C6231002 - A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Phase 2 – studying effectiveness and dosage
Conditions:
Atopic Dermatitis
Sponsor: Pfizer Inc.
trial.available_in:
БГ
Overview
Trial status: Authorised
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points, Percent change from baseline in EASI total score at scheduled time points other than Week 12, Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at scheduled time points, Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS4) at scheduled time points, Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs, and electrocardiograms (ECGs)
Percent change from baseline in EASI total score at Week 12
Description
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points, Percent change from baseline in EASI total score at scheduled time points other than Week 12, Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at scheduled time points, Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus Numerical Rating Scale (PP-NRS4) at scheduled time points, Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs), and clinically significant changes in laboratory tests, vital signs, and electrocardiograms (ECGs)
Who can participate
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 49 participants