Dermatomyositis

Phase 2 Dermatomyositis Trial (Ongoing)

Corbus has completed enrollment in the double-blind phase of its study of anabasum for the treatment of dermatomyositis. The study was a Phase 2, double-blind, randomized, placebo-controlled study investigating the safety, tolerability and efficacy of anabasum in patients with dermatomyositis.

Study participants were screened for up to 28 days to ensure they met study entry criteria. Following the initial screening, participants were provided with either a dose of anabasum or placebo for once a day dosing for 28 days. On the 29th day, participants were transitioned to twice a day dosing for 56 days. The total treatment period was 84 days. After the treatment period, participants were followed for an additional 28 days.

Study participants who complete the first portion of the study have the option of enrolling in a 12-month, open-label extension to receive anabasum twice a day.

  • 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)

For more information, contact:

DM patients contact: DMpatients@corbuspharma.com
Physicians contact: DMphysicians@corbuspharma.com
Other inquiries: info@corbuspharma.com

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