Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Interventions
- Registration Number
- NCT03398837
- Lead Sponsor
- Corbus Pharmaceuticals Inc.
- Brief Summary
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 365
- ≥ 18 years of age at the time Informed Consent is signed.
- Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
- Disease duration ≤ 6 years from the first non-Raynaud's symptom.
- No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.
Key
-
Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
-
Any of the following values for laboratory tests at Screening:
- A positive pregnancy test in women of childbearing potential;
- Hemoglobin < 9 g/dL for males and < 8 g/dL for females;
- Neutrophils < 1.0 ×10^9/L;
- Platelets < 75 ×10^9/L;
- Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
- Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Placebo oral capsule Placebo BID Cohort 1 Lenabasum 5 mg Lenabasum 5 mg BID Cohort 2 Lenabasum 20 mg Lenabasum 20 mg BID
- Primary Outcome Measures
Name Time Method Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score. American College of Rheumatology Combined Response Index score through study completion, up to 1 year. The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.
- Secondary Outcome Measures
Name Time Method Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score. Change from baseline through study completion, up to 1 year. mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.
Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index. Change from baseline through study completion, up to 1 year. It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.
Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity. Change from baseline through study completion, up to 1 year.
Trial Locations
- Locations (74)
John Hopkins University, Scleroderma Center
🇺🇸Baltimore, Maryland, United States
The Steffens Scleroderma at The Center for Rheumatology
🇺🇸Albany, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Rutgers Clinical Research Center, Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
🇺🇸Philadelphia, Pennsylvania, United States
Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Salford Royal NHS Foundation Trust
🇬🇧Salford, United Kingdom
Hospital Universitari de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Royal Free Hospital London NHS Foundation Trust
🇬🇧London, United Kingdom
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Freeman Hospital
🇬🇧Newcastle, Tyne And Wear, United Kingdom
Haga Hospital
🇳🇱The Hague, Netherlands
Medyczne Centrum Hetmanska
🇵🇱Poznań, Poland
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
🇬🇧Leeds, United Kingdom
Russell's Hall Hospital
🇬🇧Dudley, West Midlands, United Kingdom
Cantonal Hospital St. Gallen
🇨🇭Saint Gallen, Switzerland
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Guy's and St.Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
🇵🇱Lublin, Poland
Reum-Medica S.C
🇵🇱Wrocław, Poland
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
University Hospital Zurich
🇨🇭Zürich, Switzerland
Massachusetts General Hospital, Division of Rheumatology
🇺🇸Boston, Massachusetts, United States
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
🇺🇸Boston, Massachusetts, United States
University of Minnesota Health Clinical Research Unit
🇺🇸Minneapolis, Minnesota, United States
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
UTP Rheumatology Clinic
🇺🇸Houston, Texas, United States
Pacific Arthritis Care Center
🇺🇸Los Angeles, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
UCLA
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical College of Wisconsin/Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
St Vincent's Hospital
🇦🇺Melbourne, Australia
Liverpool Hospital
🇦🇺Liverpool, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, Australia
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
The Arthritis Centre
🇨🇦Winnipeg, Canada
Sir Mortimer B. Davis Jewish General Hospital
🇨🇦Montréal, Canada
University Medical Center Freiburg
🇩🇪Freiburg, Germany
University Hospital Cologne, Department of Dermatology and Venereology
🇩🇪Cologne, Germany
Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
🇩🇪Berlin, Germany
Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
🇩🇪Nauheim, Germany
Department of Internal Medicine 3, University of Erlangen-Nuremberg
🇩🇪Erlangen, Germany
University Hospital Ulm
🇩🇪Ulm, Germany
Meir Medical Center - Internal Medicine E
🇮🇱Kefar Saba, Israel
Rambam Health Corporation
🇮🇱Haifa, Israel
Kanazawa University Hospital
🇯🇵Kanazawa, Japan
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Gunma University Hospital
🇯🇵Maebashi, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Osaka University Hospital
🇯🇵Suita, Japan
National University Corporation Tohoku University Tohoku University Hospital
🇯🇵Sendai, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Leiden University Medical Center
🇳🇱Leiden, South Holland, Netherlands
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
🇩🇪Köln, Germany
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Bnai Zion Medical Center
🇮🇱Haifa, Israel