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

Phase 3

Terminated

• Conditions: Diffuse Cutaneous Systemic Sclerosis
• Interventions: Other: Placebo oral capsule; Drug: Lenabasum 5 mg; Drug: Lenabasum 20 mg

• 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

Study Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Primary Completion: 2020-05-27
• Study Completion: 2020-12-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 365

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.

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)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Pacific Arthritis Care Center; 🇺🇸 Los Angeles, California, United States

UCLA; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States

John Hopkins University, Scleroderma Center; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital, Division of Rheumatology; 🇺🇸 Boston, Massachusetts, United States

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