NCT04631016

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Tozorakimab	Participants will receive SC injection of tozorakimab as stated in arm description.
OTHER	Placebo	Participants will receive SC injection of placebo as stated in arm description.

Timeline

• Start date: 2020-12-14
• Primary completion: 2023-05-30
• Completion: 2023-11-13
• First posted: 2020-11-16
• Last updated: 2025-02-27
• Results posted: 2025-02-27

Locations

90 sites across 15 countries: United States, Australia, Canada, Czechia, Denmark, Germany, Hungary, Israel, Netherlands, New Zealand, Poland, South Africa, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study