Trial Profile

A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 16 Oct 2025

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At a glance

Drugs Dazukibart (Primary) ; Dazukibart (Primary) ; Azathioprine; Betamethasone; Betamethasone; Budesonide; Deflazacort; Dexamethasone; Hydrocortisone; Hydroxychloroquine; Leflunomide; Methotrexate; Methotrexate; Methylprednisolone; Methylprednisolone; Mycophenolate mofetil; Prednisone; Proguanil; Triamcinolone
Indications Dermatomyositis; Myositis; Polymyositis
Focus Registrational; Therapeutic Use
Sponsors Pfizer

14 Oct 2025 Planned End Date changed from 28 Jul 2026 to 28 Jul 2027.
14 Oct 2025 Planned primary completion date changed from 28 Jul 2026 to 28 Jul 2027.
29 Jun 2025 Planned number of patients changed from 270 to 318.

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