C0251006 - 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)
Phase 3 – large-scale trial before approval
Conditions:
Active Idiopathic Inflammatory Myopathies (Including Dermatomyositis or Polymyositis)
Sponsor: Pfizer Inc.
trial.available_in:
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Overview
Trial status: Authorised
Cohort 1 (DM): Global (except US) Change from baseline in MMT-8 score at Week 24. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) at Week 24 for participants with baseline CDASI-A score ≥14. Normalized area under the dose-time curve (AUC) of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52., Cohort 1 (DM): Global (except US): Change from baseline in PROMIS-PF at week 24. Change from baseline in 5-D Itch Scale Score at Week 24 for participants with baseline CDASI-A score ≥14. Change from baseline in FACIT-F score at Week 24., Cohort 2 (PM): Global (except US) Change from baseline in MMT-8 score at Week 24. Normalized AUC of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52. Change from baseline in PROMIS-PF at Week 24. Change from baseline in FACIT-F score at Week 24.
Cohort 1 (DM) - Global (except US): Moderate improvement in TIS at Week 24; Cohort 2 (PM) - Global (except US): Moderate improvement in TIS at Week 24
Description
Cohort 1 (DM): Global (except US) Change from baseline in MMT-8 score at Week 24. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) at Week 24 for participants with baseline CDASI-A score ≥14. Normalized area under the dose-time curve (AUC) of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52., Cohort 1 (DM): Global (except US): Change from baseline in PROMIS-PF at week 24. Change from baseline in 5-D Itch Scale Score at Week 24 for participants with baseline CDASI-A score ≥14. Change from baseline in FACIT-F score at Week 24., Cohort 2 (PM): Global (except US) Change from baseline in MMT-8 score at Week 24. Normalized AUC of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52. Change from baseline in PROMIS-PF at Week 24. Change from baseline in FACIT-F score at Week 24.
Who can participate
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 79 participants
Interventions
METHOTREXATE
Drug
PREDNISOLONE
Drug
HYDROXYCHLOROQUINE
Drug
Placebo for dazukibart 60mg/ml solution for injection
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