Universitätsklinikum Freiburg | Klinik fur Dermatologie und Venerologie
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The primary efficacy objective:
To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.
The secondary efficacy objectives include:
Other secondary objectives include:
Full description
The study will enroll 96 participants with 2 idiopathic inflammatory myositis populations:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Adult men or women 18 and ≤ 75 years of age at the time of signing the informed consent (ICF).
A diagnosis of definite or probable myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria:
Population 1: DM
Population 2: ASIM
Currently active myositis with all the following (a, b, and c) during screening:
Manual Muscle Testing (MMT 8) score < 142
At least 2 other abnormal core set measures (CSM) from the following list:
Global muscle damage score ≤ 5 on a 10 cm VAS on the myositis damage index (MDI).
Participants should be on stable standard of care therapy if tolerated; if they are not able to tolerate it or have failed standard of care, medications should have a washed out period.
Participants should be willing to taper corticosteroid dose per protocol when stable or improving.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
96 participants in 2 patient groups, including a placebo group
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Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
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