lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Austria
Brazil
France
Israel
Norway
Australia
Spain
United States
United Kingdom
Korea, Republic of

acronym: Phase 2 Study in 1L HNSCC of IT MK-1454 / MK-3475 IV vs MK-3475 IV

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0058)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0014)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 0032)

location_facility: Haukeland Universitetssykehus, Klinisk forskningspost voksne ( Site 0086)

location_facility: Allgemeines Krankenhaus der Stadt Wien ( Site 0049)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0085)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0115)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0031)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0078)

location_facility: Hospital de Caridade de Ijui ( Site 0061)

location_facility: Hospital Clinico de Barcelona ( Site 0116)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0064)

location_facility: Centro Regional Integrado de Oncologia ( Site 0062)

location_facility: Monash Health-Monash Medical Centre ( Site 0041)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0114)

location_facility: University of California at San Francisco ( Site 0006)

location_facility: Calvary Central Districts Hospital ( Site 0042)

title: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy

summary:
The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag in PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone:

in participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and
in participants with a tumor that has a PD-L1 CPS ≥ 20.


type: EudraCT Number

title: A Phase 1/2 Single-arm Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan in Children With Refractory or Recurrent Solid Tumors

summary:
The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding central nervous system [CNS] tumors).

The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eisai Inc.

location_country:
Italy
Switzerland
Poland
France
Greece
Spain
Germany
United Kingdom

location_facility: Istituto G Gaslini Ospedale Pediatrico IRCCS

location_facility: The Leeds Teaching Hospitals Charitable Foundation - Leeds Childrens Hospital (LCH)

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Aghia Sophia' Children's General Hospital of Athens

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: AHEPA University General Hospital of Thessaloniki

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

sequence: first

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

sequence: additional

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

given: Gregory

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

design_allocation: Randomized

status: Recruiting

enrollment_type: Anticipated

location_country:
Italy
Brazil
United States
Peru
Mexico
Spain
Germany
France
Japan
Poland
Hungary
Australia
Russian Federation
China
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)

location_facility: University of Connecticut Health Center ( Site 0020)

location_facility: Fudan University Shanghai Cancer Center ( Site 3324)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 2703)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

location_facility: Medical Park Izmir Hospital ( Site 2807)

location_facility: Universitaetsklinikum Koeln ( Site 2111)

location_facility: Universitaetsklinikum Regensburg ( Site 2100)

location_facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)

location_facility: Taunton and Somerset Hospital ( Site 2900)

location_facility: University of Kansas Cancer Center ( Site 0033)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)

location_facility: McGill University Health Centre ( Site 0206)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)

location_facility: National Cancer Center Hospital ( Site 1102)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2206)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)

location_facility: Altay Regional Oncology Dispensary ( Site 2611)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0204)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Dana Farber Cancer Institute ( Site 0019)

location_facility: Hospital Universitario 12 de Octubre ( Site 2702)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)

location_facility: Royal Marsden NHS Foundation Trust ( Site 2910)

location_facility: Chonnam National University Hwasun Hospital ( Site 1202)

location_facility: National Taiwan University Hospital ( Site 1600)

location_facility: Fundacao Sao Francisco Xavier ( Site 0409)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0607)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1101)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0045)

location_facility: California Cancer Associates for Research & Excellence ( Site 0059)

location_facility: Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

location_facility: The Third Affiliated Hospital of Harbin Medical University ( Site 3302)

location_facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)

location_facility: University of Colorado Cancer Center ( Site 0023)

location_facility: California Cancer Associates for Research & Excellence ( Site 0025)

location_facility: Universitaetsklinikum Frankfurt ( Site 2107)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)

location_facility: University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0703)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)

location_facility: Aichi Cancer Center Hospital ( Site 1113)

location_facility: Taipei Veterans General Hospital ( Site 1601)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2801)

location_facility: University of North Carolina- Chapel Hill ( Site 0056)

location_facility: National Cheng Kung University Hospital ( Site 1603)

location_facility: Hiroshima University Hospital ( Site 1109)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)

location_facility: Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)

location_facility: Wuhan Union hospital Cancer Center ( Site 3307)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0028)

location_facility: Xiangya Hospital of Central South University ( Site 3305)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)

location_facility: SUNY Upstate Medical University ( Site 0051)

location_facility: Orszagos Onkologiai Intezet ( Site 2202)

location_facility: Georgia Cancer Center at Augusta University ( Site 0013)

location_facility: Yokohama City University Hospital ( Site 1104)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)

location_facility: Peking Union Medical College Hospital ( Site 3304)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)

location_facility: ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)

location_facility: IEO Istituto Europeo di Oncologia ( Site 2406)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)

location_facility: St. Vincent Frontier Cancer Center ( Site 0008)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 2805)

location_facility: West China Hospital of Sichuan University ( Site 3308)

location_facility: Keimyung University Dongsan Hospital ( Site 1203)

location_facility: Fujian Provincial Cancer Hospital ( Site 3326)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 2507)

location_facility: Medipol Universite Hastanesi ( Site 2800)

location_facility: Washington University School of Medicine ( Site 0060)

location_facility: Hospital Universitario La Paz ( Site 2706)

location_facility: ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1103)

location_facility: Princess Margaret Cancer Centre ( Site 0200)

location_facility: Providence Portland Medical Center ( Site 0048)

location_facility: National Cancer Center Hospital East ( Site 1100)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)

location_facility: Universitaetsklinikum Tuebingen ( Site 2108)

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)

location_facility: Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)

location_facility: Inova Schar Cancer Institute ( Site 0009)

location_facility: Seoul National University Bundang Hospital ( Site 1205)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site

location_facility: Tianjin Medical University Cancer Hospital ( Site 3312)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 1111)

location_facility: Christie NHS Foundation Trust ( Site 2903)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0603)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0704)

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

summary:
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).

status_simplified: Ongoing


status: Active, not recruiting

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 and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Finland
Malaysia
Australia
Taiwan
Ukraine
Croatia
France
Poland
Norway
Canada
Netherlands
Singapore
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Czechia
Israel
New Zealand
Spain

acronym: Heads UP

location_facility: Beacon Clinical Research, LLC /ID# 218636

location_facility: Dermoklinika Centrum Medyczne s.c. /ID# 214300

location_facility: Kyiv City Clinical Skin and Venereal Hospital /ID# 218382

location_facility: Clinical Research Partners, LLC /ID# 218480

location_facility: Hospital Pakar Sultanah Fatimah /ID# 218877

location_facility: Medical University of South Carolina /ID# 221072

location_facility: Oregon Health and Science University /ID# 218578

location_facility: University Hospitals Case Medical Center /ID# 218574

location_facility: Sneeze, Wheeze, & Itch Associates, LLC /ID# 218552

location_facility: AP-HM - Hopital de la Timone /ID# 218957

location_facility: Royalderm Agnieszka Nawrocka /ID# 214302

location_facility: Hospital Universitario de Bellvitge /ID# 214257

location_facility: Dermatology Research Associates /ID# 218637

location_facility: Klinicki bolnicki centar Zagreb /ID# 218375

location_facility: Nemocnice Jihlava, prispevkova organizace /ID# 214178

location_facility: California Allergy and Asthma Medical Group /ID# 218635

location_facility: Wellington Regional Hospital /ID# 218689

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 218385

location_facility: Taipei Municipal Wan Fang Hospital /ID# 218918

location_facility: ClinicMed Daniluk, Nowak Sp.j. /ID# 214299

location_facility: Niakosari Medicine Professional Corporation /ID# 218729

location_facility: Hospital Universitario Dr. Negrin /ID# 214256

location_facility: Clinical Research Trials of Florida, Inc. /ID# 218438

location_facility: Miami Dermatology and Laser Institute /ID# 218664

location_facility: Keski-pohjanmaa Central Hospital /ID# 214630

location_facility: Universitatsklinikum Munster /ID# 214222

location_facility: DermaPlus - Poliklinika za dermatologiju i venerologiju /ID# 218377

location_facility: Medical Dermatology Associates of Chicago /ID# 218551

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 218725

location_facility: Fakultni nemocnice Hradec Kralove /ID# 214176

location_facility: Clinical Research Solutions, LLC /ID# 218447

location_facility: The Royal Free London NHS Foundation Trust /ID# 213560

location_facility: Allergy, Asthma & Immunology Associates, PC /ID# 218548

location_facility: Universitetssykehuset N-Norge, Tromso /ID# 214634

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 218724

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 214096

location_facility: Oregon Medical Res Center PC /ID# 218440

location_facility: Naftalan - Specijalna bolnica za medicinsku rehabilitaciju /ID# 218376

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 214225

location_facility: National Taiwan University Hospital /ID# 218917

location_facility: University of Arkansas for Medical Sciences /ID# 221021

location_facility: Chung Shan Medical University /ID# 218919

location_facility: Universitaetsklinikum Frankfurt /ID# 214223

location_facility: Florida International Rsrch cr /ID# 218663

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214095

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 218959

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 214301

location_facility: Medizinische Hochschule Hannover /ID# 214226

location_facility: Oulun yliopistollinen sairaala /ID# 214628

location_facility: Dermatology Research Institute Inc. /ID# 218728

location_facility: Hospital Universitario Arnau Vilanova /ID# 214254

location_facility: National University Hospital /ID# 219093

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 218879

location_facility: Georgia Pollens Clinical Research Centers, Inc /ID# 218441

location_facility: St Vincent's University Hospital /ID# 213558

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 214221

location_facility: Universitair Medisch Centrum Utrecht /ID# 218771

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 214984

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 214255

location_facility: Universitair Medisch Centrum Groningen /ID# 218775

location_facility: China Medical University Hosp /ID# 218409

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 218722

location_facility: Michigan Center for Research Company /ID# 218577

location_facility: Hospital Universitario y Politecnico La Fe /ID# 214252

location_facility: NHS Greater Glasgow and Clyde /ID# 213561

location_facility: University Hospitals Sussex NHS Foundation Trust /ID# 213562

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 214093

location_facility: CHU Toulouse - Hopital Larrey /ID# 218958

location_facility: Holdsworth House Medical Practice /ID# 218755

title: A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046

summary:
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.

Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.


lead_sponsor: Bristol-Myers Squibb

location_country:
Mexico
Netherlands
Germany
France
Poland
Belgium
Argentina
Spain
United States
United Kingdom

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Joint Muscle Medical Care and Research Institute - Lilington Office

location_facility: Hospital Central Doctor Ignacio Morones Prieto

location_facility: Clinical Investigation Specialists - Gurnee

location_facility: North Georgia Rheumatology Group-Lawrenceville

location_facility: Medvin Clinical Research - Covina Office

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Universitair Ziekenhuis Leuven Multidisciplinair Borstcentrum

location_facility: Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno

location_facility: Klinikum der Ludwig Maximillians Universitat Munchen

location_facility: Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz

location_facility: Precision Comprehensive Clinical Research Solutions

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

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

location_facility: Arthritis and Osteoporosis Center - Orangeburg

location_facility: Medycyna Kliniczna Marzena Waszczak - Jeka

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Inland Rheumatology and Osteoporosis Medical Group

location_facility: Arizona Arthritis and Rheumatology Research

location_facility: Guys and Saint Thomas NHS Foundation Trust

title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

summary: The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).


title: A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis

acronym: BANFF

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).

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

lead_sponsor: Genentech, Inc.

location_country:
France
Puerto Rico
Belgium
Spain
United States

location_facility: Hunter Holmes McGuire V.A. Medical Center

location_facility: Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)

location_facility: Duke Medical Center; Gen Clinic Research Ctr

location_facility: Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department

location_facility: Hospital Universitario Vall d Hebron; servicio de oftalmologia

location_facility: UC San Diego Airway Research and Clinical Trials Center

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Pinnacle Clinical Research - San Antonio

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: National Research Institute - Panorama City

location_facility: Texas Digetive Disease Consultants - Austin

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Consorci Hospital General Universitari de València

location_facility: Hôpital d'Enfants, Service d'onco-hématologie pédiatrique


title: Safety Study of Oral Edaravone Administered in Subjects With ALS

summary: The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

ipd_sharing: Undecided

lead_sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

location_country:
Italy
United States
France
Japan
Germany
Canada

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: National Hospital Organization Chiba-East-Hospital

location_facility: University of Colorado Anschutz Medical Campus

location_facility: National Hospital Organization Toneyama Medical Center

location_facility: University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: Shiga University of Medical Science Hospital

location_facility: University of Michigan - ALS Center of Excellence

location_facility: National Hospital Organization Iou National Hospital

location_facility: Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

location_facility: Niigata University Medical And Dental Hospital

location_facility: Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: Houston Methodist Neurological Institute

location_facility: University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: Montreal Neurological Institute and Hospital

location_facility: National Hospital Organization Kumamoto Saishun Medical Center

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques

location_facility: Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

location_facility: National Hospital Organization Utano Hospital

location_facility: Heritage Medical Research Clinic - University Of Calgary


ReferenceCitation: McNamara MG, Goyal L, Doherty M, Springfeld C, Cosgrove D, Sjoquist KM, Park JO, Verdaguer H, Braconi C, Ross PJ, Gramont A, Zalcberg JR, Palmer DH, Valle JW, Knox JJ. NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). Future Oncol. 2020 Jun;16(16):1069-1081. doi: 10.2217/fon-2020-0247. Epub 2020 May 6.

name: Division of Cancer Sciences, The University of Manchester & The Christie NHS Foundation Trust, Manchester, M20 4BX, UK

family: McNamara

full_name: Mairéad Geraldine McNamara

given: Mairéad Geraldine

name: Department of Medical Oncology, Massachusetts General Hospital, Boston, MA 02114, USA

family: Goyal

full_name: Lipika Goyal

given: Lipika

name: Department of Medical Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, M4Y 1H1, Canada

family: Doherty

full_name: Mark Doherty

given: Mark

name: Heidelberg University Hospital, Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany

family: Springfeld

full_name: Christoph Springfeld

given: Christoph

name: Department of Medical Oncology, Sidney Kimmel Comp Cancer Center, The Johns Hopkins Hospital, Baltimore, MD 21287, USA

family: Cosgrove

full_name: David Cosgrove

given: David

name: NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia

family: Sjoquist

full_name: Katrin Marie Sjoquist

given: Katrin Marie

name: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of (South) Korea

family: Park

full_name: Joon Oh Park

given: Joon Oh

name: Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain

family: Verdaguer

full_name: Helena Verdaguer

given: Helena

name: The University of Glasgow & the Beatson West of Scotland Cancer Centre, Glasgow, UK

family: Braconi

full_name: Chiara Braconi

given: Chiara

name: Department of Medical Oncology, Guy's Hospital, London, UK

family: Ross

full_name: Paul J Ross

given: Paul J

name: Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France

family: Gramont

full_name: Aimery De Gramont

given: Aimery De

name: Department of Medical Oncology, Alfred Health & School of Public Health, Monash University, Melbourne, Australia

family: Zalcberg

full_name: John Raymond Zalcberg

given: John Raymond

name: Department of Medical Oncology, University of Liverpool, Liverpool, UK

family: Palmer

full_name: Daniel H Palmer

given: Daniel H

family: Valle

full_name: Juan W Valle

given: Juan W

name: Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada

family: Knox

full_name: Jennifer J Knox

given: Jennifer J

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

lead_sponsor: NuCana plc

location_country:
Italy
United States
Germany
France
Czechia
Hungary
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Centro Ricerche Cliniche di Verona S.r.l

location_facility: Hospital Universitario Clinico San Carlos

location_facility: CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Northwest Cancer Specialists, P.C.-Vancouver

location_facility: Rocky Mountain Cancer Centers, LLP- Aurora

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: State Budget Institution of Healthcare "Leningrad Regional Clinical Oncology Dispensary"

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Communal Institution Odesa Regional Clinical Hospital

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Chonnam National University Hwasun Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: The Oncology Institute of Hope and Innovation

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Seoul National University Bundang Hospital

location_facility: The Research Foundation for The State University of New York

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: Treatment-Prevention Institution Volyn Regional Oncological Dispensary

location_facility: Baskent University Adana Application and Research Center

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: University of Rochester Medical Center - Strong Memorial Hospital

location_facility: SI "Shalimov's National Institute of Surgery and Transplantation" of NAMSU

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

ipd_sharing: No

title: A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

summary:
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care


intervention_type: Other

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.

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Poland
Lithuania
Australia
Spain
Estonia
Canada
Latvia
Korea, Republic of

location_facility: California Dermatology & Clinical Research Institute

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

location_facility: Hallym University Kangnam Sacred Heart Hospital

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

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

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros klinikos

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Sant Joan de Deu Serveis En Salut Mental

location_facility: Health Center 4, Affiliate Diagnostic Center

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Specjalistyczny Osrodek Alergologiczno-Internistyczny ALL-ME

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Smite Aija - Practice in Dermatology Venereology

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Soon Chun Hyang University Seoul Hospital

title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

summary: This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


title: A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN)

acronym: M-PLACE

summary: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

lead_sponsor: MorphoSys AG

location_country:
Italy
Netherlands
France
Poland
Belgium
Australia
Spain
United States
Korea, Republic of

location_facility: Hallym University Kangdong Sacred Heart Hospital

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Hospital General Universitario de Valencia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The Ohio State University Wexner Medical Center

location_facility: Kidney Care and Transplant Services of New England, PC

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: University of Miami Division of Nephrology & Hypertension


title: Phase II, Single Arm, Non-randomized and Multicenter Clinical Trial of Regorafenib as a Single Agent in the First-line Setting for Patients With Metastatic and/or Unresectable KIT/PDGFR Wild Type GIST

acronym: REGISTRI

summary: Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable KIT/PDGFR wild type GIST in the first line setting.

lead_sponsor: Grupo Espanol de Investigacion en Sarcomas

location_country: Italy France Spain

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Fondazione IRCCS Istituto Dei Tumori di Milano


ReferenceType: result

ReferenceCitation: Juarez M, Diaz N, Johnston GI, Nayar S, Payne A, Helmer E, Cain D, Williams P, Devauchelle-Pensec V, Fisher BA, Giacomelli R, Gottenberg JE, Guggino G, Kvarnström M, Mariette X, Ng WF, Rosas J, Sánchez Bursón J, Triolo G, Barone F, Bowman SJ. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren's syndrome. Rheumatology (Oxford). 2021 Mar 2;60(3):1364-1375. doi: 10.1093/rheumatology/keaa410.

name: Translational Medicine, UCB Pharma, Slough, UK

family: Juarez

full_name: Maria Juarez

given: Maria

family: Diaz

full_name: Nieves Diaz

given: Nieves

family: Johnston

full_name: Geoffrey I Johnston

given: Geoffrey I

family: Nayar

full_name: Saba Nayar

given: Saba

family: Payne

full_name: Andrew Payne

given: Andrew

name: Quantitative Clinical Pharmacology, Slough, UK

family: Helmer

full_name: Eric Helmer

given: Eric

name: Global Clinical Sciences and Operations, UCB Pharma, Slough, UK

family: Cain

full_name: Dionne Cain

given: Dionne

name: Statistical Science and Innovation, UCB Pharma, Raleigh, NC, USA

family: Williams

full_name: Paulette Williams

given: Paulette

name: Department of Rheumatology, Brest University, Cavale Blanche Hospital, Brest, France

family: Devauchelle-Pensec

full_name: Valerie Devauchelle-Pensec

given: Valerie

name: National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

name: Rheumatology Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK

family: Fisher

full_name: Benjamin A Fisher

given: Benjamin A

name: Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L’Aquila, Italy

family: Giacomelli

full_name: Roberto Giacomelli

given: Roberto

name: Department of Rheumatology, National Reference Centre For Rare Systemic Auto-Immune Diseases, Strasbourg University Hospital, University of Strasbourg, IBMC, CNRS UPR 3572, Strasbourg, France

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

name: Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, Rheumatology Section, University of Palermo, Palermo, Italy

family: Guggino

full_name: Giuliana Guggino

given: Giuliana

name: Department of Medicine, Rheumatology Unit, Karolinska Institutet, Stockholm, Sweden

family: Kvarnström

full_name: Marika Kvarnström

given: Marika

name: Université Paris-Saclay, INSERM, CEA, Centre de recherche en Immunologie des Infections Virales et des Maladies auto-Immunes, AP-HP.Université Paris-Saclay, Hôpital Bicêtre, Rheumatology Department, Le Kremlin Bicêtre, France

family: Mariette

full_name: Xavier Mariette

given: Xavier

name: Translational and Clinical Research Institute, Newcastle University & NIHR Newcastle Biomedical Research Centre, Newcastle upon Tyne, UK

family: Ng

full_name: Wan Fai Ng

given: Wan Fai

name: Department of Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain

family: Rosas

full_name: José Rosas

given: José

name: Department of Rheumatology, Infanta Luisa Hospital, Sevilla, Spain

family: Sánchez Bursón

full_name: Juan Sánchez Bursón

given: Juan

family: Triolo

full_name: Giovanni Triolo

given: Giovanni

family: Barone

full_name: Francesca Barone

given: Francesca

family: Bowman

full_name: Simon J Bowman

given: Simon J

journal_name: Rheumatology

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

title: A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjögren’s syndrome

location_country:
Italy
Sweden
France
Spain
United Kingdom

title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome

summary:
This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS).

The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.


title: A Dose Escalation Study to Evaluate Safety, Tolerability Dosimetry, Pharmacokinetics and Preliminary Efficacy of 131I-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients

acronym: Tenatumomab

summary: Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was studied on a commercial tissue array slides each carrying malignant breast, colorectal, lung, ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type showed positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is exploring the use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.

status: Terminated

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Italy France

location_facility: Istituto Nazionale Dei Tumori Irccs - Fondazione "G. Pascale"

intervention_type: Combination Product

status_simplified: Unknown


title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

acronym: RAISE

summary: The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.

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

lead_sponsor: Ra Pharmaceuticals

location_country:
Italy
United States
France
Japan
Poland
Norway
Spain
Germany
United Kingdom
Canada

location_facility: Site 204: Centre Hospitalier Régional Universitaire de Lille

location_facility: Site 137: Les Hôpitaux Universitaires de Strasbourg

location_facility: Site 209: Niepubliczny Zakład Opieki Zdrowotnej NEURO - KARD

location_facility: Site 123: Northwell Health Neuroscience Institute

location_facility: Site 221: Neurology Center of New England

location_facility: Site 153: Toho University Ohashi Medical Center

location_facility: Site 192: Krakowski Szpital Specjalistyczny im. Jana Pawła II

location_facility: Site 134: Neurology and Sleep Disorders Clinic

location_facility: Site 156: Indiana University Health Neuroscience Center

location_facility: Site 160: Forbes Norris MDA/ALS Research and Treatment Center

location_facility: Site 140: Haukeland University Hospital / Health Bergen

location_facility: Site 205: Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

location_facility: Site 191: Centre Hosptitalier Universitaire d'Angers

location_facility: Site 201: Centrum Medyczne Pratia - Warszawa

location_facility: Site 33: Detroit medical Center - University Health Center

location_facility: Site 45: Center for Neurological Disorders

location_facility: Site 31: University of California Irvine

location_facility: Site 32: Kansas University Medical Center Research Institute

location_facility: Site 168: Hospital de la Santa Creu i Sant Pau

location_facility: Site 188: North Shore Medical Group - Glenview

location_facility: Site 135: Augusta University Medical Center

location_facility: Site 213: Niepubliczny Zakład Opieki Zdrowotnej NOVO-MED

location_facility: Site 119: Oxford University Hospitals NHS Foundation Trust

location_facility: Site 179: Kagawa University Hospital - Collagen disease/Rheumatic int

location_facility: Site 11: Montreal Neurological Institute and Hospital (McGill University)

location_facility: Site 126: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Site 211: Specjalistyczne Gabinety Sp. z o.o.

location_facility: Site 194: Twoja Przychodnia - Centrum Medyczne Nowa Sól

location_facility: Site 4: University of Southern California

location_facility: Site 40: Allegheny Neurological Associates

location_facility: Site 116: Neuromuscular Clinic and Research Center

location_facility: Site 132: Università Cattolica del Sacro Cuore - Campus di Milano

location_facility: Site 44: London Health Sciences Centre University Hospital

location_facility: Site 163: Tokyo Medical University Hospital

location_facility: Site 195: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Site 128: Medical University of South Carolina

location_facility: Site 133: Hospital Universitari Vall d'Hebrón

location_facility: Site 138: Hospital Universitario de Basurto

location_facility: Site 19: University of Texas Southwestern

location_facility: Site 169: International University of Health and Welfare Narita Hospital

location_facility: Site 164: University of Virginia Health System

location_facility: Site 105: Pitié-Salpêtrière University Hospital

location_facility: Site 193: Krakowska Akademia Neurologii - Centrum Neurologii Kliniczne


title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

acronym: REDIRECT

summary:
This is a phase II study to evaluate the antitumor activity and safety of AFM13 given as monotherapy in patients with CD30-positive T-cell lymphoma. The investigational medicinal product AFM13 is a tetravalent bispecific chimeric (anti-human CD30 x anti-human CD16A) recombinant antibody construct which is being developed to treat CD30-positive malignancies.

Patients who suffer from peripheral T-cell lymphoma or transformed mycosis fungoides, whose tumor expresses the surface marker CD30, and who have relapsed after an earlier treatment or have refractory disease will be enrolled into this study if all of the study entry criteria are fulfilled. Dependent on their disease type and the magnitude of CD30 expression, study participants will be assigned to one of 3 study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion).

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the potential formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

Approx. 1 month after the last dose of AFM13 there will be a final study visit to assess the patients' health status after therapy, followed by quarterly phone contacts to check on their overall health status and long-term survival.

design_allocation: Non-Randomized

lead_sponsor: Affimed GmbH

location_country:
Italy
United States
France
Poland
Australia
Russian Federation
Spain
Turkey
Germany
Korea, Republic of

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Ist.Ematologia E Oncologia Medica L.E A.Seragnoli

location_facility: University of Michigan Health | Rogel Cancer Center

location_facility: Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial Hematologii i Transplantologii Szpiku

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Ic Hastaliklari Anabilim Dali Hematoloji Bilim Dali Fatih

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

location_facility: First State Saint-Petersburg Pavlov Medical University

location_facility: Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

location_facility: University of California Los Angeles (UCLA) Health

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Ochsner Clinic Foundation/Precision Cancer Therapies Program

location_facility: Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırm Hastanesi

location_facility: Seoul National University Bundang Hospital

location_facility: Gazi University Faculty of Medicine, Department of Internal Diseases

location_facility: KaradenizTeknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Kocaeli University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim Arastirma Hastanesi Hematoloji Klinigi Ankara

location_facility: Tekirdag Namik Kemal Universitesi Saglik Uygulama ve Arastirma Hastanesi

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: GUZ Leningrad Regional Clinical Hospital

location_facility: Azienda Unita Sanitaria Locale di Ravenna - Ospedale S. Maria delle Croci di Ravenna

location_facility: Kliniken Essen Sued - Evangelisches Krankenhaus Essen-Werden gGmbH

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Ankara University Faculty of Medicine, Department of Internal Diseases, Hematology Division

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Egitim Merkezi

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Emory University Clinic/Winship Cancer Institute

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Duran I Reynals Hospital Catalan Institute Of Oncology


location_country:
Italy
Austria
Brazil
India
Mexico
France
Czechia
Japan
Israel
Poland
Argentina
Belgium
Russian Federation
Spain
Turkey
Denmark
United Kingdom

acronym: JUVE-BALM

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

title: Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis

summary: The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA).


title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

summary:
The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC).

The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United States
Korea, Republic of
France


ReferenceCitation: Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1). pii: e000564. doi: 10.1136/jitc-2020-000564.

family: Yoo

full_name: Changhoon Yoo

given: Changhoon

family: Oh

full_name: Do-Youn Oh

given: Do-Youn

family: Choi

full_name: Hye Jin Choi

given: Hye Jin

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Ueno

full_name: Makoto Ueno

given: Makoto

family: Kondo

full_name: Shunsuke Kondo

given: Shunsuke

family: Chen

full_name: Li-Tzong Chen

given: Li-Tzong

family: Osada

full_name: Motonobu Osada

given: Motonobu

family: Helwig

full_name: Christoph Helwig

given: Christoph

family: Dussault

full_name: Isabelle Dussault

given: Isabelle

family: Ikeda

full_name: Masafumi Ikeda

given: Masafumi

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Yonsei University Medical Library - YUHSpace

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

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

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Brazil
Chile
Spain
Germany
France
Japan
Poland
Argentina
Australia
China
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: 1L BTC Phase II/III Gemcitabine Plus Cisplatin With or Without M7824

location_facility: University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion

location_facility: Vivantes Klinikum Neukoelln - Haematologie und Onkologie

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Ironwood Cancer & Research Centers - Chandler II

location_facility: University of Massachusetts Memorial Medical Center - Pediatrics

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Instituto de Investigaciones Metabolicas (IDIM)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine

location_facility: Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

location_facility: Fudan University Shanghai Cancer Hospital

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: Hospital San Pedro de Alcantara - Servicio de Oncologia

location_facility: Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie

location_facility: IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi

location_facility: Centro de Investigación Clínica Bradford Hill

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Mayo Clinic in Florida - Department of Neurology

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: University College London Hospitals - NIHR/Wellcome Trust

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Centre Georges François Leclerc - Oncologie Médicale

location_facility: National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

location_facility: Northwestern Center for Clinical Research

location_facility: The First Affiliated Hospital, College of Medicine,Zhejiang University

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz

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

title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

summary: Study consists of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study will evaluate whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic BTC compared to placebo, gemcitabine and cisplatin.


ReferenceCitation: Goss CH, Jain R, Seibold W, Picard AC, Hsu MC, Gupta A, Fajac I. An innovative phase II trial to establish proof of efficacy and optimal dose of a new inhaled epithelial sodium channel inhibitor BI 1265162 in adults and adolescents with cystic fibrosis: BALANCE-CF(TM) 1. ERJ Open Res. 2020 Dec 7;6(4). pii: 00395-2020. doi: 10.1183/23120541.00395-2020. eCollection 2020 Oct.

apc_source: doaj

family: Goss

full_name: Christopher H. Goss

given: Christopher H.

family: Jain

full_name: Raksha Jain

given: Raksha

family: Seibold

full_name: Wolfgang Seibold

given: Wolfgang

family: Picard

full_name: Anne-Caroline Picard

given: Anne-Caroline

family: Hsu

full_name: Ming-Chi Hsu

given: Ming-Chi

family: Gupta

full_name: Abhya Gupta

given: Abhya

family: Fajac

full_name: Isabelle Fajac

currency_apc_doaj: EUR

journal_name: ERJ Open Research

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

title: An innovative phase II trial to establish proof of efficacy and optimal dose of a new inhaled epithelial sodium channel inhibitor BI 1265162 in adults and adolescents with cystic fibrosis: BALANCE-CFTM 1

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https:// trials.boehringer-ingelheim.com/trial_results/ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Sweden
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Virginia Commonwealth University Health Systems

location_facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Stockholm CF-Center , B59, Huddinge Universitetssjukhus

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: The University of North Carolina at Chapel Hill

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: University of Texas Southwestern Medical Center

title: A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1

summary: The primary objective of this trial is to assess the efficacy, safety and pharmacokinetics of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler versus placebo in adolescents and adult patients with cystic fibrosis.


title: A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)

acronym: NEUPART

summary: This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.

study_type: Observational

time_perspective: Prospective

lead_sponsor: UCB Biopharma S.P.R.L.

location_country:
Italy
France
Spain
Germany
United Kingdom


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

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Italy
Brazil
Sweden
Switzerland
Netherlands
Germany
France
Bulgaria
Japan
Israel
Malaysia
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: FREESIA

location_facility: Japanese Red Cross Society Nagano Hospital

location_facility: Henry Ford Hospital - Hematology/oncology

location_facility: Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: IBCC Instituto Brasileiro de Controle do Cancer

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes

location_facility: Hospital de Base de São José do Rio Preto

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: Specialized Hospital for Active Treatment of Haematologic Diseases

location_facility: Universitaets-Medizin der Johann-Gutenberg-Unversitaet - III. Medizinische Klinik und Poliklinik

location_facility: The Hospital of Hyogo College of Medicine

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: University Hospitals Cleveland Medical Center

location_facility: MD Anderson Cancer Center - University of Texas

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

summary: The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.


ipd_sharing_description:
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

lead_sponsor: CSL Behring

location_country:
Italy
Switzerland
Mexico
Germany
France
Japan
Poland
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom
Ukraine

acronym: RECLAIIM

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: St. Petersburg City Rheumatological Hospital 25

location_facility: Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2

location_facility: The Perron Institute for Neurological and Translational Science

location_facility: CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix

location_facility: Centro Integral en Reumatologia, SA de CV

location_facility: Sutter Pacific Medical Foundation FORBES Norris MDA ALS Research and Treatment Center

location_facility: Mechnikov Institute of Microbiology and Immunology of NAMS of Ukraine Kharkiv City Multispecialty Hospital

location_facility: State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital 3

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Tokyo Medical And Dental University Medical Hospital

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

location_facility: University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC)

location_facility: Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

location_facility: CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: The University of Texas Medical School at Houston

location_facility: Tokyo Women's Medical University Hospital

location_facility: University of Sacred Heart Policlinico A. Gemelli

title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study

summary: This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.


title: Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy. (PROTEUS)

acronym: PROTEUS

summary:
This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period.

One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy.

It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments.

Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.

location_country:
Italy
United Kingdom
France
Portugal

location_facility: Centre d'Investigation Clinique - Centre National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

location_facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

location_facility: Centre for Clinical Trials, Department of Ophthalmology, University of Padova

location_facility: Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael

location_facility: Serviço de Oftalmologia,Hospital de Vila Franca de Xira

location_facility: Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust

location_facility: Department of Ophthalmology, Lariboisière Hospital

location_facility: Laser and Retinal Research Unit, King's Health Partners

location_facility: Department of Ophthalmology, University Hospital, CHU Dijon

intervention_type: Procedure


title: Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

summary: Semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (NASH), as it may improve liver damage. Participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. The study will last for about 61 weeks in total. Participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. Some of the clinic visits may be spread over more days. Participants will need to inject themselves with medicine under the skin. Participants will have to do this once a week for 48 weeks. The study includes magnetic resonance imaging (MRI) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. For some tests participants may need to remove some items of clothing. Participants will stop in the study if the doctor thinks that there are any risks for their health. The information collected from participants during the study may help them and other patients with NASH in the future. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
United States
France
Spain
Germany
United Kingdom


title: Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants

summary: The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.

primary_purpose: Prevention

lead_sponsor: Nestlé

location_country: Germany France Netherlands

location_facility: Hôpital de la Croix Rousse, Service de réanimation néonatale

location_facility: Maternité régionale de Nancy, Service de Néonatologie

location_facility: Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde

location_facility: Hôpital Arnaud de Villeneuve, Service de pédiatrie 2

location_facility: Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin

location_facility: Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin


lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Germany
France
Belgium
Spain
Canada

location_facility: Northwestern University, Feinberg School of Medicine

title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

summary: The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).


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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Spain
United States
United Kingdom
Canada

location_facility: Children s National Hospital CQTI571A2306

location_facility: Cincinnati Children s Hospital Medical Center

title: An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

summary: A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.


ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Greece
Belgium
Australia
Russian Federation
Croatia
France
Slovakia
Kuwait
Argentina
Saudi Arabia
Bulgaria
Hungary
Portugal
Germany
United States
Italy
Serbia
Czechia
Tunisia
Israel
Spain
Turkey

title: An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

summary: This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)

acronym: M-STAR

summary: The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy

ReferenceCitation: Schmahmann JD, Pierce S, MacMore J, L'Italien GJ. Development and Validation of a Patient-Reported Outcome Measure of Ataxia. Mov Disord. 2021 Oct;36(10):2367-2377. doi: 10.1002/mds.28670. Epub 2021 Jun 11.

name: Ataxia Center, Cognitive Behavioral Neurology Unit, Laboratory for Neuroanatomy and Cerebellar Neurobiology Massachusetts General Hospital and Harvard Medical School  Boston Massachusetts USA

family: Schmahmann

full_name: Jeremy D. Schmahmann

given: Jeremy D.

family: Pierce

full_name: Samantha Pierce

given: Samantha

family: MacMore

full_name: Jason MacMore

given: Jason

name: Global Health Outcomes and Epidemiology Biohaven Pharmaceuticals  New Haven Connecticut USA

family: L'Italien

full_name: Gilbert J. L'Italien

given: Gilbert J.

journal_name: Movement Disorders

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Development and Validation of a Patient‐Reported Outcome Measure of Ataxia

lead_sponsor: Biohaven Pharmaceuticals, Inc.

location_country:
Italy
Austria
Germany
France
United States
United Kingdom

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Parkinson-Studienzentrum, Klinik für Neurologie

location_facility: Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

location_facility: Unité d'investigation clinique de Neurologie Rez-de-jardin, Bloc Hopital CHU Pontchaillou

location_facility: Confraternitaet Privatklinik Josefstadt in Wien

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona

location_facility: Pennsylvania State University Hershey Medical Center

location_facility: Parkinson's Disease and Movement Disorders Center at the University of Pennsylvania

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

location_facility: St. Josef - Hospital Bochum, Kardiologische Studienambulanz

location_facility: Columbia University Medical Center, Neurological Institute

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: UCLA Medical Center / Neurological Services

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Campus for Ageing and Vitality (NGH)

location_facility: UC San Diego Department of Neurosciences

location_facility: CRC Core Facility Medizinische Hochschule Hannover (MHH)

location_facility: Klinik für Neurologie - UKSH - Campus Kiel

location_facility: NYU School of Medicine, NYU Dysautonomia Center


lead_sponsor: Arena Pharmaceuticals

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Spain
Croatia
France
Lithuania
Poland
Slovakia
Thailand
Argentina
Moldova, Republic of
Canada
Korea, Republic of
Turkey
South Africa
Chile
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Lebanon
Mexico
Czechia
Israel
Georgia
Belarus
Estonia
Latvia

acronym: ELEVATE UC 52

location_facility: Klaipeda University Hospital, Department of Gastroenterology

location_facility: Karkonoskie Centrum Badan Klinicznych Lexmedica

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Centro Hospitalar e Universitário de Coimbra Serviço Gastrenterologia

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic LLC

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: LTD Israeli-Georgian Medical Research clinic Helsicore

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: LLC "Multidisciplinary Medical Clinic "Anthurium"

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD,Clinical Research Center

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia - Dzial Farmacji

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Kocaeli University Research and Training Hospital

location_facility: Austin Health Gastroenterology Department

location_facility: Health Care Institution "10th City Clinical Hospital"

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: Medical Center Nov Rehabilitatsionen Tsentar EOOD

location_facility: Bekes Megyei Kozpont Korhaz Dr Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Clinic for Internal Medicine I, University hospital Schleswig-Holstein, Campus Kiel

location_facility: Marshall University Department of Clinical Research

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SAIH "Kemerovo Regional Clinical Hospital

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Belfast Health and Social Care Trust Royal Victoria Hospital

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Fundación Respirar- Centro Médico Dra. De Salvo

location_facility: Private Educational Institution of Higher Education "Medical University REAVIZ"

location_facility: Digestive Health Specialists of the Southeast

location_facility: RTL SM SRL, Institutia Medico-Sanitara Publica Spitalul Clinic, Sectia Proctologie

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: SZTE AOK I.st dept. of Internal Medicine.

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: UMHATEM "N.I.Pirogov" EAD, Gastroenterology Department/Clinical Research center, next to the chimney

location_facility: West Hertfordshire Hospitals NHS Trust Hemel Hempstead General Hospital

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: 1th Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: National Military Medical Clinical Center Main Military Clinical Hospital

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: Saint George University Hospital Medical Center

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Spedali Civili di Brescia, U.O. Gastroenterologia

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

location_facility: P. Stradins Clinical University Hospital

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Clinical Hospital of the Ministry of Health, Labor and Social Protection

location_facility: Dr. Carol Davila Central University Emergency Military Hospital

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: Kyungpook National University Chilgok Hospital

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

location_facility: Communal Institution City Clinical Hospital #6, Department of Gastroenterology

location_facility: Duke University Medical Center GI Clinical Research Unit

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: San Diego Gastroenterology Medical Associates

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.


title: A Phase I, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed OR Refractory Non-Hodgkin Lymphomas (R/R NHL).

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
Austria
United States
France
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: LKH - Universitätsklinikum der PMU Salzburg

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

location_facility: Cross Cancer Institute University of Alberta

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"