A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis (SCALA)

UCB Biopharma SRL

Summary

The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.

Eligibility

Age range: 40–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion criteria: * Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF) * Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype * Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of: • long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS) * Participant at a high risk of exacerbations, defined as…

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis (SCALA)

Summary

Eligibility

Interventions

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