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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)

5 november 2026 uppdaterad av: UCB Biopharma SRL

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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • California
      • Newport Beach, California, Förenta staterna, 92663
        • Rekrytering
        • Ncfb01 50012
    • Florida
      • Brandon, Florida, Förenta staterna, 33511
        • Rekrytering
        • Ncfb01 50003
      • Plantation, Florida, Förenta staterna, 33324-7006
        • Rekrytering
        • Ncfb01 50005
    • Pennsylvania
      • DuBois, Pennsylvania, Förenta staterna, 15801
        • Rekrytering
        • Ncfb01 50004
    • South Carolina
      • Rock Hill, South Carolina, Förenta staterna, 29732
        • Rekrytering
        • Ncfb01 50007
    • Texas
      • McKinney, Texas, Förenta staterna, 75069
        • Rekrytering
        • Ncfb01 50001
      • Mesquite, Texas, Förenta staterna, 75149
        • Rekrytering
        • Ncfb01 50010

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo Arm

Participants randomly assigned to this arm will receive a matching Placebo.

Drug: Placebo Pharmaceutical form: Solution for injection

Experimentell: Galvokimig Dose 1 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 1

Drug: Galvokimig Pharmaceutical form: Solution for injection

Andra namn:
  • UCB9741
Experimentell: Galvokimig Dose 2 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 2

Drug: Galvokimig Pharmaceutical form: Solution for injection

Andra namn:
  • UCB9741
Experimentell: Galvokimig Dose 3 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 3

Drug: Galvokimig Pharmaceutical form: Solution for injection

Andra namn:
  • UCB9741

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time from intervention assignment to first moderate or severe pulmonary exacerbation
Tidsram: 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.

Up to Week 52

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
Tidsram: 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.

Up to Week 60
Incidence of TE Serious Adverse Events (SAEs)
Tidsram: 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.

Up to Week 60
Annualized rate of pulmonary exacerbations
Tidsram: 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.

Up to Week 52
Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24
Tidsram: 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.

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

At Week 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 augusti 2026

Primärt slutförande (Beräknad)

28 februari 2029

Avslutad studie (Beräknad)

26 april 2029

Studieregistreringsdatum

Först inskickad

17 juli 2026

Först inskickad som uppfyllde QC-kriterierna

17 juli 2026

Första postat (Faktisk)

22 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NCFB01
  • 2026-525524-18-00 (Ctis)
  • U1111-1337-0405 (Annan identifierare: Universal Trial Number (UTN))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .