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)
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
12actual
Sites
9
Countries
Brazil, Czechia, Mexico +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-04 | actual | When the study began enrolling |
| Primary completion | 2025-07-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-02 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Idiopathic Inflammatory Myositis
Interventions
- Drug: Daxdilimab — also filed as HZN-7734
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFEfficacy of daxdilimab compared to placebo as measured by Total Improvement Score (TIS)
measured At Week 24
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