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Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)

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ClinicalTrials.gov Identifier: NCT03398837
Recruitment Status : Active, not recruiting
First Posted : January 16, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diffuse Cutaneous Systemic Sclerosis Drug: Lenabasum 5 mg Drug: Lenabasum 20 mg Other: Placebo oral capsule Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Cohort 1
Lenabasum 5 mg BID
Drug: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.

Experimental: Cohort 2
Lenabasum 20 mg BID
Drug: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.

Placebo Comparator: Cohort 3
Placebo BID
Other: Placebo oral capsule
Subjects will receive placebo twice daily.




Primary Outcome Measures :
  1. Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index. [ Time Frame: 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.

  2. Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score. [ Time Frame: American College of Rheumatology Combined Response Index score through study completion, up to 1 year. ]
    The ARC 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.

  3. Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity. [ Time Frame: Change from baseline through study completion, up to 1 year. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. ≥ 18 years of age at the time Informed Consent is signed.
  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.

Key Exclusion Criteria:

  1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398837


  Hide Study Locations
Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92037
Pacific Arthritis Care Center
Los Angeles, California, United States, 90045
UCLA
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
John Hopkins University, Scleroderma Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital, Division of Rheumatology
Boston, Massachusetts, United States, 02114
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota Health Clinical Research Unit
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rutgers Clinical Research Center, Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
The Steffens Scleroderma at The Center for Rheumatology
Albany, New York, United States, 12203
Columbia University Medical Center
New York, New York, United States, 10032
Hospital for Special Surgery
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
University of Toledo
Toledo, Ohio, United States, 43614
United States, Pennsylvania
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
Philadelphia, Pennsylvania, United States, 19104
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
UTP Rheumatology Clinic
Houston, Texas, United States, 77030
United States, Utah
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Australia
Royal Adelaide Hospital
Adelaide, Australia, 5000
Liverpool Hospital
Liverpool, Australia
St Vincent's Hospital
Melbourne, Australia, 3065
Royal Prince Alfred Hospital
Sydney, Australia
Canada
Sir Mortimer B. Davis Jewish General Hospital
Montréal, Canada
The Arthritis Centre
Winnipeg, Canada
Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
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
Department of Internal Medicine 3, University of Erlangen-Nuremberg
Erlangen, Germany
University Medical Center Freiburg
Freiburg, Germany
Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
Köln, Germany
Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
Nauheim, Germany
University Hospital Ulm
Ulm, Germany
Israel
Rambam Health Corporation
Haifa, Israel, 3109601
Bnai Zion Medical Center
Haifa, Israel
Meir Medical Center - Internal Medicine E
Kefar Saba, Israel
Sheba Medical Center
Ramat Gan, Israel
Japan
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
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Hanyang University Medical Center
Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Haga Hospital
The Hague, Netherlands
Poland
Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
Lublin, Poland
Medyczne Centrum Hetmanska
Poznań, Poland
Reum-Medica S.C
Wrocław, Poland
Spain
Hospital Universitari de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Doctor Peset
Valencia, Spain
Switzerland
Cantonal Hospital St. Gallen
Saint Gallen, Switzerland
University Hospital Zurich
Zürich, Switzerland
United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Freeman Hospital
Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
Russell's Hall Hospital
Dudley, West Midlands, United Kingdom, DY1 2HQ
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
Leeds, United Kingdom
Royal Free Hospital London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Guy's and St.Thomas' NHS Foundation Trust
London, United Kingdom
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
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Principal Investigator: Robert Spiera, MD Professor of Clinical Medicine, Weill Cornell Medical College
Principal Investigator: Chris Denton, MD Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital

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Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03398837     History of Changes
Other Study ID Numbers: JBT101-SSc-002
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corbus Pharmaceuticals Inc.:
Scleroderma
cannabinoid receptor type 2 agonist
anabasum
JBT-101
lenabasum
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases