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

NCT03398837 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: JBT101-SSc-002
• Study Type: interventional
• Target: 365
• Locations: 12 countries
• Sites: 74

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.

Conditions

Diffuse Cutaneous Systemic Sclerosis

Keywords

Scleroderma; cannabinoid receptor type 2 agonist; anabasum; JBT-101; lenabasum

Outcome Measures

Primary Outcomes (1)

• Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.

  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.

  American College of Rheumatology Combined Response Index score through study completion, up to 1 year.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (3)

Cohort 1

EXPERIMENTAL

Lenabasum 5 mg BID

Drug: Lenabasum 5 mg

Cohort 2

EXPERIMENTAL

Lenabasum 20 mg BID

Drug: Lenabasum 20 mg

Cohort 3

PLACEBO COMPARATOR

Placebo BID

Other: Placebo oral capsule

Interventions

Lenabasum 5 mg DRUG

Subjects will receive lenabasum 5 mg twice daily.

Cohort 1

Lenabasum 20 mg DRUG

Subjects will receive lenabasum 20 mg twice daily.

Cohort 2

Placebo oral capsule OTHER

Subjects will receive placebo twice daily.

Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: lead

Study Sites (74)

University of California San Diego

La Jolla, California, 92037, United States

Location

Pacific Arthritis Care Center

Los Angeles, California, 90045, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

John Hopkins University, Scleroderma Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital, Division of Rheumatology

Boston, Massachusetts, 02114, United States

Location

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

Boston, Massachusetts, 02118, United States

Location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota Health Clinical Research Unit

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Rutgers Clinical Research Center, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

The Steffens Scleroderma at The Center for Rheumatology

Albany, New York, 12203, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Hospital for Special Surgery

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Arthritis and Autoimmunity Center, Falk Clinic

Pittsburgh, Pennsylvania, 15261, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

UTP Rheumatology Clinic

Houston, Texas, 77030, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Liverpool Hospital

Liverpool, Australia

Location

St Vincent's Hospital

Melbourne, 3065, Australia

Location

Royal Prince Alfred Hospital

Sydney, Australia

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada

Location

The Arthritis Centre

Winnipeg, Canada

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

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

Berlin, Germany

Location

University Hospital Cologne, Department of Dermatology and Venereology

Cologne, Germany

Location

Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie

Cologne, Germany

Location

Department of Internal Medicine 3, University of Erlangen-Nuremberg

Erlangen, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, Germany

Location

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

Nauheim, Germany

Location

University Hospital Ulm

Ulm, Germany

Location

Rambam Health Corporation

Haifa, 3109601, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Meir Medical Center - Internal Medicine E

Kfar Saba, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Kanazawa University Hospital

Kanazawa, Japan

Location

Gunma University Hospital

Maebashi, Japan

Location

Hokkaido University Hospital

Sapporo, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Sendai, Japan

Location

Osaka University Hospital

Suita, Japan

Location

Nippon Medical School Hospital

Tokyo, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

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

Lublin, Poland

Location

Medyczne Centrum Hetmanska

Poznan, Poland

Location

Reum-Medica S.C

Wroclaw, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Hospital Universitari de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Spain

Location

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Freeman Hospital

Newcastle, Tyne and Wear, NE7 7DN, United Kingdom

Location

Russell's Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)

Leeds, United Kingdom

Location

Royal Free Hospital London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Guy's and St.Thomas' NHS Foundation Trust

London, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

lenabasum

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 16, 2018
• Study Start: December 18, 2017
• Primary Completion: May 27, 2020
• Study Completion: December 21, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

KR (4); AU (4); NL (3); IL (4); US (27); DE (8); CA (2); JP (8); ES (2); CH (2); GB (7); PL (3)