A phase 2, randomized, double-blind, placebo-controlled, efficacy and safety study of daxdilimab subcutaneous injection in adult participants with adequately controlled dermatomyositis or anti-synthetase inflammatory myositis
Primary Objective
To study the safety and efficacy of daxdilimab subcutaneous injection in adult participants with inadequately controlled dermatomyositis or anti-synthetase inflammatory
Description
This study is a phase 2, randomized controlled proof of concept study to assess the efficacy and safety of daxdilimab in participants 18 to 75 years old with DM or ASIM. The estimated total study duration is 60 weeks with visits to clinic every 4 weeks. Participants will be randomized in a 1:1 ratio.
Details
Age
Adult
Eligibility
Participants should have a definite or probable myositis according to ACR/EULAR 2017 criteria.
Participants should be on stable standard of care therapy if tolerated, if not tolerated they should be washed out.
If female and of child bearing age, they should not be breastfeeding, pregnant and on a protocol approved form of contraception.
Participants should weigh less than 352 pounds at screening visit.
Participants with diagnosis of immune-mediated necrotizing myopathy (IMNM), includion body myositis, or drug induced myositis are excluded.
Participants with current inflammatory skin diseases other than DM or ASIM that could interfere with study assessment will be excluded.
Additional inclusion and exclusions apply.
Locations
Barbara Davis Center
University of Colorado Hospital
Principal Investigator
Elena Weinstein
Study ID
Protocol Number: 23-0062
Is this Study for You?
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers