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 : Terminated (Sponsor terminated open-label extension)
First Posted : January 16, 2018
Last Update Posted : March 29, 2021
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|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)|
|Actual Enrollment :||365 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|
|Actual Primary Completion Date :||May 27, 2020|
|Actual Study Completion Date :||December 21, 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 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 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.
- 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 change from baseline in forced vital capacity. [ Time Frame: Change from baseline through study completion, up to 1 year. ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- ≥ 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.
Key Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398837
|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|
|Responsible Party:||Corbus Pharmaceuticals Inc.|
|Other Study ID Numbers:||
|First Posted:||January 16, 2018 Key Record Dates|
|Last Update Posted:||March 29, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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