RecruitingChronic Obstructive Pulmonary Disease With Chronic Bronchitis

A 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 (COPD) With Chronic Bronchitis

Eligible age

40–80 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: UCB Biopharma SRL

You may qualify if…

✓ 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 documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening
✓ Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening
✓ Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit
✓ Participant can be male or female.

You may not qualify if…

✕ Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
✕ Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening
✕ Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)
✕ Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior
✕ Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline
✕ Participant has clinically important pulmonary disease other than COPD with chronic bronchitis
✕ Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)
✕ Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study

Where it's recruiting

Texas

Boerne

Source: ClinicalTrials.gov · NCT07725939 · last updated 2026-08-03