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 : Recruiting
First Posted : January 16, 2018
Last Update Posted : February 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Cutaneous Systemic Sclerosis||Drug: Lenabasum 5 mg Drug: Lenabasum 20 mg Other: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
Other: Placebo oral capsule
Subjects will receive placebo twice daily.
- 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.
- 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.
- 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.
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398837
|Contact: Lindsey Smith||1-617-963-0707||SScPatients@corbuspharma.com|
|Contact: Barbara White, MD||1-617-977-5077||SScPhysicians@corbuspharma.com|
Show 74 Study Locations
|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|