Trial To Evaluate Efficacy And Safety Of Lenabasum In Dermatomyositis

Overview

About this study

what is the efficacy of lenabasum compared to placebo in subjects with dermatomyositis (DM) as measured by TotalImprovement Score (TIS)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: - Fulfill one of the following criteria for dermatomyositis: 1. Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b) 2. ACR/EULAR criteria (Lundberg et al, 2017) - Disease activity/severity fulfills one of the following three criteria: 1. MDGA ≥ 3 cm (0 - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of 150 total possible) 2. Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each) 3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14 - Stable doses of immunosuppressive medications for DM as defined by: 1. Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1 2. Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening Exclusion Criteria: - 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: 1. A positive pregnancy test (or at Visit 1) 2. Hemoglobin < 9 g/dL in males and < 8 g/dL in females 3. Neutrophils < 1.0 × 10^9/L 4. Platelets < 75 × 10^9/L 5. 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Closed for enrollment

Contact information:

Aaron Mangold

mangold.aaron@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Jaimin Shah, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available