Status:
COMPLETED
Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis
Lead Sponsor:
Corbus Pharmaceuticals Inc.
Conditions:
Dermatomyositis
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 dermatomyositis. Approximately 150 subjects will b...
Detailed Description
Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lena...
Eligibility Criteria
Inclusion
- Fulfill at least one of the following criteria for dermatomyositis:
- Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b)
- ACR/EULAR criteria (Lundberg et al, 2017)
- Disease activity/severity fulfills at least one of the following three criteria:
- MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale \[VAS\]) and MMT-8 score ≤ 142 (out of 150 total possible)
- Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each)
- MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of \> 14
- Stable doses of immunosuppressive medications for DM as defined by:
- Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1
- Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening
Exclusion
- Unstable DM or DM with end-stage organ involvement at Screening or Visit 1
- Significant diseases or conditions other than DM that may influence response to the study drug or safety
- Any of the following values for laboratory tests at Screening:
- A positive pregnancy test (or at Visit 1)
- Hemoglobin \< 9 g/dL in males and \< 8 g/dL in females
- Neutrophils \< 1.0 × 10\^9/L
- Platelets \< 75 × 10\^9/L
- Creatinine clearance \< 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2021
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT03813160
Start Date
December 17 2018
End Date
October 5 2021
Last Update
August 16 2022
Active Locations (54)
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