Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

Completed · Phase 3 · Has a placebo group

Conditions studied: Dermatomyositis

In brief

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 be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Key facts

Study ID

NCT03813160

Run by

Corbus Pharmaceuticals Inc.

People needed

176

Starts

2018-12-17

Expected to finish

2021-10-05

Last updated by the study team

2022-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Attune Health Center — Beverly Hills, California, United States
• UCLA Division of Rheumatology — Los Angeles, California, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota, Division of Rheumatic and Autoimmune Diseases — Minneapolis, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh, Division of Rheumatology — Pittsburgh, Pennsylvania, United States
• MUSC: Department of Neurology — Charleston, South Carolina, United States
• Austin Neuromuscular Center — Austin, Texas, United States
• Rheumatic Disease Center — Glendale, Wisconsin, United States
• University Hospital "Kaspela" Rheumatology Clinic — Plovdiv, Bulgaria
• UMHAT "St. Ivan Rilski" — Sofia, Bulgaria
• HonorHealth Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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