Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Arthur Kavanaugh

Description

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.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Keywords

Diffuse Cutaneous Systemic Sclerosis Scleroderma cannabinoid receptor type 2 agonist anabasum JBT-101 lenabasum Sclerosis Scleroderma, Systemic Scleroderma, Diffuse Lenabasum 5 mg Lenabasum 20 mg

Eligibility

For people ages 18 years and up

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:
  3. A positive pregnancy test in women of childbearing potential;
  4. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;
  5. Neutrophils < 1.0 ×109/L;

  6. Platelets < 75 ×109/L;

  7. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
  8. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
  9. 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.

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Pacific Arthritis Care Center accepting new patients
    Los Angeles California 90045 United States

Lead Scientist

  • Arthur Kavanaugh
    Research Interests Innovative strategies for the treatment of patients with rheumatoid arthritis and other rheumatic diseases. Prognostic and predictive factors for outcomes in rheumatic diseases. Research program on innovative approaches to various immunologic diseases, particularly novel biologic therapies.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Corbus Pharmaceuticals Inc.
ID
NCT03398837
Phase
Phase 3
Study Type
Interventional
Last Updated