Status:
TERMINATED
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Lead Sponsor:
Corbus Pharmaceuticals Inc.
Conditions:
Diffuse Cutaneous Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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). Approx...
Eligibility Criteria
Inclusion
- Key
- ≥ 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
- 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.
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT03398837
Start Date
December 18 2017
End Date
December 21 2020
Last Update
March 29 2021
Active Locations (74)
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1
University of California San Diego
La Jolla, California, United States, 92037
2
Pacific Arthritis Care Center
Los Angeles, California, United States, 90045
3
UCLA
Los Angeles, California, United States, 90095
4
Stanford University
Palo Alto, California, United States, 94304