Recruiting

Phase 2

GalvokimigA Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis

Sponsor:

UCB Biopharma SRL

Code:

NCT07720375

Conditions

Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex: All

Age: 18 - 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 on the time to the first pulmonary exacerbation in study participants with non-cystic fibrosis bronchiectasis (NCFB)

Conditions

Non-cystic Fibrosis Bronchiectasis

Study ID

NCT07720375

Start date

Aug 5, 2026

Status verified date

Sep, 2026

Completion date

Apr 26, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)
Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no exclusion criteria at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is randomized
Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening. If the participant is unable to produce spontaneous sputum at Screening, the participant will be considered a screening failure and may be rescreened once
Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe pulmonary exacerbation within 6 months prior to Screening
Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline
Participant has acceptable inhaler (where applicable) and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit. Participants who do not meet such criteria can be repeated once without being rescreened
Participant can be male or female
A male participant must agree to use contraception during the Intervention Period 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 (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:

Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the Intervention Period and for at least 60 days after the final dose of study intervention

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 presence or family history (first degree) of inflammatory bowel disease (IBD) (includes Crohn's disease and ulcerative colitis)
Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within 6 months prior to the Baseline, as judged by the investigator.
Participant is not permitted to enroll into the study if they meet any of the following Tuberculosis (TB) exclusion criteria:

Known active TB disease.
History of active TB involving any organ system unless adequately treated according to World Health Organization/Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consultation with an appropriate relevant specialist
Latent tuberculosis infection (LTBI) (unless a course of appropriate preventative therapy has been completed prior to study intervention dosing). TB preventive therapy should be in accordance with applicable clinical guidelines and appropriate specialist judgment based on the origin of the infection
High risk of acquiring TB infection
Participant has clinically important pulmonary disease other than NCFB as judged by the investigator.
Participant has an acute infection (including pulmonary infection) requiring antibiotics, systemic corticosteroids, or antiviral medication within 4 weeks prior to Screening (and in the Screening Period) based on the final day of antibiotic/antiviral/systemic steroid treatment or hospitalization discharge date, whichever occurred later. A participant who suffers from a pulmonary exacerbation during the Screening Period, prior to randomization, is considered a screen failure. Rescreening is allowed once following resolution of the pulmonary exacerbation
Participant has bronchiectasis known to be due to lung fibrosis, cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency disorders or α1-antitrypsin deficiency
Participant has a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma. A secondary diagnosis is allowed
Participant has significant hemoptysis defined as ≥300mL or requiring blood transfusion within 6 weeks from Screening
Participant has a history of lung transplantation
Study participant has an absolute neutrophil count (ANC) <1.5×10\^3/μL. This test can be repeated once

Study Design

Enrollment

300 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 Galvokimig Dose 1

experimental: Galvokimig Dose 2 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 2

experimental: Galvokimig Dose 3 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 3

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 intervention assignment to first moderate or severe pulmonary exacerbation [ Time Frame: Up to Week 52 ]

Central Contacts and Locations

Central contacts

UCB Cares

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

UCB Cares

0018445992273 ucbcares@ucb.com

Locations

Ncfb01 50003

Recruiting

Brandon, Florida, United States, 33511

Ncfb01 50005

Recruiting

Plantation, Florida, United States, 33324-7006

Ncfb01 50004

Recruiting

DuBois, Pennsylvania, United States, 15801

Ncfb01 50001

Recruiting

McKinney, Texas, United States, 75069

More Information

Sponsor

UCB Biopharma SRL

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

Phase 2
NCFB
ATMOS
Galvokimig
UCB9741

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by UCB Biopharma SRL on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.