Recruiting
Phase 2

Galvokimig

Sponsor:

UCB Biopharma SRL

Code:

NCT07725939

Conditions

Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Galvokimig

Placebo

Study Details

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

Study ID

NCT07725939

Start date

Jul 27, 2026

Status verified date

Aug, 2026

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Jun 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 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.

  • A male participant must agree to use contraception during the Intervention Periods and for at least 60 days after the final dose of study intervention and refrain from donating sperm during this period
  • A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:

  • Not a women of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the contraceptive guidance during the Intervention Periods and for at least 60 days after the final dose of study intervention
  • Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)

Exclusion criteria:

  • 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
  • Participant has relevant safety events to one or more interleukin (IL)-13 or IL-17 biologic response modifiers that resulted in discontinuation and change of treatment
  • Participant has absolute neutrophil count (ANC) <1.5 × 10³/μL
  • Participant has a corrected QT interval (QTc) >450msec for male participants or QTc >470msec for female participants or QTc >480 msec in participants with bundle branch block
  • Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 months

Study Design

Enrollment

402 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Galvokimig Dose 1 Arm

Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.

experimental: Galvokimig Dose 2 Arm

Participants randomly assigned to this arm will receive a predefined Galvokimig Dose.

placebo comparator: Placebo Arm

Participants randomly assigned to this arm will receive a matching Placebo.

Interventions

Galvokimig

Drug: Galvokimig Pharmaceutical form: Solution for injection

Placebo

Drug: Placebo Pharmaceutical form: Solution for injection

Primary outcome measure

  • Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) [ Time Frame: Up to Week 60 ]

Central Contacts and Locations

Locations

Copd01 50003

Recruiting

Columbus, Ohio, United States, 43215

Copd01 50002

Recruiting

DuBois, Pennsylvania, United States, 15801

Copd01 50001

Recruiting

Boerne, Texas, United States, 78006

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Phase 2
  • COPD
  • SCALA
  • Galvokimig
  • UCB9741
  • Chronic bronchitis
  • AECOPD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-08-27.