Study identifier:D3463C00003
ClinicalTrials.gov identifier:NCT06455449
EudraCT identifier:N/A
CTIS identifier:2023-504022-19-01
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
-
All
240
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment.
Location
Status
Location
Taipei, Taiwan, Province of China, 112
Status
Recruiting
Location
Praha 2, Czech Republic, 12850
Status
Recruiting
Location
Boca Raton, FL, United States, 33486
Status
Recruiting
Location
Irvine, CA, United States, 92617
Status
Recruiting
Location
Fairway, KS, United States, 66205
Status
Recruiting
Location
Milwaukee, WI, United States, 53226
Status
Not yet recruiting
Location
Taichung, Taiwan, Province of China, 40447
Status
Recruiting
Location
Kaohsiung, Taiwan, Province of China, 833
Status
Recruiting
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) |
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