Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
NCT ID: NCT03398837
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
365 participants
INTERVENTIONAL
2017-12-18
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
Lenabasum 5 mg BID
Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
Cohort 2
Lenabasum 20 mg BID
Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.
Cohort 3
Placebo BID
Placebo oral capsule
Subjects will receive placebo twice daily.
Interventions
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Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.
Placebo oral capsule
Subjects will receive placebo twice daily.
Eligibility Criteria
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Inclusion Criteria
2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3. Disease duration ≤ 6 years from the first non-Raynaud's symptom.
4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.
Exclusion Criteria
2. Any of the following values for laboratory tests at Screening:
1. A positive pregnancy test in women of childbearing potential;
2. Hemoglobin \< 9 g/dL for males and \< 8 g/dL for females;
3. Neutrophils \< 1.0 ×10\^9/L;
4. Platelets \< 75 ×10\^9/L;
5. Creatinine clearance \< 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
6. Aspartate aminotransferase or alanine aminotransferase \> 2.0 × upper limit of normal.
3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
18 Years
ALL
No
Sponsors
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Corbus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Spiera, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Clinical Medicine, Weill Cornell Medical College
Chris Denton, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
Locations
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University of California San Diego
La Jolla, California, United States
Pacific Arthritis Care Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
John Hopkins University, Scleroderma Center
Baltimore, Maryland, United States
Massachusetts General Hospital, Division of Rheumatology
Boston, Massachusetts, United States
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
Boston, Massachusetts, United States
Michigan Medicine
Ann Arbor, Michigan, United States
University of Minnesota Health Clinical Research Unit
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgers Clinical Research Center, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
The Steffens Scleroderma at The Center for Rheumatology
Albany, New York, United States
Columbia University Medical Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Toledo
Toledo, Ohio, United States
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
Philadelphia, Pennsylvania, United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
UTP Rheumatology Clinic
Houston, Texas, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, , Australia
Liverpool Hospital
Liverpool, , Australia
St Vincent's Hospital
Melbourne, , Australia
Royal Prince Alfred Hospital
Sydney, , Australia
Sir Mortimer B. Davis Jewish General Hospital
Montreal, , Canada
The Arthritis Centre
Winnipeg, , Canada
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
Berlin, , Germany
University Hospital Cologne, Department of Dermatology and Venereology
Cologne, , Germany
Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
Cologne, , Germany
Department of Internal Medicine 3, University of Erlangen-Nuremberg
Erlangen, , Germany
University Medical Center Freiburg
Freiburg im Breisgau, , Germany
Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
Nauheim, , Germany
University Hospital Ulm
Ulm, , Germany
Rambam Health Corporation
Haifa, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Meir Medical Center - Internal Medicine E
Kfar Saba, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kyushu University Hospital
Fukuoka, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Gunma University Hospital
Maebashi, , Japan
Hokkaido University Hospital
Sapporo, , Japan
National University Corporation Tohoku University Tohoku University Hospital
Sendai, , Japan
Osaka University Hospital
Suita, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haga Hospital
The Hague, , Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
Lublin, , Poland
Medyczne Centrum Hetmanska
Poznan, , Poland
Reum-Medica S.C
Wroclaw, , Poland
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitari de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Ninewells Hospital
Dundee, Scotland, United Kingdom
Freeman Hospital
Newcastle, Tyne and Wear, United Kingdom
Russell's Hall Hospital
Dudley, West Midlands, United Kingdom
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
Leeds, , United Kingdom
Royal Free Hospital London NHS Foundation Trust
London, , United Kingdom
Guy's and St.Thomas' NHS Foundation Trust
London, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Countries
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Other Identifiers
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JBT101-SSc-002
Identifier Type: -
Identifier Source: org_study_id
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