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First received: December 20, 2022

Clinical Trial: 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)

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Idiopathic Inflammatory Myositis

Study Type: INTERVENTIONAL


Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Daxdilimab Subcutaneous Injection in Adult Participants With Inadequately Controlled Dermatomyositis or Anti-synth

Brief Summary: 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:To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24.To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24.To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24.Other secondary objectives include:To characterize the pharmacokinetics…

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