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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUCB Biopharma SRL

About this trial

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 criteria

Qualifiers

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 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Galvokimig
  • Placebo

Treatment groups

402 Participants
are divided into 3 treatment groups

Sponsors and collaborators