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

Diffuse Cutaneous Systemic Sclerosis Clinical Trial

— RESOLVE-1  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03398837
• Other study ID #: JBT101-SSc-002
• Status: Terminated
• Phase: Phase 3
• Start date: December 18, 2017
• Est. completion date: December 21, 2020

Study information

• Verified date: March 2021
• Source: Corbus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 365
• Est. completion date: December 21, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Cutaneous Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
• Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.

Other:
• Placebo oral capsule
Subjects will receive placebo twice daily.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Liverpool Hospital	Liverpool
Australia	St Vincent's Hospital	Melbourne
Australia	Royal Prince Alfred Hospital	Sydney
Canada	Sir Mortimer B. Davis Jewish General Hospital	Montréal
Canada	The Arthritis Centre	Winnipeg
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	Department of Internal Medicine 3, University of Erlangen-Nuremberg	Erlangen
Germany	University Medical Center Freiburg	Freiburg
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
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
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Corporation	Haifa
Israel	Meir Medical Center - Internal Medicine E	Kefar Saba
Israel	Sheba Medical Center	Ramat Gan
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
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Netherlands	Leiden University Medical Center	Leiden	South Holland
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Haga Hospital	The Hague
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dzieciecej Uniwersytetu Medycznego w Lublinie	Lublin
Poland	Medyczne Centrum Hetmanska	Poznan
Poland	Reum-Medica S.C	Wroclaw
Spain	Hospital Universitari de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Doctor Peset	Valencia
Switzerland	Cantonal Hospital St. Gallen	Saint Gallen
Switzerland	University Hospital Zurich	Zürich
United Kingdom	Russell's Hall Hospital	Dudley	West Midlands
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)	Leeds
United Kingdom	Guy's and St.Thomas' NHS Foundation Trust	London
United Kingdom	Royal Free Hospital London NHS Foundation Trust	London
United Kingdom	Freeman Hospital	Newcastle	Tyne And Wear
United Kingdom	Salford Royal NHS Foundation Trust	Salford
United States	The Steffens Scleroderma at The Center for Rheumatology	Albany	New York
United States	Michigan Medicine	Ann Arbor	Michigan
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	John Hopkins University, Scleroderma Center	Baltimore	Maryland
United States	Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)	Boston	Massachusetts
United States	Massachusetts General Hospital, Division of Rheumatology	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	UTP Rheumatology Clinic	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Pacific Arthritis Care Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin
United States	University of Minnesota Health Clinical Research Unit	Minneapolis	Minnesota
United States	Rutgers Clinical Research Center, Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Tulane University Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery	New York	New York
United States	Stanford University	Palo Alto	California
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	University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	University of Toledo	Toledo	Ohio
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Corbus Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Israel,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.	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.	Change from baseline through study completion, up to 1 year.
Secondary	Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.	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.	Change from baseline through study completion, up to 1 year.
Secondary	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.