investigational Site Number :1560044
Investigational Site Number :1560049
Investigational Site Number :7920013
Investigational Site Number :2680001
Investigational Site Number :8400058
Investigational Site Number :8400024
Investigational Site Number :7020001
Investigational Site Number :2680006
Investigational Site Number :8400061
Investigational Site Number :2680004
Investigational Site Number :0320006
Investigational Site Number :8400075
Investigational Site Number :1580001
Investigational Site Number :0760003
Investigational Site Number :3800002
Investigational Site Number :7240006
Investigational Site Number :8400038
Investigational Site Number :1560055
Investigational Site Number :8040004
Investigational Site Number :8400069
Investigational Site Number :0320008
Investigational Site Number :1560045
Investigational Site Number :8260005
Investigational Site Number :3480009
Investigational Site Number :7240003
Investigational Site Number :2760003
Investigational Site Number :7240008
Investigational Site Number :3920020
Investigational Site Number :4100005
Investigational Site Number :1560007
Investigational Site Number :4100008
Investigational Site Number :1560043
Investigational Site Number :1520009
Investigational Site Number :8400066
Investigational Site Number :3800010
Investigational Site Number :3800006
Investigational Site Number :5280006
Investigational Site Number :0360002
Investigational Site Number :3800008
Investigational Site Number :0320003
Investigational Site Number :7240009
Investigational Site Number :1560005
Investigational Site Number :5280001
Investigational Site Number :8400084
Investigational Site Number :8400029
Investigational Site Number :2460002
Investigational Site Number :8260001
Investigational Site Number :8400078
Investigational Site Number :1560025
Investigational Site Number :1560001
Investigational Site Number :7920006
Investigational Site Number :1000001
Investigational Site Number :0760008
Investigational Site Number :3920006
Investigational Site Number :8400015
Investigational Site Number :4100009
Investigational Site Number :8400077
Investigational Site Number :1560054
Investigational Site Number :4100007
Investigational Site Number :0760006
Investigational Site Number :0320002
Investigational Site Number :1240007
Investigational Site Number :1560006
Investigational Site Number :1560036
Investigational Site Number :3480010
Investigational Site Number :1560013
Investigational Site Number :1560011
Investigational Site Number :6430008
Investigational Site Number :1520006
Investigational Site Number :1520002
Investigational Site Number :2500009
Investigational Site Number :7920005
Investigational Site Number :1240014
Investigational Site Number :6430006
Investigational Site Number :8400083
Investigational Site Number :8400082
Investigational Site Number :0360003
Investigational Site Number :7240005
Investigational Site Number :6430003
Investigational Site Number :2460001
Investigational Site Number :8400035
Investigational Site Number :7100006
Investigational Site Number :7920009
Investigational Site Number :3920008
Investigational Site Number :8400023
Investigational Site Number :8400086
Investigational Site Number :1520005
Investigational Site Number :3800007
Investigational Site Number :2500003
Investigational Site Number :3920017
Investigational Site Number :3920012
Investigational Site Number :3920013
Investigational Site Number :6160002
Investigational Site Number :4100006
Investigational Site Number :7020004
Investigational Site Number :8040010
Investigational Site Number :1240005
Investigational Site Number :7920001
Investigational Site Number :3920016
Investigational Site Number :3920022
Investigational Site Number :6200005
Investigational Site Number :6430009
Investigational Site Number :8400017
Investigational Site Number :1580007
Investigational Site Number :3480011
Investigational Site Number :1580002
Investigational Site Number :2030001
Investigational Site Number :1240002
Investigational Site Number :1240004
Investigational Site Number :0320004
Investigational Site Number :0560001
Investigational Site Number :3800003
Investigational Site Number :8400073
Investigational Site Number :7920011
Investigational Site Number :3920009
Investigational Site Number :1560021
Investigational Site Number :2030002
Investigational Site Number :3480005
Investigational Site Number :1560031
Investigational Site Number :2460003
Investigational Site Number :2500004
Investigational Site Number :1000004
Investigational Site Number :3800005
Investigational Site Number :8400068
Investigational Site Number :3920002
Investigational Site Number :8400028
Investigational Site Number :3480003
Investigational Site Number :8400059
Investigational Site Number :8400013
Investigational Site Number :8400056
Investigational Site Number :0400001
Investigational Site Number :2500006
Investigational Site Number :7100004
Investigational Site Number :2500007
Investigational Site Number :2760006
Investigational Site Number :8040002
Investigational Site Number :8040007
Investigational Site Number :2680007
Investigational Site Number :2760001
Investigational Site Number :6200001
Investigational Site Number :0320005
Investigational Site Number :3480001
Investigational Site Number :1560041
Investigational Site Number :3920019
Investigational Site Number :8400081
Investigational Site Number :8400010
Investigational Site Number :8400025
Investigational Site Number :1560018
Investigational Site Number :3920015
Investigational Site Number :5280005
Investigational Site Number :6430005
Investigational Site Number :8040001
Investigational Site Number :3920003
Investigational Site Number :8400039
Investigational Site Number :0560003
Investigational Site Number :1560051
Investigational Site Number :3800004
Investigational Site Number :7240004
Investigational Site Number :7920010
Investigational Site Number :0320010
Investigational Site Number :7920003
Investigational Site Number :1560046
Investigational Site Number :4100001
Investigational Site Number :8400002
Investigational Site Number :3920021
Investigational Site Number :6200002
Investigational Site Number :1560033
Investigational Site Number :7920004
Investigational Site Number :2760007
Investigational Site Number :6430007
Investigational Site Number :8400085
Investigational Site Number :8400008
Investigational Site Number :8400004
Investigational Site Number :6160007
Investigational Site Number :7920008
Investigational Site Number :8400053
Investigational Site Number :4100004
Investigational Site Number :3920018
Investigational Site Number :8400001
Investigational Site Number :1000005
Investigational Site Number :1560048
Investigational Site Number :0320001
Investigational Site Number :6430001
Investigational Site Number :2500002
Investigational Site Number :0320007
Investigational Site Number :3920001
Investigational Site Number :1560038
Investigational Site Number :8400005
Investigational Site Number :2500001
Investigational Site Number :6430004
Investigational Site Number :3920005
Investigational Site Number :1560035
Investigational Site Number :8400072
Investigational Site Number :3920007
Investigational Site Number :1580003
Investigational Site Number :0760004
Investigational Site Number :1560008
Investigational Site Number :1560019
Investigational Site Number :3920014
Investigational Site Number :1520011
Investigational Site Number :7240002
Investigational Site Number :1560002
Investigational Site Number :8400067
Investigational Site Number :2680005
Investigational Site Number :7020002
Investigational Site Number :0560004
Investigational Site Number :0560002
Investigational Site Number :0760005
Investigational Site Number :1560037
Investigational Site Number :7920007
Investigational Site Number :8400034
Investigational Site Number :1560003
Investigational Site Number :3480008
Investigational Site Number :8400080
Investigational Site Number :7240007
Investigational Site Number :7920012

title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation


type: EudraCT Number

title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

acronym: Verona

summary:
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

sponsor_collaborators:
AbbVie
Genentech, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 223573

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 219160

location_facility: Tennessee Oncology-Nashville Centennial /ID# 220854

location_facility: Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953

location_facility: Florida Cancer Specialists - North /ID# 221318

location_facility: Guangdong Provincial People's Hospital /ID# 221442

location_facility: New York Oncology Hematology - Albany Cancer Center /ID# 223778

location_facility: Willamette Valley Cancer Institute and Research Center /ID# 223733

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221233

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221170

location_facility: VA Ann Arbor Healthcare System /ID# 221365

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 222069

location_facility: Yamagata University Hospital /ID# 221574

location_facility: Fakultni nemocnice Hradec Kralove /ID# 221163

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704

location_facility: Maryland Oncology Hematology /ID# 223776

location_facility: Novant Health Presbyterian Medical Center /ID# 222561

location_facility: VA Caribbean Healthcare System /ID# 221012

location_facility: Helen F. Graham Cancer Center & Research Institute /ID# 223731

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 221274

location_facility: University Hospitals Bristol NHS Foundation Trust /ID# 222510

location_facility: Universitaetsklinikum Duesseldorf /ID# 221169

location_facility: Virginia Cancer Institute at Reynolds Crossing /ID# 221002

location_facility: Republican hospital named after V.A. Baranov /ID# 221214

location_facility: Lux Med Onkologia - Szpital Szamocka /Id# 222203

location_facility: Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 219163

location_facility: Hospital La Louviere Site Jolimont - Helora /ID# 218921

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727

location_facility: Yonsei University Health System Severance Hospital /ID# 233171

location_facility: Zhujiang Hospital of Southern Medical University /ID# 222071

location_facility: Almazov National Medical Research Centre /ID# 221449

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370

location_facility: Cardiff & Vale University Health Board /ID# 221236

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 220991

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494

location_facility: Ondokuz mayis University Facul /ID# 222091

location_facility: University Hospitals Dorset NHS Foundation Trust /ID# 221237

location_facility: Henan Provincial People's Hospital /ID# 225790

location_facility: Pusan National University Hospital /ID# 232353

location_facility: University College London Hospitals NHS Foundation Trust /ID# 221240

location_facility: Medizinische Hochschule Hannover /ID# 221173

location_facility: VA Puget Sound Health Care System /ID# 221358

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 220989

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567

location_facility: China Medical University Hospital /ID# 218987

location_facility: CHU Grenoble - Hopital Michallon /ID# 220988

location_facility: Gold coast University Hospital /ID# 222606

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 221231

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 221386

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189

location_facility: Torrance Memorial Physician Network Cancer Care /ID# 222702

location_facility: Hospital Universitário Pedro Ernesto /ID# 223080

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 221702

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703

location_facility: Maastricht Universitair Medisch Centrum /ID# 221630

location_facility: MTZ Clinical Research Powered by Pratia /ID# 221354

location_facility: Universitatsklinikum Mannheim /ID# 221172

location_facility: Hospital Universitario de Salamanca /ID# 221297

location_facility: Tel Aviv Sourasky Medical Center /ID# 221896

location_facility: Tianjin Medical University General Hospital /ID# 226810

location_facility: Florida Cancer Specialists - Fort Myers /ID# 221319

location_facility: Zhongda Hospital Southeast University /ID# 221849

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 221387

location_facility: Providence Medical Foundation /ID# 222633

location_facility: Texas Oncology - Northeast Texas /ID# 223734

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818

location_facility: Ustav hematologie a krevni transfuze /ID# 221350

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 220992

location_facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819

location_facility: Weill Cornell Medical College /ID# 222898

location_facility: Dana-Farber Cancer Institute /ID# 219162

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475

location_facility: University of Fukui Hospital /ID# 221568

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003

location_facility: Novant Health Forsyth Medical Center /ID# 221004

location_facility: Kobe City Medical Center General Hospital /ID# 221977

location_facility: Shaanxi Provincial people's Hospital /ID# 225728

location_facility: Beth Israel Deaconess Medical Center /ID# 225069

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 221474

location_facility: West China Hospital, Sichuan University /ID# 221601

location_facility: Lanzhou University Second Hospital /ID# 225980

location_facility: The First Affiliated Hospital of Soochow University /ID# 221640

location_facility: St Vincent's Hospital Melbourne /ID# 221809

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982

location_facility: Hadassah Medical Center-Hebrew University /ID# 222006

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321

location_facility: Stauferklinikum Schwaebisch Gmuend /ID# 224917

location_facility: National Cheng Kung University Hospital /ID# 218989

location_facility: Florida Cancer Specialists - East /ID# 221317

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705

location_facility: Virginia Cancer Specialists - Gainesville /ID# 223726

location_facility: Seoul National University Bundang Hospital /ID# 221695

location_facility: The Second Hospital of Hebei Medical University /ID# 222919

location_facility: Hospital General Universitario Gregorio Maranon /ID# 221271

location_facility: Shanghai Sixth People's Hospital /ID# 221546

location_facility: Seoul National University Hospital /ID# 221226

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 221590

location_facility: Hospital Universitario 12 de Octubre /ID# 221272

location_facility: Port Macquarie Base Hospital /ID# 234078

location_facility: Texas Oncology - Forth Worth /ID# 223777

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810

location_facility: Texas Oncology - Medical City Dallas /ID# 223725

location_facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918

location_facility: Erciyes University Medical Fac /ID# 222090

location_facility: Tennessee Oncology - Chattanooga / McCallie /ID# 221311

location_facility: Hospital Universitario y Politecnico La Fe /ID# 221270

location_facility: PIH Health Whittier Hospital /ID# 222647

location_facility: Rush University Medical Center /ID# 221007

location_facility: Massachusetts General Hospital /ID# 225068

location_facility: The First Affiliated Hospital of Nanchang University /ID# 225983

location_facility: Hacettepe University Faculty of Medicine /ID# 222094

location_facility: The Chaim Sheba Medical Center /ID# 221110

location_facility: Hospital Universitario Reina Sofia /ID# 221273

location_facility: Nagasaki University Hospital /ID# 222241

location_facility: The Royal Marsden NHS Foundation Trust /ID# 221232

location_facility: University Hospital Plymouth NHS Trust /ID# 222514

location_facility: University of California, Los Angeles /ID# 221760

location_facility: Texas Oncology - Austin Midtown /ID# 223729

location_facility: Universitaetsklinikum Leipzig /ID# 221168

location_facility: Northwestern University Feinberg School of Medicine /ID# 220843

location_facility: Stony Brook University Hospital /ID# 224450

location_facility: Baylor Scott & White Medical Center- Temple /ID# 221332

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667

location_facility: McGill University Health Center Research Institute /ID# 222519

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200

location_facility: Akdeniz Universitesi Tip Fakul /ID# 222095

location_facility: Pan American Center for Oncology Trials, LLC /ID# 221010

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816

location_facility: Hospital Universitario Virgen del Rocio /ID# 221276

location_facility: CHU UCL Namur - site Godinne /ID# 219064

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 221229

location_facility: CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973

location_facility: National Hospital Organization Mito Medical Center /ID# 222278

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 222074

location_facility: AP-HM - Hopital de la Conception /ID# 224882

location_facility: Rocky Mountain Cancer Centers /ID# 223723

location_facility: Shengjing Hospital of China Medical University /ID# 222945

location_facility: Peking University International Hospital /ID# 222987

location_facility: Nanfang Hospital of Southern Medical University /ID# 224566

location_facility: Florida Cancer Specialists - Panhandle /ID# 221315

location_facility: Ottawa Hospital Research Institute /ID# 219105

location_facility: Hospital Universitario Walter Cantidio /ID# 223434

location_facility: Texas Oncology - San Antonio Medical Center /ID# 223728

location_facility: Kaluga Regional Clinical Hospital /ID# 221211

location_facility: Pontchartrain Cancer Center - Covington /ID# 221005

location_facility: Universitair Ziekenhuis Leuven /ID# 218905

location_facility: Fukushima Medical University Hospital /ID# 222015

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopern /Id# 221784

location_facility: Hospital Universitario Quironsalud Madrid /ID# 221275

location_facility: Sunnybrook Health Sciences Ctr /ID# 219103

location_facility: Medizinische Universitaet Wien /ID# 221446

location_facility: Hospital Universitario Vall d'Hebron /ID# 221323

location_facility: Liga Paranaense de Combate ao Câncer /ID# 221341

location_facility: St. Luke's Mountain State Tumor Institute /ID# 220838

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221092

location_facility: Oncology Hematology Care, Inc. /ID# 223724

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: ADjoin

intervention_type: Biological

lead_sponsor: Eli Lilly and Company

summary: This 110-week study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.

sponsor_collaborators:
Eli Lilly and Company
Dermira, Inc.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny Anna Ploszczuk

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2

location_facility: Zespol Naukowo - Leczniczy "Iwolang" Sp. z o.o.

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

location_facility: University of South Florida College of Medicine

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Dermatology and Skin Cancer Specialists, LLC

location_facility: International Dermatology Research, Inc.

location_facility: Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD

location_facility: Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council

location_facility: Simcoderm Medical & Surgical Dermatology Centre

location_facility: Center For Dermatology Clinical Research, Inc.

location_facility: Skin Laser and Surgery Specialists, a Division of Schweiger Dermatology

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

location_facility: Rivne Regional Dermatology and Venereology Dispensary

location_facility: University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii

location_facility: Clinical Research Center of Alabama- Birmingham

location_facility: California Dermatology & Clinical Research Institute

location_facility: SE "Institute of Dermatology and Venerology of NAMS of Ukraine"

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Soon Chun Hyang University Bucheon Hospital

location_facility: Hospital Universitario Infanta Leonor-INTERNAL MED

location_facility: Riverchase Dermatology and Cosmetic Surgery

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kansas Medical Clinic, an Elligo Health Research, Inc.

location_facility: Dermatology Treatment and Research Center

location_facility: Company for Medical Study & Service Selters GmbH

location_facility: Hospital General Universitario de Alicante

location_facility: JSC "Center for Diagnosis and Treatment of Allergic Diseases"

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: University of the Sunshine Coast Clinical Trial Centre

location_facility: Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak

location_facility: Smite Aija - Doctor Practice in Dermatology Venereology

location_facility: Treatment-diagnostic center PE "Asclepius"

location_facility: Rivergate Dermatology Clinical Research Center PL

location_facility: Velocity Clinical Research - Woseth Dermatology

location_facility: Keck School of Medicine University of Southern California

location_facility: Northwest Arkansas Clinical Trials Center

location_facility: Vital Prospects Clinical Research Institute, PC

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Clinical Research Center of the Carolinas

location_facility: George Washington University Medical Center

location_facility: California Allergy and Asthma Medical Group + Research Center

location_facility: University Hospitals Case Medical Center

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Ablon Skin Institute and Research Center

location_facility: Vilnius University Hospital Santaros Klinikos

title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

type: Other Identifier

source: euctr

enrollment_type: Anticipated

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

design_allocation: Non-Randomized

location_country:
Germany
Lithuania
Poland
Singapore
Australia
Mexico
United States
Korea, Republic of
Latvia
Spain
Canada
Taiwan
Ukraine
Bulgaria
Estonia
France


lead_sponsor: Hoffmann-La Roche

summary: This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.

location_facility: Svendborg Sygehus; Neurologisk afdeling N, Demensklinik Fyn

location_facility: Tokyo Medical and Dental University Hospital

location_facility: National Clinical Research Inc.-Richmond

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Hyogo Prefectural HarimaHimeji General Medical Center

location_facility: Australian Alzheimer's Research Foundation

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hospital da Senhora da Oliveira-Guimarães; Serviço de Neurologia

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: National Hospital Organization Hizen Psychiatric Medical Center

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: National Taiwan University Hospital; Neurology

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Surrey and Borders NHS Foundation Trust; Research and Development Department

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Beijing Tian Tan Hospital,Capital Medical University

location_facility: The Cognitive and Research Center of New Jersey

location_facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Semmelweis University; Department of Neurology

location_facility: University of Nebraska Medical Center; Dept of Neurological Sciences

location_facility: Ohio State University; College of Medicine

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: National Center for Geriatrics and Gerontology

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Medical corporation Ichiekai Itsuki Hospital

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: City Polyclinic No. 2 of the Department of Healthcare of the City of Moscow

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Cleveland Clinic; Cleveland Lou Ruvo Center for Brain Health ? Neurological Institute

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Hospital Victoria Eugenia; Servico Neurología

location_facility: University Southampton NHS Foundation Trust; Wessex Neurologica Centre

location_facility: AD-CARE, University of Rochester Medical Center

location_facility: Neurologiczny NZOZ Centrum Leczenia SM; Osrodek Badan Klinicznych

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Complejo Asistencial de Zamora; Servicio Psiquiatria

location_facility: Center for Advanced Research & Education

location_facility: Neurological Associates of Long Island, PC

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Demensklinikken

location_facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi

location_facility: Research Center for Clinical Studies, Inc.

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Center for Diagnosis and Research on Alzheimer's disease

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: The Medical Arts Health Research Group - West Vancouver

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Hospital Universitario de Santa Maria; Servicio de Neurología

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: The University of Texas Health Science Center at Houston

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Southern Illinois University, School of Medicine

location_facility: O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Alzheimer?s Research and Treatment Center

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: China Medical University Hospital; Neurology

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: MHI City Clinical Hospital #2 named after V.I. Razumovsky; Psychiatric

location_facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: CEN Centro Especializado en Neurociencias

location_facility: Allied Biomedical Research Institute, Inc

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez UANL; Depto.de NeurologíaPta.BajaConsulta

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Fundación Scherbovsky; General Department

location_facility: The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

location_facility: Neurology Consultants of Dallas; Research Department

location_facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Advanced Memory Research Institute of NJ

location_facility: University of Puerto Rico - Medical Science Campus; Internal Medicine

location_facility: Tokyo Bay Advanced Medical and Makuhari Clinic

location_facility: University of Mississippi Medical Center

location_facility: Instituto Geriatrico Nuestra Señora de las Nieves

location_facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

status: Terminated

title: An Open-Label, Multicenter, Rollover Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

study_completion_date_type: Actual

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Lithuania
Portugal
Hungary
Denmark
United States
Belgium
China
Peru
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden

status_simplified: Unknown


title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)

summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

collaborators: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Poland
Brazil
Thailand
Turkey
Canada
France
Slovenia
Belarus
Lithuania
Portugal
Slovakia
Switzerland
United States
Latvia
Ukraine
India
Romania
Malaysia
Moldova, Republic of
Puerto Rico
Philippines
Italy
Norway
Singapore
Saudi Arabia
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden

location_facility:
Research Site 252
Research Site 493
Research Site 351
Research Site 571
Research Site 540
Research Site 158
Research Site 455
Research Site 182
Research Site 629
Research Site 759
Research Site 344
Research Site 346
Research Site 145
Research Site 513
Research Site 321
Research Site 725
Research Site 594
Research Site 582
Research Site 203
Research Site 218
Research Site 278
Research Site 314
Research Site 502
Research Site 325
Research Site 105
Research Site 371
Research Site 207
Research Site 293
Research Site 263
Research Site 173
Research Site 191
Research site 483
Research Site 628
Research Site 202
Research Site 281
Research Site 213
Research Site 181
Research Site 381
Research Site 539
Research Site 184
Research Site 382
Research Site 417
Research Site 204
Reserach Site 268
Research Site 737
Research Site 726
Research Site 177
Research Site 232
Research Site 302
Research Site 501
Reserach Site 267
Research Site 101
Research Site 403
Research Site 414
Research Site 143
Research Site 326
Research Site 352
Research Site 443
Research Site 354
Research Site 714
Research Site 562
Research Site 803
Research Site 264
Research Site 386
Research Site 328
Research Site 743
Research Site 233
Research Site 330
Research Site 402
Research Site 632
Research Site 174
Research Site 211
Research Site 751
Research Site 171
Research Site 512
Research Site 444
Research site 274
Research Site 718
Research Site 160
Research Site 262
Research Site 345
Research Site 457
Research Site 482
Research Site 335
Research Site 212
Research Site 159
Research Site 583
Research Site 339
Research Site 802
Research Site 746
Research Site 270
Research Site 334
Research Site 342
Research Site 372
Research Site 624
Research Site 504
Research Site 625
Research Site 551
Research Site 329
Research Site 217
Research Site 724
Research Site 176
Research Site 231
Research Site 717
Research Site 273
Research Site 261
Research Site 107
Research Site 179
Research Site 332
Research Site 591
Research Site 154
Research Site 220
Research Site 630
Research Site 705
Research Site 801
Research site 242
Research Site 753
Research Site 734
Research Site 288
Research Site 106
Research Site 537
Research Site 808
Research Site 413
Research Site 392
Research Site 141
Research Site 331
Research Site 221
Research SIte 284
Research Site 142
Research Site 702
Research Site 272
Research Site 411
Research Site 338
Research Site 556
Research Site 418
Research Site 276
Research Site 216
Research site 572
Research Site 385
Research Site 327
Research Site 596
Research Site 614
Research Site 251
Research Site 155
Research Site 384
Research Site 721
Research Site 531
Research Site 343
Research Site 552
Research Site 219
Research Site 626
Research Site 266
Research Site 416
Research Site 621
Research Site 741
Research Site 459
Research Site 633
Research Site 287
Research Site 543
Research Site 703
Research Site 454
Research Site 172
Research Site 728
Research Site 600
Research Site 194
Research Site 196
Research Site 323
Research Site 503
Research Site 144
Research Site 631
Research Site 553
Research Site 357
Research Site 283
Research Site 388
Research Site 538
Research Site 271
Reserach Site 206
Research Site 291
Research Site 752
Research Site 359
Research Site 199
Research site 243
Research Site 337
Research Site 738
Research Site 544
Research Site 183
Research Site 390
Research Site 732
Research Site 706
Research Site 265
Research Site 603
Research Site 561
Research Site 307
Research Site 153
Research Site 452
Research Site 604
Research Site 623
Research site 514
Research Site 742
Research Site 391
Research Site 389
Research Site 719
Research Site 534
Research Site 458
Research Site 215
Research Site 711
Research Site 757
Research Site 292
Research Site 205
Research Site 156
Research Site 536
Research site 846
Research Site 704
Research Site 533
Research Site 805
Research Site 151
Research Site 358
Research Site 373
Research Site 420
Research Site 723
Research Site 456
Research Site 214
Research Site 289
Research Site 740
Research Site 735
Research Site 157
Research Site 712
Research Site 541
Research Site 415
Research Site 748
Research Site 599
Research Site 277
Research Site 180
Research Site 286
Research Site 622
Research Site 744
Reserach Site 275
Research Site 340
Research Site 791
Research Site 353
Research Site 532
Research Site 404
Research Site 707
Research Site 481
Research Site 804
Research Site 387
Research Site 197
Research Site 412
Research Site 198
Research Site 554
Research Site 222
Research Site 511
Research Site 715
Research Site 535
Research Site 419
Reserach Site 451
Research Site 609
Research Site 442
Research Site 201
Research Site 341
Research Site 192
Research Site 453
Research Site 178
Research site 244
Research Site 736
Research site 241
Research Site 445
Research Site 309
Research Site 627
Research Site 152
Research Site 175
Research Site 383
Research Site 356
Research Site 195
Research Site 282
Research Site 324


lead_sponsor: AstraZeneca

summary: Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Poland
Argentina
Australia
Japan
Canada
France
Hungary
United States
Belgium
China
Peru
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: PRELUDE

lead_sponsor: Novartis Pharmaceuticals

summary: The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.

ReferenceCitation: Miteva M, Nadji M, Billero V, LaSenna C, Nattkemper L, Romanelli P. IL-17 Expression in the Perifollicular Fibrosis in Biopsies From Lichen Planopilaris. Am J Dermatopathol. 2022 Dec 1;44(12):874-878. doi: 10.1097/DAD.0000000000002316. Epub 2022 Sep 27.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

status: Completed

title: A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
United States
Germany
France

status_simplified: Completed


title: Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

acronym: ADHERE+

summary:
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Germany
Poland
Japan
Turkey
Czechia
Serbia
France
Denmark
United States
Latvia
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
Investigator site 0390026
Investigator site 0010059
Investigator site 0860034
Investigator site 0860028
Investigator site 0440016
Investigator site 0340038
Investigator site 330033
Investigator site 0010061
Investigator site 0860040
Investigator site 490021
Investigator site 0310010
Investigator site 3590008
Investigator site 0810003
Investigator site 8860013
Investigator site 860047
Investigator site 0860045
Investigator site 0480018
Investigator site 3810004
Investigator site 0860029
Investigator site 900021
Investigator site 0010065
Investigator site 0450002
Investigator site 9950020
Investigator site 9950004
Investigator Site 0480017
Investigator site 0490019
Investigator site 0010023
Investigator site 0860043
Investigator site 0390024
Investigator site 0810031
Investigator site 3100013
Investigator site 0860050
Investigator site 31
Investigator site 0330023
Investigator site 9950002
Investigator site 10168
Investigator site 0390023
Investigator site 0340021
Investigator site 0320009
Investigator site 0010055
Investigator site 0010003
Investigator site 860035
Investigator site 900022
Investigator site 0860032
Investigator site 9950005
Investigator site 0480024
Investigator site 0010011
Investigator site 040001
Investigator site 0330021
Investigator site 320022
Investigator site 0860048
Investigator site 0010068
Investigator site 0810064
Investigator site 440026
Investigator site 0390008
Investigator site 0010015
Investigator site 320024
Investigator site 0390022
Investigator site 0810027
Investigator site 0010144
Investigator Site 9950003
Investigator site 040002
Investigator site 3810003
Investigator site 3800008
Investigator site 0010072
Investigator site 0340018
Investigator site 10147
Investigator site 0860036
Investigator site 0810026
Investigator site 0860038
Investigator site 0860054
Investigator site 3800011
Investigator site 0310011
Investigator site 3590005
Investigator site 0010007
Investigator site 0010160
Investigator site 0810063
Investigator site 0810032
Investigator site 0010071
Investigator site 0810029
Investigator site 040003
Investigator site 0450003
Investigator site 490044
Investigator site 0860031
Investigator Site 3800012
Investigator site 390027
Investigator site 00330034
Investigator site 0320016
Investigator site 0010057
Investigator Site 0010066
Investigator site 0010009
Investigator site 0810065
Investigator site 70021
Investigator site 0810058
Investigator site 0070014
Investigator site 070017
Investigator site 3590006
Investigator site 330022
Investigator site 390029
Investigator site 8860016
Investigator site 9720004
Investigator site 0810036
Investigator site 0010013
Investigator site 810061
Investigator site 0430007
Investigator site 860041
Investigator site 0010064
Investigator site 0330013
Investigator site 0810066
Investigator site 8860017
Investigator site 0430005
Investigator site 490045
Investigator site 0010006
Investigator site 0810007
Investigator site 0070019
Investigator site 0480020
Investigator site 0430008
Investigator site 0860042
Investigator site 10190
Investigator site 0440018
Investigator site 0390042
Investigator site 0860035
Investigator site 860049
Investigator site 0330020
Investigator site 0070023
Investigator site 8860012
Investigator Site 3800010
Investigator site 0860033
Investigator site 0480022
Investigator site 900025
Investigator site 3810001
Investigator site 0010032
Investigator site 0450001
Investigator site 0490016
Investigator site 0810035
Investigator site 040004
Investigator site 0810030
Investigator site 0490013
Investigator site 0010047
Investigator site 0070020
Investigator site 0810060
Investigator site 4200010
Investigator site 0390003
Investigator site 3590007
Investigator site 0330035
Investigator site 0810002
Investigator site 0330024
Investigator site 0070021


summary:
Primary Objectives:

Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM)
Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM

Secondary Objectives:

Safety run-in

To assess overall response rate (ORR)
To assess duration of response (DOR)
To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR)
To assess time to diagnostic (SLiM CRAB) progression or death
To assess time to first-line treatment for multiple myeloma (MM)
To assess the potential immunogenicity of isatuximab
Impact of abnormal cytogenetic subtype on participant outcome

Randomized Phase 3 - Key Secondary Objectives:

To compare between the arms

MRD negativity
Sustained MRD negativity
Second progression-free survival (PFS2)
Overall survival

Other Secondary Objectives:

To evaluate in both arms

CR rate
ORR
DOR
Time to diagnostic (SLiM CRAB) progression
Time to biochemical progression
Time to first-line treatment for MM
Safety and tolerability
Pharmacokinetics (PK)
Potential of isatuximab immunogenicity
Clinical outcome assessments (COAs)

location_facility: Novant Health Forsyth Medical Center-Site Number:8401015

location_facility: Cancer Specialist of North Florida-Site Number:8400011

location_facility: ~University of Texas - MD Anderson Cancer Center-Site Number:8400002

location_facility: Dana Farber Cancer Institute-Site Number:8400001

location_facility: Tennessee Oncology, PLLC-Site Number:8400006

location_facility: Colorado Blood Cancer Institute-Site Number:8400007

status: Recruiting

title: A Phase 3 Randomized, Open Label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

type: Registry Identifier

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Canada
France
Lithuania
Hungary
Denmark
United States
China
Italy
Norway
United Kingdom
Sweden
Korea, Republic of
Spain
Greece
Israel


study_start_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

sponsor_collaborators:
Janssen Research & Development, LLC
argenx

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Instituto do cancer -COR -Hospital Mae de Deus

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Klinikum rechts der Isar an der Technischen Universität München

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

status: Withdrawn

title: A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Italy
United Kingdom
Australia
Brazil
Switzerland
Saudi Arabia
Spain
Turkey
Russian Federation
France


acronym: BE HEARD II

lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Ireland
Poland
Hungary
Israel
United Kingdom
Australia
Japan
United States
Spain
Czechia
Bulgaria
Canada
France


title: A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects With Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

acronym: REGAL

summary: To assess the safety and efficacy of galinpepimut-S (GPS) compared with investigator's choice of best available therapy (BAT) on overall survival (OS) in subjects with acute myeloid leukemia (AML) who are in second or later complete remission (CR2) or second or later complete remission with incomplete platelet recovery (CRp2).

ipd_sharing: No

lead_sponsor: Sellas Life Sciences Group

location_country:
Germany
Poland
India
Hungary
United States
Spain
Greece
Taiwan
Serbia
France

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: The Oncology Institute of Hope and Innovation

location_facility: University Hospitals Cleveland Medical Center

location_facility: General Hospital of Athens "Evaggelismos"

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: General Hospital of Athens "Ηippokration"

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: State Cancer Institute, Indira Gandhi Institute of Medical Sciences

location_facility: University General Hospital of Thessaloniki "Ahepa"

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: University General Hospital of Alexandroupoli

location_facility: Baylor Scott and White Research Institute

location_facility: Colorado Blood Cancer Institute - SCRI - PPDS


summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Centre Hospitalier Troyes; Service Oncologie Médicale

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

location_facility: Barts Health NHS Trust; Cancer Research Delivery Group

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2

location_facility: Townsville Hospital; Haematology and Oncology

location_facility: Rutherford Cancer Centre ? Thames Valley

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Churchill Hospital; Department of Oncology

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Texas Tech University Health Sciences Center; Department of Internal Medicine

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen

location_facility: Narodowy Instytut Onkologii Odzia? w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Opolskie Centrum Onkologii; Onkologia Kliniczna z Odcinkiem Dziennym

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: The First People's Hospital of Foshan; Local Ethic Committee

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Hosp Provincial D. Centenarios; Oncology Dept

location_facility: Kyungpook National University Medical Center

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: London Regional Cancer Program, London Health Sciences Centre, Baines Centre

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: Winship Cancer Institute of Emory University

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Blokhin Cancer Research Center; Out-Patients Dept

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO)

location_facility: Universitätsfrauenklinik Ulm; Abteilung Gynäkologie

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

location_facility: Seoul National University Bundang Hospital

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Harbin Medical University Cancer Hospital

location_facility: Israel-Georgian Medical Research Clinic Healthycore

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Wake Forest University Baptist Medical Center

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

location_facility: Mount Vernon Hospital; Mount Vernon Cancer Centre

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Ambulatorium Chemioterapii

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Azienda Ospedaliera Univ di Udine; Oncologia Medica

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring

location_facility: Waikato Hospital; Dept of Medical Oncology

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Kaiser Permanente;Clinical Trials Department

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Ukraine
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Georgia
Russian Federation


acronym: CUPID

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)

Secondary Objectives:

To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility: National Allergy and ENT Site Number : 8400011

location_facility: Immunocarolina LLC Site Number : 8400010

location_facility: Sarasota Clinical Research Site Number : 8400017

location_facility: The Clinical Research Center, LLC Site Number : 8400009

location_facility: UR Dermatology at College Town Site Number : 8400008

location_facility: Bernstein Clinical Research Center Site Number : 8400014

location_facility: University of South Florida Site Number : 8400006

location_facility: California Allergy and Asthma Medical Group, Inc. Site Number : 8400019

location_facility: Lenus Research & Medical Group Site Number : 8400001

location_facility: Johns Hopkins University (Asthma and Allergy Center) Site Number : 8400016

location_facility: STAAMP Research, LLC Site Number : 8400007

location_facility: Allergy & Asthma Specialists, PSC Site Number : 8400020

location_facility: Aeroallergy Research Laboratories of Savannah, INC Site Number : 8400018

location_facility: Vital Prospects Clinical Research Institute, P.C. Site Number : 8400015

location_facility: Pharmaceutical Research & Consulting, Inc. Site Number : 8400003

title: Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

location_country:
Germany
Hungary
Argentina
United Kingdom
Japan
United States
China
Spain
Canada
Russian Federation
France


acronym: Falcon

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to severely active ulcerative colitis (UC).

location_facility: Medizinische Universitat Wien Klinik fur Innere Medizin III/Abt. fur Gastroenterologie and Hepatologie

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Inselspital Bern/Klinik fur Viszerale Chirurgie und Medizin/Bauchzentrum

location_facility: Universitätsspital Zürich/Klinik für Gastroenterologie und Hepatologie

location_facility: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

location_facility: Centre Hospitalier Universitaire de Grenoble Alpes

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Gut P.C., dba Digestive Health Specialists of the Southeast

location_facility: Encore Borland-Groover Clinical Research

location_facility: "GASTROMED" Kopon, Zmudzinski i Wsp. Sp. J. Spec. Centrum Gastrologii i Endoskopii, Spec. Gabinety Lekarskie

location_facility: Clinical Associates in Research Therapeutics of America, LLC

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner/Crohn-Colitis-Zentrum

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Health Care Centre

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik fur Innere Medizin I, Haus C, Haus K3

title: A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
Germany
Italy
Poland
Australia
Switzerland
Austria
United States
Canada
France


summary: This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

ReferenceCitation: Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30. Erratum In: Future Oncol. 2020 Oct;16(29):2371.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

location_facility: Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The First Affiliated Hospital of China Medical University

location_facility: Hospital do Cancer UOPECCAN; Pesquisa Clínica

location_facility: Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Daping Hospital of Third Military Medical University

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie

location_facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

location_facility: Affiliated Hospital of Bengbu Medical College

location_facility: Zhujiang Hospital, Southern Medical University

location_facility: Shengjing Hospital of China Medical University

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology

location_facility: Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: CHU Bordeaux - Hôpital Haut-Lévêque; Service d?Hépato-Gastroentérologie et d Oncologie digestive

location_facility: The Second Affiliated Hospital of Dalian Medical University

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Taipei Veterans General Hospital; Gastroenterology Division

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: The Tumor Hospital of Xinjiang Medical University

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Mengchao Hepatobiliary Hospital Of Fujian Medical University

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Hopital de Pontchaillou; Service Hepato Gastro Enterologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: McGill University Health Centre - Glen Site

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: The First Affiliate Hospital of Guangxi Medical University

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

title: A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Costa Rica
Japan
Thailand
Turkey
Czechia
Canada
France
Hong Kong
United States
Belgium
China
Peru
Italy
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

summary: The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Germany
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Portugal
Hungary
Hong Kong
United States
Italy
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation

location_facility: Articularis Healthcare Group Inc dba Low Country Rheumatology

location_facility: The Oklahoma Center for Arthritis Therapy and Research Inc

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Feinstein Institute for Medical Research

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Instituto Medico de Alta Complejidad San Isidro

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

location_facility: Groupe de recherche en maladies osseuses Incorporated

location_facility: University of Calgary Cumming School of Medicine

location_facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

location_facility: Penn State Milton South Hershey Medical Center

location_facility: Rheumatic Disease Clinical Research Center LLC

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: University of Maryland School of Medicine Division of Rheumatology

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Austin Regional Clinic Specialty Research

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: Multiprofile Hospital for Active Treatment Trimontium OOD

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: Centre for Rheumatology Immunology and Arthritis

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: New York University Langone Orthopedic Center

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Tomed Tomasz Miszalski-Jamka Centrum Medyczne

location_facility: Synexus Polska Spolka z ograniczona odpowiedzialnoscia

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Trinity Universal Research Associates, Inc

location_facility: Fundacion Respirar - Centro Medico Dra De Salvo

location_facility: Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

location_facility: University Multiprofile Hospital for Active Treatment - Kaspela EOOD

location_facility: FSBSI SRI of Rheumatology na V A Nasonova

location_facility: Limited liability company Scientific Research Medical Complex Your Health

location_facility: Centro Mexicano de Desarrollo de Estudios Clinicos

location_facility: Southwest Florida Clinical Research Center

location_facility: CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: Centro Peninsular de Investigación Clínica

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

location_facility: Centro Hospitalar Universtario de Sao Joao, EPE

location_facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

location_facility: Hospital of the University of Occupational and Environmental Health Japan

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Shared Health Inc. operating the Health Sciences Centre Winnipeg

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Southern California Permanente Medical Group

location_facility: Morales Vargas Centro de Investigacion SC

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Stanford University Hospitals and Clinics

location_facility: Medical Centre Synexus Sofia EOOD - Branch Stara Zagora

location_facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

location_facility: Arthritis and Rheumatology Center of Oklahoma PLLC


title: Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

summary: This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country:
United Kingdom
Denmark
Austria
Belgium
France

location_facility: CHU de Clermont-Ferrand - Hôpital Estaing

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: CHU Haut-Lévèque - Centre François Magendie

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme

location_facility: University Hospital for Internal Medicine - University Hospital Graz