Conditions: Dermatomyositis
Keywords: JBT-101, lenabasum, dermatomyositis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3 months treatment with hydroxychloroquine.

Detailed description:
Part A: An interventional, double-blind, randomized, placebo-control design will be used to test JBT-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis.

Part B: A one-year open-label design to test JBT-101 in subjects who completed Part A without permanent discontinuation of study product because of safety or tolerability reasons.

Arms:
arm 1: Part A: JBT-101 20 mg capsule once a day on Days 1-28, then 20 mg capsule twice a day on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. arm 2: Part A: Placebo capsule once a day on Days 1-28, then placebo capsule twice a day on Days 29-84.

Part B: Placebo twice daily on Days 1 - 365 of the OLE.

Interventions: intervention 1: JBT-101 intervention 2: Placebo
Intervention descriptions: intervention 1: Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.

Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE. intervention 2: Part A: Once daily on Days 1-28, then twice daily on Days 29-84.

Part B: Placebo twice daily on Days 1 - 365 of the OLE.

Protocol document:
Prot_000.pdf: 





















































































































































































































SAP_001.pdf: