Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

PHASE3TerminatedINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

December 18, 2017

Primary Completion Date

May 27, 2020

Study Completion Date

December 21, 2020

Conditions
Diffuse Cutaneous Systemic Sclerosis
Interventions
DRUG

Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily.

DRUG

Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily.

OTHER

Placebo oral capsule

Subjects will receive placebo twice daily.

Trial Locations (74)

3065

St Vincent's Hospital, Melbourne

5000

Royal Adelaide Hospital, Adelaide

10032

Columbia University Medical Center, New York

10065

Hospital for Special Surgery, New York

12203

The Steffens Scleroderma at The Center for Rheumatology, Albany

15261

UPMC Arthritis and Autoimmunity Center, Falk Clinic, Pittsburgh

19104

University of Pennsylvania Health System - PCAM, Dept. of Rheumatology, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

21224

John Hopkins University, Scleroderma Center, Baltimore

29425

Medical University of South Carolina, Charleston

43614

University of Toledo, Toledo

44195

Cleveland Clinic, Cleveland

48109

Michigan Medicine, Ann Arbor

53226

Medical College of Wisconsin/Froedtert Hospital, Milwaukee

55455

University of Minnesota Health Clinical Research Unit, Minneapolis

60611

Northwestern University, Chicago

69120

Universitätsklinikum Heidelberg, Heidelberg

70112

Tulane University Medical Center, New Orleans

75231

Metroplex Clinical Research Center, Dallas

77030

UTP Rheumatology Clinic, Houston

80045

University of Colorado Anschutz Medical Campus, Aurora

84132

University of Utah Hospitals and Clinics, Salt Lake City

90045

Pacific Arthritis Care Center, Los Angeles

90095

UCLA, Los Angeles

92037

University of California San Diego, La Jolla

94304

Stanford University, Palo Alto

3109601

Rambam Health Corporation, Haifa

02114

Massachusetts General Hospital, Division of Rheumatology, Boston

02118

Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU), Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

08901

Rutgers Clinical Research Center, Robert Wood Johnson Medical School, New Brunswick

Unknown

Liverpool Hospital, Liverpool

Royal Prince Alfred Hospital, Sydney

Sir Mortimer B. Davis Jewish General Hospital, Montreal

The Arthritis Centre, Winnipeg

Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-, Berlin

University Hospital Cologne, Department of Dermatology and Venereology, Cologne

Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie, Cologne

Department of Internal Medicine 3, University of Erlangen-Nuremberg, Erlangen

University Medical Center Freiburg, Freiburg im Breisgau

Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz, Nauheim

University Hospital Ulm, Ulm

Bnai Zion Medical Center, Haifa

Meir Medical Center - Internal Medicine E, Kfar Saba

Sheba Medical Center, Ramat Gan

Kyushu University Hospital, Fukuoka

Kanazawa University Hospital, Kanazawa

Gunma University Hospital, Maebashi

Hokkaido University Hospital, Sapporo

National University Corporation Tohoku University Tohoku University Hospital, Sendai

Osaka University Hospital, Suita

Nippon Medical School Hospital, Tokyo

Yokohama City University Hospital, Yokohama

Leiden University Medical Center, Leiden

Erasmus Medical Center, Rotterdam

Haga Hospital, The Hague

Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie, Lublin

Medyczne Centrum Hetmanska, Poznan

Reum-Medica S.C, Wroclaw

Hanyang University Medical Center, Seoul

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

Hospital Universitari de la Santa Creu i Sant Pau, Barcelona

Hospital Universitario Doctor Peset, Valencia

Cantonal Hospital St. Gallen, Sankt Gallen

University Hospital Zurich, Zurich

Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), Leeds

Guy's and St.Thomas' NHS Foundation Trust, London

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

DD1 9SY

Ninewells Hospital, Dundee

NE7 7DN

Freeman Hospital, Newcastle

DY1 2HQ

Russell's Hall Hospital, Dudley

NW3 2QG

Royal Free Hospital London NHS Foundation Trust, London

M6 8HD

Salford Royal NHS Foundation Trust, Salford

Sponsors
All Listed Sponsors
lead

Corbus Pharmaceuticals Inc.

INDUSTRY

NCT03398837 - Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis | Biotech Hunter | Biotech Hunter