acronym: Viale-a

title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

ReferenceCitation: Pratz KW, Chai X, Xie J, Yin L, Nie X, Montez M, Iantuono E, Downs L, Ma E. Cost-Effectiveness Analysis of Venetoclax in Combination with Azacitidine Versus Azacitidine Monotherapy in Patients with Acute Myeloid Leukemia Who are Ineligible for Intensive Chemotherapy: From a US Third Party Payer Perspective. Pharmacoeconomics. 2022 Aug;40(8):777-790. doi: 10.1007/s40273-022-01145-7. Epub 2022 Jun 13.

ReferenceCitation: Konopleva M, Thirman MJ, Pratz KW, Garcia JS, Recher C, Pullarkat V, Kantarjian HM, DiNardo CD, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Wei AH. Impact of FLT3 Mutation on Outcomes after Venetoclax and Azacitidine for Patients with Treatment-Naïve Acute Myeloid Leukemia. Clin Cancer Res. 2022 Jul 1;28(13):2744-2752. doi: 10.1158/1078-0432.CCR-21-3405.

ReferenceCitation: Pollyea DA, DiNardo CD, Arellano ML, Pigneux A, Fiedler W, Konopleva M, Rizzieri DA, Smith BD, Shinagawa A, Lemoli RM, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Kantarjian HM. Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. Clin Cancer Res. 2022 Jul 1;28(13):2753-2761. doi: 10.1158/1078-0432.CCR-21-3467.

ReferenceCitation: Pratz KW, Jonas BA, Pullarkat V, Recher C, Schuh AC, Thirman MJ, Garcia JS, DiNardo CD, Vorobyev V, Fracchiolla NS, Yeh SP, Jang JH, Ozcan M, Yamamoto K, Illes A, Zhou Y, Dail M, Chyla B, Potluri J, Dohner H. Measurable Residual Disease Response and Prognosis in Treatment-Naive Acute Myeloid Leukemia With Venetoclax and Azacitidine. J Clin Oncol. 2022 Mar 10;40(8):855-865. doi: 10.1200/JCO.21.01546. Epub 2021 Dec 15.

ReferenceCitation: DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Döhner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hájek R, Porkka K, Illés Á, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

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.

location_country:
Croatia
Spain
Italy
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Norway
Sweden
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France

location_facility: Princess Margaret Cancer Centre /ID# 153651

location_facility: Hospital Universitario de la Princesa /ID# 153256

location_facility: Kuzbass Regional Clinical Hospital /ID# 157461

location_facility: Ospedale Policlinico San Martino /ID# 158104

location_facility: Hospital Universitario 12 de Octubre /ID# 153258

location_facility: Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268

location_facility: Hospital Universitario y Politecnico La Fe /ID# 153259

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 153789

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854

location_facility: West China Hospital, Sichuan University /ID# 167492

location_facility: Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876

location_facility: Fujian Medical University Union Hospital /ID# 167314

location_facility: VA Caribbean Healthcare System /ID# 160507

location_facility: Nagasaki University Hospital /ID# 168632

location_facility: University of Fukui Hospital /ID# 167432

location_facility: University of Texas MD Anderson Cancer Center /ID# 154100

location_facility: Yamagata University Hospital /ID# 167634

location_facility: China Medical University Hospital /ID# 153904

location_facility: Helsinki University Hospital /ID# 155223

location_facility: The First Hospital of Jilin University /ID# 167490

location_facility: Ottawa Hospital Research Institute /ID# 153541

location_facility: Qilu Hospital of Shandong University /ID# 167485

location_facility: Sepctrum Health Medical Center /ID# 159522

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385

location_facility: Ondokuz Mayis Universitesi Tip /ID# 155201

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315

location_facility: Kyiv Regional Onco Dispensary /ID# 153514

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056

location_facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267

location_facility: Kyiv city clinical hospital #9 /ID# 153510

location_facility: National Taiwan University Hospital /ID# 153900

location_facility: Aichi Cancer Center Hospital /ID# 200824

location_facility: Northwestern University Feinberg School of Medicine /ID# 201133

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487

location_facility: Universitaetsklinikum Halle (Saale) /ID# 153058

location_facility: Medizinische Hochschule Hannover /ID# 153055

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493

location_facility: Columbia Univ Medical Center /ID# 154101

location_facility: Seoul National University Hospital /ID# 153675

location_facility: Akershus universitetssykehus /ID# 154279

location_facility: State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460

location_facility: Ankara Universitesi Fakultesi /ID# 155200

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

location_facility: Fakultni nemocnice Hradec Kralove /ID# 154021

location_facility: Hospital General Universitario Gregorio Maranon /ID# 153260

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812

location_facility: Tennessee Oncology-Nashville Centennial /ID# 200854

location_facility: Tel Aviv Sourasky Medical Center /ID# 154175

location_facility: Duplicate_Landeskrankenhaus Salzburg /ID# 169719

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

location_facility: Duplicate_Semmelweis Egyetem /ID# 153815

location_facility: Universitaetsklinikum Muenster /ID# 153059

location_facility: Instituto de Ensino e Pesquisa São Lucas /ID# 157778

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 155136

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846

location_facility: The Chaim Sheba Medical Center /ID# 154173

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 153814

location_facility: Medizinische Universitaet Graz /ID# 157882

location_facility: Universitaetsklinikum St. Poelten /ID# 167436

location_facility: Hospital Universitario de Navarra /ID# 153254

location_facility: University of California, Los Angeles /ID# 154107

location_facility: University Of Vermont Medical /ID# 157196

location_facility: Emory Midtown Infectious Disease Clinic /ID# 162534

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 201111

location_facility: Hospital Santa Creu i Sant Pau /ID# 153193

location_facility: Duplicate_Konkuk University Medical Ctr /ID# 153973

location_facility: Hospital Universitario Virgen de la Victoria /ID# 153257

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639

location_facility: Duplicate_Kyoto Prefectural University of Medicine /ID# 167661

location_facility: Moscow State budget healthcare /ID# 155738

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 152881

location_facility: Haukeland University Hospital /ID# 154281

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220

location_facility: Saitama Medical University International Medical Center /ID# 167814

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 168316

location_facility: Presidio Ospedaliero Vito Fazzi /ID# 170837

location_facility: Osaka Metropolitan University Hospital /ID# 169055

location_facility: Baylor Scott & White Medical Center- Temple /ID# 157191

location_facility: National Hospital Organization Mito Medical Center /ID# 168219

location_facility: Samara State Medical University /ID# 157462

location_facility: University of Chicago Medicine /ID# 154108

location_facility: The Second Hospital of Hebei Medical University /ID# 167316

location_facility: Hacettepe University Faculty of Medicine /ID# 202073

location_facility: Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

location_facility: Massachusetts General Hospital /ID# 200752

location_facility: Duplicate_Kindai University Hospital /ID# 167662

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389

location_facility: Dana-Farber Cancer Institute /ID# 167009

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 162725

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877

location_facility: Juntendo University Hospital /ID# 168309

location_facility: Poltava Reg Clin Hosp Sklifoso /ID# 153513

location_facility: Karolinska University Hospital /ID# 170003

location_facility: Nanfang Hospital of Southern Medical University /ID# 170148

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157779

location_facility: Universitaetsklinikum Frankfurt /ID# 153060

location_facility: Hospital Clinic de Barcelona /ID# 153255

location_facility: The Jikei University Daisan Hospital /ID# 168745

location_facility: The Royal Melbourne Hospital /ID# 155095

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 153623

location_facility: Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318

location_facility: St Vincent's Hospital Melbourne /ID# 155094

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095

location_facility: Beth Israel Deaconess Medical Center /ID# 201155

location_facility: Assaf Harofeh Medical Center /ID# 158063

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 153511

location_facility: Duplicate_Regional Oncology Dispensary /ID# 153264

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902

location_facility: Klinicki bolnicki centar Zagreb /ID# 153383

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 153684

location_facility: Sir Charles Gairdner Hospital /ID# 163924

summary:
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.

This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.

In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.


ipd_sharing: No

status: Completed

primary_purpose: Treatment

acronym: ClarIDHy

intervention_type: Drug

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

study_completion_date_type: Actual

lead_sponsor: Agios Pharmaceuticals, Inc.

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Zhu AX, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DVT, Borad MJ, Bridgewater JA, Harris WP, Murphy AG, Oh DY, Whisenant JR, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Chamberlain CX, Aguado-Fraile E, Choe S, Wu B, Liu H, Gliser C, Pandya SS, Valle JW, Abou-Alfa GK. Final Overall Survival Efficacy Results of Ivosidenib for Patients With Advanced Cholangiocarcinoma With IDH1 Mutation: The Phase 3 Randomized Clinical ClarIDHy Trial. JAMA Oncol. 2021 Nov 1;7(11):1669-1677. doi: 10.1001/jamaoncol.2021.3836.

ReferenceCitation: Abou-Alfa GK, Macarulla T, Javle MM, Kelley RK, Lubner SJ, Adeva J, Cleary JM, Catenacci DV, Borad MJ, Bridgewater J, Harris WP, Murphy AG, Oh DY, Whisenant J, Lowery MA, Goyal L, Shroff RT, El-Khoueiry AB, Fan B, Wu B, Chamberlain CX, Jiang L, Gliser C, Pandya SS, Valle JW, Zhu AX. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Jun;21(6):796-807. doi: 10.1016/S1470-2045(20)30157-1. Epub 2020 May 13. Erratum in: Lancet Oncol. 2020 Oct;21(10):e462.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Korea, Republic of
United States
France

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: The Christie NHS Foundation Trust, the Christie Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS Candiolo)

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

location_facility: University of Wisconsin, Carbone Cancer Center

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Hospital Universitario Marques de Valdecilla

summary: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

summary: This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

lead_sponsor: AbbVie

location_country:
Spain
Australia
Canada
Korea, Republic of
United States
France
Japan

location_facility: National Cancer Center Hospital East /ID# 216870

location_facility: National Cancer Center Hospital /ID# 217758

location_facility: University of Texas MD Anderson Cancer Center /ID# 155263

location_facility: Tennessee Oncology-Nashville Centennial /ID# 158654

location_facility: The University of Chicago Medical Center /ID# 155264

location_facility: Virginia Cancer Specialists - Fairfax /ID# 155266

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 200128

location_facility: Massachusetts General Hospital /ID# 155267

location_facility: Hospital Universitario HM Sanchinarro /ID# 200127

location_facility: Hospital Universitario y Politecnico La Fe /ID# 200975

location_facility: Duplicate_Institut Regional du Cancer /ID# 163609

location_facility: Yonsei University Health System Severance Hospital /ID# 166292

location_facility: Seoul National University Hospital /ID# 166291

location_facility: The Angeles Clinic and Researc /ID# 156324

location_facility: Princess Margaret Cancer Centre /ID# 200819

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129

location_facility: Carolina BioOncology Institute /ID# 155265

status_simplified: Ongoing


title: A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

acronym: CheckMate 650

summary: The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).

ReferenceCitation: Sharma P, Pachynski RK, Narayan V, Fléchon A, Gravis G, Galsky MD, Mahammedi H, Patnaik A, Subudhi SK, Ciprotti M, Simsek B, Saci A, Hu Y, Han GC, Fizazi K. Nivolumab Plus Ipilimumab for Metastatic Castration-Resistant Prostate Cancer: Preliminary Analysis of Patients in the CheckMate 650 Trial. Cancer Cell. 2020 Oct 12;38(4):489-499.e3. doi: 10.1016/j.ccell.2020.08.007. Epub 2020 Sep 10.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Canada
United States
France
Germany

location_facility:
Local Institution - 0037
Local Institution - 0047
Local Institution - 0022
Local Institution - 0078
Local Institution - 0036
Local Institution - 0027
Local Institution - 0011
Local Institution - 0061
Local Institution - 0059
Local Institution - 0062
Local Institution - 0005
Local Institution - 0029
Local Institution - 0048
Local Institution - 0010
Local Institution - 0033
Local Institution - 0021
Local Institution - 0051
Local Institution - 0071
Local Institution - 0025
Local Institution - 0003
Local Institution - 0018
Local Institution - 0076
Local Institution - 0042
Local Institution - 0075
Local Institution - 0030
Local Institution - 0038
Local Institution - 0026
Local Institution - 0024
Local Institution - 0034
Local Institution - 0053
Local Institution - 0023
Local Institution - 0028
Local Institution - 0001
Local Institution - 0060
Local Institution - 0054
Local Institution - 0020
Local Institution - 0031
Local Institution - 0065
Local Institution - 0041
Local Institution - 0052
Local Institution - 0019
Local Institution - 0074
Local Institution - 0035
Local Institution
Local Institution - 0046
Local Institution - 0066
Local Institution - 0002
Local Institution - 0043
Local Institution - 0055
Local Institution - 0079
Local Institution - 0063
Local Institution - 0077
Local Institution - 0044
Local Institution - 0009
Local Institution - 0004
Local Institution - 0008
Local Institution - 0032
Local Institution - 0072
Local Institution - 0017
Local Institution - 0067

intervention_type: Biological


title: A Randomized Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma (TAPPAS)

acronym: TAPPAS

summary: This is a study of TRC105 in combination with standard dose pazopanib compared to single agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.

ReferenceCitation: Jones RL, Ravi V, Brohl AS, Chawla S, Ganjoo KN, Italiano A, Attia S, Burgess MA, Thornton K, Cranmer LD, Cheang MCU, Liu L, Robertson L, Adams B, Theuer C, Maki RG. Efficacy and Safety of TRC105 Plus Pazopanib vs Pazopanib Alone for Treatment of Patients With Advanced Angiosarcoma: A Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):740-747. doi: 10.1001/jamaoncol.2021.3547.

ReferenceCitation: Mehta CR, Liu L, Theuer C. An adaptive population enrichment phase III trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS trial). Ann Oncol. 2019 Jan 1;30(1):103-108. doi: 10.1093/annonc/mdy464.

lead_sponsor: Tracon Pharmaceuticals Inc.

location_country:
Poland
Spain
Italy
Austria
United Kingdom
United States
France
Germany

location_facility: Memorial Cancer Center and Institute of Oncology

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


title: 24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)

summary: The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional factor products in the prophylactic treatment of patients with haemophilia A over a 24-month prospective period. Data will also be collected for a 12 month retrospective period.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Oldenburg J, Hay CRM, Jiménez-Yuste V, Peyvandi F, Schved JF, Szamosi J, Winding B, Lethagen S. Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study. BMJ Open. 2019 May 30;9(5):e028012. doi: 10.1136/bmjopen-2018-028012.

ipd_sharing: Undecided

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Spain
Italy
Austria
United Kingdom
Finland
France
Belgium
Norway
Sweden

location_facility:
Swedish Orphan Biovitrum Reserach site
Swedish Orphan Biovitrum Research Site
Swedish Orphan Biovitrum research site
Swedish Orphan Biovitrum Research site


ipd_sharing: Yes

acronym: ENGAGE

title: An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

lead_sponsor: Ipsen

ReferenceCitation: Gracies JM, Francisco GE, Jech R, Khatkova S, Rios CD, Maisonobe P; ENGAGE Study Group. Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis. J Neurol Phys Ther. 2021 Jul 1;45(3):203-213. doi: 10.1097/NPT.0000000000000359.

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
Russian Federation
United States
France
Czechia

location_facility: Fakultní nemocnice Brno Neurologická klinika

location_facility: Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Sébastopol - CHU de Reims

location_facility: Kansas Institute of Research, Kansas City Bone & Joint Clinic, Division of Signature Medical Group of KC

location_facility: Neurology and Physiotherapy Outpatient Clinic

location_facility: Service de Médecine Physique et Réadaptation, CHU Saint Etienne - Hôpital Bellevue

location_facility: Samara Regional Clinical Hospital n.a. V.D.Seredavin

location_facility: Department of Neurology, Division of Movement Disorders, Vanderbilt University

location_facility: University of Pittsburgh Medical Center, Physical Medicine and Rehabilitation

location_facility: Fakultní nemocnice Královské Vinohrady, Neurologická klinika

location_facility: Saint-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Federal Siberian Scientific Clinical Center

location_facility: Service de Médecine Physique et de Réadaptation, Bâtiment Tastet-Girard, Groupe Hospitalier Pellegrin

location_facility: UT Health Physical Medicine & Rehabilitation Department, TIRR Memorial Hermann

location_facility: Neurology Department - Regional Hospital Pardubice

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Albert-Chenevier

summary: The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.


title: Prospective, Multinational, Non-interventional Post-authorisation Study to Document the Long-term Immunogenicity, Safety, and Efficacy of Human-cl rhFVIII (Simoctocog Alfa) in Patients With Haemophilia A Treated in Routine Clinical Practice

summary: Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

lead_sponsor: Octapharma

location_country:
Portugal
Belarus
United Kingdom
Italy
Ecuador
Argentina
Lithuania
Guatemala
United States
France
Norway
Slovakia
Czechia

location_facility: Centro de Tratamiento de la Hemofilia Cordoba

location_facility: AOU Federico II - Dipartimento di Medicina Clinica e Chirurgica

location_facility: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

location_facility: Nottingham University Hospitals NHS Trust

location_facility: A.O. Città della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: L'Azienda Ospedaliero Universitaria Consorziale Policlinico, U.O. di Medicina Trasfusionale, Centro Emofilia e Trombosi

location_facility: UOC Malattie emorragiche e della coagulazione, Azienda Ospedaliera Universitaria Careggi

location_facility: Dipartimento Di Medicina dell'Universita degli Studi di Perugia

location_facility: CTH Centro de Tratamiento de Hematologia y Hemoterapia Córdoba S.A.

location_facility: Gulf States Hemophilia and Thrombophilia

location_facility: U.O.C. Ematologia, Ospedale San Giacomo Apostolo

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia -"Sapienza" Università di Roma

location_facility: Hospital de Especialidades Teodoro Maldonado Carbo

location_facility: Azienda Sanitaria Locale Napoli 1 Centro

location_facility: S.C. Ematologia U, A.O.U. Città della Salute e della Scienza di Torino

location_facility: Vilnius University Hospital, Santariskiu Klinikos-Children's Hospital


type: Other Identifier

title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

enrollment_type: Anticipated

ReferenceCitation: Yap TA, Vieito M, Baldini C, Sepúlveda-Sánchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Löhr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D. First-In-Human Phase I Study of a Next-Generation, Oral, TGFβ Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clin Cancer Res. 2021 Dec 15;27(24):6666-6676. doi: 10.1158/1078-0432.CCR-21-1504. Epub 2021 Sep 21.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
Australia
Canada
Switzerland
United States
France
Japan
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

intervention_type: Radiation


acronym: VIGOR-ALS

title: A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)

lead_sponsor: Cytokinetics

location_country:
Portugal
Spain
Ireland
Italy
Netherlands
United Kingdom
Canada
United States
France
Belgium
Germany

location_facility: George Washington University Medical Center

location_facility: Department of Neurology, Wake Forest School of Medicine

location_facility: Hopital Dupuytren, service de neurologie

location_facility: Charite Campus Virchow-Klinikum, Department of Neurology

location_facility: University of Iowa Hospitals and Clinics

location_facility: Vanderbilt University Medical Center - Clinical Research Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School

location_facility: Clinical Research Centre Beaumont Hospital

location_facility: Montreal Neurological Institute and Hospital

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: Hospital Santa Maria - Centro Hospitalar Lisboa Norte

location_facility: QE II Health Sciences, Nova Scotia Health Authority

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: University of Ulm, Department of Neurology

location_facility: Providence Brain and Spine Inst. ALS Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: UTHSCSA - First Outpatient Research Unit

location_facility: Carol & Frank Morsani Center for Advanced Health Care - University of South Florida

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics

location_facility: Hannover Medical School, Department of Neurology

location_facility: Neurosciences Institute, Neurology - Charlotte

location_facility: University of Miami, Miller School of Medicine

location_facility: St. Louis University, Department of Neurology & Psychiatry

summary: The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).


title: A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

acronym: TOMORROW

summary: This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

status: Recruiting

lead_sponsor: Actelion

location_country:
Spain
Ukraine
United States
South Africa
Philippines
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Mexico
Malaysia
Brazil
Canada
Hungary
China
Finland
Thailand
Vietnam
Korea, Republic of
France
Colombia

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Municipal Institution of Health Care Regional Children's Clinical Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: The Children's Hospital, Zhejiang University school of Medicine

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: General Hospital of Shenyang Military Region

location_facility: Irmandade Da Santa Casa de Misericórdia de São Paulo

location_facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital

location_facility: Beijing Anzhen Hospital of The Capital University of Medical Sciences

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. Meshalkin

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy

location_facility: Columbia University Medical Center - PIN

location_facility: Hôpital Haut-Lévêque - Hôpital cardiologique

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRC

location_facility: GBUZ Children's Hospital named after Bashlyaeva Z.A. Moscow

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of Ukraine

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Schneider Children's Medical Center of Israel - PIN

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

intervention_type: Other


acronym: Sequoia

title: Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

ReferenceCitation: Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

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.

location_country:
Poland
Taiwan
Spain
Italy
Austria
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Belgium
Germany

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Novant Health, Oncology Research Institute

location_facility: Chonnam National University Hwasun Hospital

location_facility: North Shore Hematology Oncology Associates

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: University College London Hospital Foundation Trust

location_facility: Toronto Sunnybrook Regional Cancer Center

location_facility: Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg

location_facility: University of Oklahoma Health Sciences Center

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Texas Oncology-Wichital Falls Texoma Cancer Center

location_facility: University of Massachusetts Medical Center

location_facility: Central Coast Medical Oncology Corporation

location_facility: Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: New England Cancer Specialists - Scarborough

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Hospital Clinico Universitario de Santiago

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Severance Hospital Yonsei University Health System

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH

location_facility: Hospital Universitario Germans Trias i Pujol

summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.


title: Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

summary: The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
Italy
Canada
United States
France
Israel
Belgium
Singapore

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center SC-3


title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

summary: The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

location_country:
Taiwan
Hong Kong
Spain
Canada
Korea, Republic of
United States
France
China
Japan
Singapore

location_facility: Baylor Scott and White Research Institute

location_facility: University of Utah - Huntsman Cancer Institute - PPDS


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene

summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.

lead_sponsor: Arog Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
United States
France
Norway
Germany

location_facility: Mannheim University Medical Centre, University of Heidelberg

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology

location_facility: University Hospital The Norwegian Radium Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Reims


acronym: DISCOVER

title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

lead_sponsor: Gilead Sciences

publications_result: Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.

ReferenceType: result

ReferenceCitation: Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5.

ReferenceCitation: Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD; DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2021 Jul;8(7):e397-e407. doi: 10.1016/S2352-3018(21)00071-0. Erratum in: Lancet HIV. 2021 Dec;8(12):e734.

ReferenceCitation: Glidden DV, Das M, Dunn DT, Ebrahimi R, Zhao Y, Stirrup OT, Baeten JM, Anderson PL. Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. J Int AIDS Soc. 2021 May;24(5):e25744. doi: 10.1002/jia2.25744.

location_country:
Denmark
Spain
Ireland
Austria
Italy
Netherlands
Canada
United Kingdom
United States
France
Germany

summary: The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.


title: Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome

summary: Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

ReferenceCitation: Pane F, Lefevre G, Kwon N, Bentley JH, Yancey SW, Steinfeld J. Characterization of disease flares and impact of mepolizumab in patients with hypereosinophilic syndrome. Front Immunol. 2022 Aug 26;13:935996. doi: 10.3389/fimmu.2022.935996. eCollection 2022.

ReferenceCitation: Rothenberg ME, Roufosse F, Faguer S, Gleich GJ, Steinfeld J, Yancey SW, Mavropoulou E, Kwon N; HES Mepolizumab Study Group. Mepolizumab Reduces Hypereosinophilic Syndrome Flares Irrespective of Blood Eosinophil Count and Interleukin-5. J Allergy Clin Immunol Pract. 2022 Sep;10(9):2367-2374.e3. doi: 10.1016/j.jaip.2022.04.037. Epub 2022 May 12.

ReferenceCitation: Reiter A, Lefevre G, Cid MC, Kwon N, Mavropolou E, Yancey SW, Steinfeld J. Association Between Baseline Therapy and Flare Reduction in Mepolizumab-Treated Patients With Hypereosinophilic Syndrome. Front Immunol. 2022 Apr 13;13:840974. doi: 10.3389/fimmu.2022.840974. eCollection 2022.

ReferenceCitation: Gleich GJ, Roufosse F, Chupp G, Faguer S, Walz B, Reiter A, Yancey SW, Bentley JH, Steinfeld J; HES Mepolizumab Study Group. Safety and Efficacy of Mepolizumab in Hypereosinophilic Syndrome: An Open-Label Extension Study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4431-4440.e1. doi: 10.1016/j.jaip.2021.07.050. Epub 2021 Aug 10.

ReferenceCitation: Roufosse F, Kahn JE, Rothenberg ME, Wardlaw AJ, Klion AD, Kirby SY, Gilson MJ, Bentley JH, Bradford ES, Yancey SW, Steinfeld J, Gleich GJ; HES Mepolizumab study group. Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Dec;146(6):1397-1405. doi: 10.1016/j.jaci.2020.08.037. Epub 2020 Sep 18.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
Romania
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
France
United States
Belgium
Germany


title: An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

lead_sponsor: H3 Biomedicine Inc.

location_country:
Taiwan
Spain
Italy
Russian Federation
United Kingdom
Canada
Korea, Republic of
United States
France
Belgium
Singapore

location_facility: Georgetown Unversity Lombardi Comprehensive Cancer Center

location_facility: Sarah Cannon Research Institute UK - SCRI - PPDS

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: John theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Cincinnati Cancer Institute

location_facility: START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Modena

location_facility: University of Texas Southwestern Medical Center

location_facility: IRCCS Ospedale San Raffaele S.r.l. - PPDS

location_facility: IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica

location_facility: University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine

location_facility: Hospital Universitario Marques de Valdecilla


acronym: ASCLEPIOS I

title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

ReferenceCitation: Gärtner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Häring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.

ReferenceCitation: Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Estonia
Thailand
France
Netherlands

summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis


type: Registry Identifier

title: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

acronym: EARNEST

summary: The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Charite Universitatsmedizin Berlin -Campus Virchow Klinikum

location_facility: University of Utah Health Sciences Center

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum


title: A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)

acronym: EFFECT

summary:
The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

time_perspective: Retrospective

ReferenceCitation: Min J, Cohan S, Alvarez E, Sloane J, Phillips JT, van der Walt A, Koulinska I, Fang F, Miller C, Chan A. Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 31.

lead_sponsor: Biogen

location_country:
Croatia
Spain
Italy
United Kingdom
Australia
Argentina
Canada
Czech Republic
Switzerland
Hungary
United States
France
Germany


title: A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.

ReferenceCitation: Mansfield AS, Każarnowicz A, Karaseva N, Sánchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.

ReferenceCitation: Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.

ReferenceCitation: Horn L, Mansfield AS, Szczęsna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Mexico
Brazil
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Chile

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Harbin Medical University Cancer Hospital

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Kurashiki Central Hospital; Respiratory Medicine

location_facility: University Hospital Kyoto Prefectural University of Medicine, Pulmonary Medicine

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: University Hospital of Patras Medical Oncology

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: Clinical Center Nis; Clinic for pulmonary diseases

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: Cancer Treatment Centers of America - Midwestern Regional Medical Center

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

location_facility: Hopital Calmette; Pneumologie Oncologie Ouest

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: National Hospital Organization Himeji Medical Center

summary: This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.


title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

location_country:
Italy
Australia
Netherlands
Canada
United States
France
Germany

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Klinikum rechts der Isar der Technischen Universitat Muenchen Klinik und Poliklinik fur Innere Mediz

location_facility: Columbia University Medical Center (Cumc)

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale


title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

ReferenceCitation: Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)pico linonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19.

location_country:
Spain
Greece
United Kingdom
Netherlands
Ukraine
Korea, Republic of
United States
France
Turkey
Germany

location_facility: The Center for Cancer and Blood Disorders

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Florida Cancer Specialists and Research Institute


title: A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors

summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

location_country:
Spain
Italy
Australia
Canada
United States
France
China
Japan
Netherlands


title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi

lead_sponsor: Parion Sciences

location_country:
Ireland
United States
United Kingdom
France

summary: The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

ReferenceCitation: Dörner T, Tanaka Y, Dow ER, Koch AE, Silk M, Ross Terres JA, Sims JT, Sun Z, de la Torre I, Petri M. Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus. Ann Rheum Dis. 2022 May 24. pii: annrheumdis-2022-222335. doi: 10.1136/annrheumdis-2022-222335. [Epub ahead of print]

ReferenceCitation: Dörner T, van Vollenhoven RF, Doria A, Jia B, Ross Terres JA, Silk ME, de Bono S, Fischer P, Wallace DJ. Baricitinib decreases anti-dsDNA in patients with systemic lupus erythematosus: results from a phase II double-blind, randomized, placebo-controlled trial. Arthritis Res Ther. 2022 May 16;24(1):112. doi: 10.1186/s13075-022-02794-x.

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:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dörner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1. Erratum in: Lancet. 2018 Aug 11;392(10146):476.

location_country:
Poland
Taiwan
Romania
Spain
Austria
Argentina
Korea, Republic of
United States
France
Puerto Rico
Mexico
Japan

location_facility: Louisiana State University Health Sciences Center

location_facility: West Broward Rheumatology Associates, Inc

location_facility: Meguro-kuFor additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: North Shore University Hospital at Great Neck

location_facility: The Oklahoma Center For Arthritis Therapy

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Accent Clinical Research Professionals, LLC

location_facility: Clinical Research Center of Reading, LLC

summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

location_country:
Poland
Portugal
United Kingdom
United States
France
Germany

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

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

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital

location_facility: Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: University Hospitals Birmingham NHS Foundation Trust

summary: This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).


title: Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia

acronym: TANGO

summary: The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

status: Terminated

ipd_sharing_description: To be determined

lead_sponsor: Cerenis Therapeutics, SA

location_country:
Italy
Canada
United States
France
Israel
Belgium
Netherlands

status_simplified: Unknown


title: A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis

acronym: AURIEL-PsO

summary: The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

lead_sponsor: Fresenius Kabi SwissBioSim GmbH

location_country:
Poland
United Kingdom
Russian Federation
Estonia
Canada
Hungary
United States
France
Mexico
Germany
Bulgaria
Czechia

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: Praxis fuer Dermatologie und Venerologie

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Florida Academic Centers Research and Education

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque

location_facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem

location_facility: Dr Melinda Gooderham Medicine Professional Corporation

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Ambrozia Gondozohaz Szolg. Nonprofit Kft.

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: LLC "Alliance Biomedical - Russian Group"

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

location_facility: SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Dermatology Treatment and Research Center

location_facility: Unidad de Investigacion de las Enfermedades Reumaticas

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: San Luis Dermatology & Laser Clinic, Inc.

location_facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska


title: Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days

acronym: CLARINET FORTE

summary: This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

location_country:
Denmark
Poland
Spain
Ireland
Italy
Netherlands
United Kingdom
France
Belgium
Germany

location_facility: The Christie Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Hospital Universitario Central de Asturias

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5

location_facility: Università degli Studi "Federico II" di Napoli

location_facility: Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: Fondacione IRCCS Istituto Nazionale Dei Tumori


title: A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

acronym: STARTRK-NG

summary: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

ReferenceCitation: Desai AV, Robinson GW, Gauvain K, Basu EM, Macy ME, Maese L, Whipple NS, Sabnis AJ, Foster JH, Shusterman S, Yoon J, Weiss BD, Abdelbaki MS, Armstrong AE, Cash T, Pratilas CA, Corradini N, Marshall LV, Farid-Kapadia M, Chohan S, Devlin C, Meneses-Lorente G, Cardenas A, Hutchinson KE, Bergthold G, Caron H, Chow Maneval E, Gajjar A, Fox E. Entrectinib in children and young adults with solid or primary CNS tumors harboring NTRK, ROS1, or ALK aberrations (STARTRK-NG). Neuro Oncol. 2022 Oct 3;24(10):1776-1789. doi: 10.1093/neuonc/noac087.

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

location_country:
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
China
Germany

location_facility: Institut Gustave Roussy; Service de Pathologie Morphologique

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Children's National Medical Center; Department of Pediatrics

location_facility: Morgan Stanley Children's Hospital; Herbert Irving Cancer Center

location_facility: Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

location_facility: University of Minnesota Childrens' Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Texas Children's Cancer and Hematology Center

location_facility: UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology

location_facility: A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM

location_facility: Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

location_facility: University of Chicago; Comer Children's Hospital/Department of Pediatrics

location_facility: Children's Hospital Colorado; Center For Cancer/Blood Disorder

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

location_facility: Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology

location_facility: Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder

location_facility: Hopital Purpan; Pediatrie - Hematologie - Oncologie pediatrique

location_facility: Memorial Sloan Kettering Cancer Center; Pediatrics

location_facility: Nationwide Children's Hospital; Dept. of Pulmonology

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: National Taiwan University Hospital; Department of Paediatrics


title: Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Austria
Netherlands
Russian Federation
Argentina
Canada
Korea, Republic of
United States
France
South Africa
Mexico
Japan
Germany

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Advanced Rheumatology & Arthritis Research Center, P.C

location_facility: Unidad Reumatologica Las Americas, S.C. P.

location_facility: Universitaetsklinik Fuer Innere Medizin 3

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Centrum Badan Klinicznych JCI Life Science Park

location_facility: Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

summary: The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.


title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Drisapersen in Subjects With Duchenne Muscular Dystrophy.

summary: This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

status: No longer available

study_type: Expanded Access

lead_sponsor: BioMarin Pharmaceutical

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
United Kingdom
Korea, Republic of
United States
France
Israel
Norway
Belgium
Japan
Germany
Turkey
Bulgaria
Czechia

location_facility: Royal Children's Hosital, Children's Neuroscience Centre

location_facility: Universitair Ziekenhuis Gent, Afdeling Neurologie

location_facility: Hôpital de La Citadelle, Centre de référence des Maladies

location_facility: National Center Hospital of Neurology and Psychiatry

location_facility: IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Seoul National University Children's Hospital

location_facility: Queen Fabiola Children's University Hospital

location_facility: Hadassah, Hebrew University Medical Center


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction

acronym: PRONTO

summary: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Spain
Greece
Austria
Australia
Italy
United Kingdom
United States
France
Israel
Germany

location_facility: The University of Queensland - Princess Alexandra Hospital (PAH)

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center - Froedtert Hospital

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital


title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

lead_sponsor: Kite, A Gilead Company

location_country:
Poland
Spain
Italy
Netherlands
Canada
Sweden
France
United States
Belgium
Germany
Czechia

location_facility: University Medical Center Hamburg-Eppendorf (UKE)

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Unité d'Oncologie et Hématologie Pédiatriques

location_facility: Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP

location_facility: Monroe-Carell Jr. Children's Hospital at Vanderbilt

location_facility: Hopital Robert Debre - Sevice d'Hemato-immunologic

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: University of Virginia Health System, Pediatric Hematology/Oncology Clinic

location_facility: Jurasz University Hospital 1; Collegium Medicum

location_facility: Institut d'Hematologie et Oncologie Pediatrique

location_facility: Ann & Robert H. Lurie Children's Hospital

summary: The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).


acronym: HAVEN 1

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

ReferenceCitation: Kruse-Jarres R, Peyvandi F, Oldenburg J, Chang T, Chebon S, Doral MY, Croteau SE, Lambert T, Kempton CL, Pipe SW, Ko RH, Trzaskoma B, Dhalluin C, Bienz NS, Niggli M, Lehle M, Paz-Priel I, Young G, Jiménez-Yuste V. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood Adv. 2022 Aug 8. pii: bloodadvances.2022007458. doi: 10.1182/bloodadvances.2022007458. [Epub ahead of print]

ReferenceCitation: Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
New Zealand
Korea, Republic of
United States
Costa Rica
France
South Africa
Japan
Germany

location_facility: Pennsylvania State Hershey Medical Center; Division of Hematology/Oncology, H046

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: Royal Prince Alfred Hospital; Haematology

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

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

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Oregon Health & Science Uni ; Dept of Pediatrics

location_facility: Auckland City Hospital; Auckland Haemophilia Centre

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: St Thomas' Hospital; Haemostasis & Thromboisis Centre

location_facility: Univ of TX Health Science Ctr; Gulf States Hemo and Throm Ctr

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Cornell Univ Medical College; Hematology-Oncolog

location_facility: CTC North GmbH & Co. KG am Universitätsklinikum Hamburg-Eppendorf

summary: This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).


title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

ReferenceCitation: Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum in: BMC Neurol. 2020 Mar 13;20(1):90.

ReferenceCitation: Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

ReferenceCitation: Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ, Stauffer VL. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.

location_country:
Canada
Hungary
Puerto Rico
United States
France
Belgium

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Jacksonville Center for Clinical Research

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: New England Institute for Clinical Research

summary: The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.