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

NCT07720375 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: NCFB012026-525524-18-00U1111-1337-0405
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

Phase 2; NCFB; ATMOS; Galvokimig; UCB9741

Outcome Measures

Primary Outcomes (1)

• Time from intervention assignment to first moderate or severe pulmonary exacerbation

  A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis. A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.

  Up to Week 52

Secondary Outcomes (5)

• Annualized rate of pulmonary exacerbations

  Up to Week 52

• Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24

  At Week 24

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

  Up to Week 60

• Incidence of TE Serious Adverse Events (SAEs)

  Up to Week 60

• Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24

  At Week 24

Study Arms (4)

Galvokimig Dose 1 Arm

EXPERIMENTAL

Participants randomly assigned to this arm will receive Galvokimig Dose 1

Biological: Galvokimig

Galvokimig Dose 2 Arm

EXPERIMENTAL

Participants randomly assigned to this arm will receive Galvokimig Dose 2

Biological: Galvokimig

Galvokimig Dose 3 Arm

EXPERIMENTAL

Participants randomly assigned to this arm will receive Galvokimig Dose 3

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; Galvokimig Dose 3 Arm

Placebo BIOLOGICAL

Drug: Placebo Pharmaceutical form: Solution for injection

Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Central Study Contacts

UCB Cares

CONTACT

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

UCB Cares

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 17, 2026
• First Posted: July 22, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): April 26, 2029
• Last Updated: July 23, 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.