Non-cystic Fibrosis Bronchiectasis
Conditions
Keywords
Phase 2, NCFB, ATMOS, Galvokimig, UCB9741
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)
Interventions
BIOLOGICALGalvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
BIOLOGICALPlacebo
Drug: Placebo Pharmaceutical form: Solution for injection
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from intervention assignment to first moderate or severe pulmonary exacerbation | 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
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of pulmonary exacerbations | 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. |
| Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24 | 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. |
| Incidence of Treatment-Emergent (TE) Adverse Events (AE) | 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. |
| Incidence of TE Serious Adverse Events (SAEs) | 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. |
| Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24 | 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. |
Countries
United States
Contacts
CONTACTUCB Cares
Outcome results
None listed