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Dazukibart in Dermatomyositis and Polymyositis
NCT05895786Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2023
- Primary completion
- Jul 2030
- Countries
- 20
- Sponsor
- Pfizer
- Modality
- Monoclonal Antibodies
- Drugs
- dazukibart
- Conditions
- dermatomyositis (DM)polymyositis (PM)
01
Overview
Phase 3, randomised, double-blind trial in dermatomyositis (DM) and polymyositis (PM) comparing Placebo with PF-06823859 (2 arms). Primary endpoint: Total Improvement Score at 52 weeks. Started May 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo IV every 4 weeks + standard of care
PF-06823859
PF-06823859 IV every 4 weeks + standard of care
03
Who it enrols
Adults with active dermatomyositis or polymyositis on stable standard of care background medications, excluding those with other specific myopathies, recent severe infections, cancer, or significant cardiovascular/neurological diseases.
04
Endpoints
Primary
Total Improvement Score
Secondary
Manual Muscle Testing - 8 designated muscles
Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score
Investigator Global Assessment severity scale
Corticosteroid dose assessment
Patient-Reported Outcomes Measurement Information System - Physical Function
5-D Itch Scale Score
Functional Assessment of Chronic Illness Therapy - Fatigue
Response in corticosteroid tapering
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