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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Terminated
Sponsor
Corbus Pharmaceuticals Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.