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 (ATMOS)
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)
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)
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: UCB Cares
- Telefonní číslo: 1-844-599-2273 (USA)
- E-mail: ucbcares@ucb.com
Studijní záloha kontaktů
- Jméno: UCB Cares
- Telefonní číslo: 0018445992273
- E-mail: ucbcares@ucb.com
Studijní místa
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California
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Newport Beach, California, Spojené státy, 92663
- Nábor
- Ncfb01 50012
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Florida
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Brandon, Florida, Spojené státy, 33511
- Nábor
- Ncfb01 50003
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Plantation, Florida, Spojené státy, 33324-7006
- Nábor
- Ncfb01 50005
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Pennsylvania
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DuBois, Pennsylvania, Spojené státy, 15801
- Nábor
- Ncfb01 50004
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South Carolina
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Rock Hill, South Carolina, Spojené státy, 29732
- Nábor
- Ncfb01 50007
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Texas
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McKinney, Texas, Spojené státy, 75069
- Nábor
- Ncfb01 50001
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Mesquite, Texas, Spojené státy, 75149
- Nábor
- Ncfb01 50010
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)
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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
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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
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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
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Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline
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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
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Participant can be male or female
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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
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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:
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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
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Participant has a presence or family history (first degree) of inflammatory bowel disease (IBD) (includes Crohn's disease and ulcerative colitis)
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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.
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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
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Participant has clinically important pulmonary disease other than NCFB as judged by the investigator.
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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
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Participant has bronchiectasis known to be due to lung fibrosis, cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency disorders or α1-antitrypsin deficiency
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Participant has a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma. A secondary diagnosis is allowed
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Participant has significant hemoptysis defined as ≥300mL or requiring blood transfusion within 6 weeks from Screening
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Participant has a history of lung transplantation
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Study participant has an absolute neutrophil count (ANC) <1.5×10^3/μL. This test can be repeated once
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Komparátor placeba: Placebo Arm
Participants randomly assigned to this arm will receive a matching Placebo. |
Drug: Placebo Pharmaceutical form: Solution for injection |
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Experimentální: Galvokimig Dose 1 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 1 |
Drug: Galvokimig Pharmaceutical form: Solution for injection
Ostatní jména:
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Experimentální: Galvokimig Dose 2 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 2 |
Drug: Galvokimig Pharmaceutical form: Solution for injection
Ostatní jména:
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Experimentální: Galvokimig Dose 3 Arm
Participants randomly assigned to this arm will receive Galvokimig Dose 3 |
Drug: Galvokimig Pharmaceutical form: Solution for injection
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time from intervention assignment to first moderate or severe pulmonary exacerbation
Časové okno: Up to Week 52
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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
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Treatment-Emergent (TE) Adverse Events (AE)
Časové okno: Up to Week 60
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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. |
Up to Week 60
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Incidence of TE Serious Adverse Events (SAEs)
Časové okno: Up to Week 60
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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. |
Up to Week 60
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Annualized rate of pulmonary exacerbations
Časové okno: Up to Week 52
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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
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Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24
Časové okno: At Week 24
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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. |
At Week 24
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Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24
Časové okno: At Week 24
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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. |
At Week 24
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
Další identifikační čísla studie
- NCFB01
- 2026-525524-18-00 (Ctis)
- U1111-1337-0405 (Jiný identifikátor: Universal Trial Number (UTN))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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