Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

Inclusion Criteria

• •Fulfill at least 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 at least 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