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

NCT07725939 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: COPD012026-525523-25-00U1111-1337-0331
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

  AECOPD will be defined as a worsening in the study participants' usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days (or less if the worsening is so rapid and profound that the treating physician judges that intensification of treatment cannot be delayed). Moderate AECOPD require use of systemic corticosteroids and/or antibiotics for at least 3 consecutive days; Severe AECOPD is an AECOPD requiring a hospitalization for \>= 24 hours or leading to a COPD-related death.

  Up to Week 60

Secondary Outcomes (6)

• Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at 24 weeks

  At Week 24

• Annualized rate of moderate and severe AECOPD up to End of Treatment

  From Baseline up to Week 52

• Change from Baseline at Week 24 in St. George's Respiratory Questionnaire-COPD-specific version (SGRQ-C)

  At Week 24

• Proportion of participants with a decrease in SGRQ C total score of ≥4 points from Baseline to Week 24

  From Baseline up to Week 24

• Incidence of Treatment-Emergent (TE) Adverse Events (AE)

  Up to Week 60

Study Arms (3)

Galvokimig Dose 1 Arm

EXPERIMENTAL

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

Biological: Galvokimig

Galvokimig Dose 2 Arm

EXPERIMENTAL

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

Biological: Galvokimig

Placebo Arm

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Galvokimig BIOLOGICAL

Drug: Galvokimig Pharmaceutical form: Solution for injection

Also known as: UCB9741

Galvokimig Dose 1 Arm; Galvokimig Dose 2 Arm

Placebo BIOLOGICAL

Drug: Placebo Pharmaceutical form: Solution for injection

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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)

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
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Central Study Contacts

UCB Cares

CONTACT

1-844-599-2273 (USA); ucbcares@ucb.com

UCB Care

CONTACT

0018445992273; ucbcares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.