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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 April 2021
• Main ID: NCT03398837
• Date of registration: 05/01/2018
• Prospective Registration: No
• Primary sponsor: Corbus Pharmaceuticals Inc.
• Public title: Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis RESOLVE-1
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
• Date of first enrolment: December 18, 2017
• Target sample size: 365
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03398837
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Chris Denton, MD
• Affiliation: Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital

• Name: Robert Spiera, MD
• Affiliation: Professor of Clinical Medicine, Weill Cornell Medical College

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diffuse Cutaneous Systemic Sclerosis

Intervention(s)

Drug: Lenabasum 5 mg

Drug: Lenabasum 20 mg

Other: Placebo oral capsule

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

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.]

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.]

Secondary ID(s)

JBT101-SSc-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors