Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2017-08
- Completion
- 2021-01-29
Outcome
Met primary endpoint
Stopped: “Sponsor terminated open-label extension.”
paper The adjusted least-squares mean for Cutaneous Dermatomyositis Disease Area and Severity Index activity decreased more for lenabasum, and the difference was significant PMID 35490744 ↗
release “study evaluating lenabasum for the treatment of skin-predominant dermatomyositis, demonstrating medically and statistically significant improvement in the Cutaneous Dermatomyositis Disease Area and Severity Index” corbuspharma.com ↗
Publications
- Stone CJ, Ahuja G, Lopes Almeida Gomes L, Poroye J, Faden DF, Xie L, Feng R, White B, Werth VP. Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study. JID Innov. 2024 Sep 5;5(1):100311. doi: 10.1016/j.xjidi.2024.100311. eCollection 2025 Jan.
- Werth VP, Hejazi E, Pena SM, Haber J, Zeidi M, Reddy N, Okawa J, Feng R, Bashir MM, Gebre K, Jadoo AS, Concha JSS, Dgetluck N, Constantine S, White B. Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: A Randomized Clinical Trial. J Invest Dermatol. 2022 Oct;142(10):2651-2659.e1. doi: 10.1016/j.jid.2022.03.029. Epub 2022 Apr 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenabasum | Small molecule | 20 mg | — |