PF-07275315 in People with Moderate-to-Very Severe Pulmonary Disease
Research type
Research Study
Full title
AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLELGROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
IRAS ID
1012475
Contact name
Mary-Ellen Boers
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2024-518587-12
Clinicaltrials.gov Identifier
Research summary
An Interventional Phase 2/3, Randomized, Double-Blind, Third Party-Unblinded, Placebo Controlled, Parallel-Group, Study to Investigate Efficacy and Safety of PF-07275315 in Adult Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD).
Rationale: Study C4531031 is a Phase 2/3 study with the objectives to evaluate the efficacy and safety of PF-07275315 compared to placebo in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study will be conducted in 2 independent stages corresponding to the phase of development: Phase 2 (Stage 1) and Phase 3 (Stage 2). The study will also evaluate the pharmacokinetics (PK), immunogenicity, and biomarkers related to PF-07275315 in both phases.
The information presented throughout this protocol applies to both Phase 2 and Phase 3 stages of the study, unless otherwise specified.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0084
Date of REC Opinion
11 May 2026
REC opinion
Further Information Favourable Opinion