Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398837
Recruitment Status : Active, not recruiting
First Posted : January 16, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE January 16, 2018
Last Update Posted Date July 3, 2019
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03398837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • 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 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Cutaneous Systemic Sclerosis
Intervention  ICMJE
  • Drug: Lenabasum 5 mg
    Subjects will receive lenabasum 5 mg twice daily.
  • Drug: Lenabasum 20 mg
    Subjects will receive lenabasum 20 mg twice daily.
  • Other: Placebo oral capsule
    Subjects will receive placebo twice daily.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Lenabasum 5 mg BID
    Intervention: Drug: Lenabasum 5 mg
  • Experimental: Cohort 2
    Lenabasum 20 mg BID
    Intervention: Drug: Lenabasum 20 mg
  • Placebo Comparator: Cohort 3
    Placebo BID
    Intervention: Other: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 1, 2019)
365
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
354
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03398837
Other Study ID Numbers  ICMJE JBT101-SSc-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Corbus Pharmaceuticals Inc.
Study Sponsor  ICMJE Corbus Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Corbus Pharmaceuticals Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP