Study identifier:D3463C00003
ClinicalTrials.gov identifier:NCT06455449
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Polymyositis, Dermatomyositis
Phase 3
No
Anifrolumab (blinded), Anifrolumab (unblinded, open label)
All
240
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab (subcutaneous weekly injection) Anifrolumab subcutaneous injection once weekly | Combination Product: Anifrolumab (blinded) Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks Other Name: Treatment arm (blinded) Combination Product: Anifrolumab (unblinded, open label) At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks Other Name: treatment arm (unblinded) |
Placebo Comparator: Placebo (subcutaneous weekly injection) Matched placebo control subcutaneous injection once weekly | Other: Placebo Matched placebo delivered subcutaneously, once weekly for 52 weeks Other Name: Placebo arm (blinded) |