A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)
96 patients around the world
Available in Spain, Mexico, United States
The study will enroll 96 participants with 2 idiopathic inflammatory myositis
populations:
- Population 1 or dermatomyositis (DM): participants with DM with definite or probable
myositis according to the American College of Rheumatology/European League Against
Rheumatism 2017 (ACR/EULAR 2017) criteria and a DM rash.
- Population 2 or anti-synthetase inflammatory myositis (ASIM): participants with ASIM
with definite or probable myositis according to ACR/EULAR 2017 criteria and a
positive ASIM associated antibody.
Participants will be randomized by population in a 1:1 ratio and receive investigational
product (IP) daxdilimab or placebo by subcutaneous injection.
The estimated total study duration will be up to 60 weeks.
Acquired from Horizon in 2024.
Horizon Therapeutics Ireland DAC
2Research sites
96Patients around the world
This study is for people with
Inflammatory Myopathies
Dermatomyositis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
Sites
Hospital Universitario Dr. José Eleuterio González
Recruiting
Av. Dr. José Eleuterio González, Mitras Centro, 64460 Monterrey, N.L., Mexico
Accelerium Clinical Research
Recruiting
Modesto Arreola 917 Oriente, Col Centro Monterrey, Nuevo Leon, 64000