Dermatomyositis

Ongoing Phase 2 Dermatomyositis Trial

Corbus is actively recruiting patients to participate in its ongoing study of JBT-101 (also known as Anabasum) for the treatment of dermatomyositis. The study is a Phase 2, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and efficacy of JBT-101 (Anabasum) in patients with dermatomyositis.

Study participants will be screened for up to 28 days to ensure they meet study entry criteria. Following the initial screening, participants will be provided with either a dose of JBT-101 (Anabasum) or placebo for once a day dosing for 28 days. On the 29th day, participants will transition to twice a day dosing for 56 days. The total treatment period is 84 days. After the treatment period, participants will be followed for an additional 28 days.

  • Primary Endpoints: Change in CDASI Score, safety and tolerability
  • Secondary Endpoints: Quality of life, biomarkers of inflammation and disease activity in blood and skin, metabolipidomic profile and pharmacokinetics
  • Eligibility:
    • Ages Eligible for study: 18 years to 70 years
    • Genders eligible for study: both
  • Inclusion Criteria:
    • CDASI activity score ≥ 14
    • No difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase
    • Failed at least 3 months treatment with hydroxychloroquine
    • Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1)

Study participants who completed the first portion of the study have the option of enrolling into an open-label extension to receive Anabasum twice a day.

Site Contact Principal Investigator

University of Pennsylvania Perlman School of Medicine

3400 Civic Center Blvd
Philadelphia, PA 19104
United States

Victoria Werth, MD

215-898-0168
werth@mail.med.upenn.edu

Victoria Werth, MD