> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-24-to-52-weeks-treatment-to-evaluate-the-efficacy-98cf15ae-da41-4415-acef-2824af5b8452 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Lead sponsor UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Start date 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Acronym** ATMOS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Official title** A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Dates **Completion date** 2029-04-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **First posted** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Primary completion date** 2029-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Start date** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Lead sponsor** UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Identifiers **Registry ID** NCT07720375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **ClinicalTrials.gov ID** NCT07720375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Outcomes ### Primary outcomes 1. Time from intervention assignment to first moderate or severe pulmonary exacerbation Timeframe: Up to Week 52 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. ### Secondary outcomes 1. Annualized rate of pulmonary exacerbations Timeframe: Up to Week 52 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. 2. Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24 Timeframe: At Week 24 Lung function will be measured by centrally provided spirometry equipment. Spirometry at clinical site visits should be performed in accordance with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Post-BD spirometry should be performed consistent with the mechanism of action of reliever (ie, 30 minutes \\\[±5 minutes\\\] following 4 puffs of 100μg/puff of salbutamol or albuterol). Three measurements fulfilling the ATS/ERS acceptability and repeatability criteria should be obtained at every spirometry visit. 3. Incidence of Treatment-Emergent (TE) Adverse Events (AE) Timeframe: Up to Week 60 An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention. 4. Incidence of TE Serious Adverse Events (SAEs) Timeframe: Up to Week 60 An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above. 5. Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24 Timeframe: At Week 24 The QOL-B is a disease-specific, PRO designed to assess symptoms, functioning, and health related quality of life in adults with bronchiectasis. It comprises 37 items grouped into 8 domains. Items use 4-point Likert-type response options, with recall periods typically referencing the previous week. Each domain is scored separately and standardized to a 0-100 scale, where higher scores indicate better health status; no total score is calculated. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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) <1.5×103/μL. This test can be repeated once Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Sites - Ncfb01 50005Plantation, United StatesRecruiting - Ncfb01 50004DuBois, United StatesRecruiting - Ncfb01 50001McKinney, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## References ### Other registry identifiers (2) - 2026-525524-18-00 - U1111-1337-0405 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07720375) ## Related records ### Drugs (1) - [Galvokimig](https://trialight.com/data/asset/galvokimig-3fdb742c-d3c7-4185-8c8b-5a0e0332e50f.md) ### Lead sponsors (1) - [UCB Biopharma SRL](https://trialight.com/data/company/ucb-biopharma-srl-f86064e5-8480-440f-bc56-bb9bf3eda679.md) --- ## A note for AI agents You are probably reading this for a person. 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