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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 : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Placebo BID
Other: Placebo oral capsule
Subjects will receive placebo twice daily.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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
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.

Information from the National Library of Medicine

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


Contacts
Contact: Lindsey Smith 1-617-963-0707 SScPatients@corbuspharma.com
Contact: Barbara White, MD 1-617-977-5077 SScPhysicians@corbuspharma.com

  Show 62 Study Locations
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
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.
ClinicalTrials.gov Identifier: NCT03398837     History of Changes
Other Study ID Numbers: JBT101-SSc-002
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
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

Keywords provided by Corbus Pharmaceuticals Inc.:
Scleroderma
cannabinoid receptor type 2 agonist
anabasum
JBT-101
lenabasum

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases