Completed
PHASE2
INTERVENTIONAL
NCT04631016
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult participants with Chronic Obstructive Pulmonary Disease and Chronic Bronchitis.
Detailed Description
Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis. Approximately 85 sites globally will participate in this study. Approximately 144 participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or placebo.
Interventions
Name:
Tozorakimab
Type:
DRUG
Description:
Participants will receive SC injection of tozorakimab as stated in arm description.
Name:
Placebo
Type:
OTHER
Description:
Participants will receive SC injection of placebo as stated in arm description.
Primary Outcomes
Measure:
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
TimeFrame:
Baseline (Day -35 to Day -28) through Week 12
Description:
The mean change from baseline in Pre-BD FEV1 at Week 12 (tozorakimab - placebo) estimated using a repeated measures mixed effects analysis of covariance measures was estimated. Data available from all visits up to and including Week 12, irrespective of whether the participant discontinued study drug or received reliever therapy was considered. FEV1 was measured by spirometry at clinic.
Trial Information
NCT ID
NCT04631016
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
AstraZeneca
Last Updated
December 15, 2025