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A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization (BREEZE)

18. august 2026 oppdatert av: AstraZeneca

A Phase II Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

This Phase II study aims to assess the efficacy, safety, and PK of AZD0292 administered IV, as compared to placebo in participants 18 years of age and older.

The population of this study will be Chinese NCFBE patients with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options.

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Anyang, Kina, 455099
        • Rekruttering
        • Research Site
      • Beijing, Kina, 100020
        • Rekruttering
        • Research Site
      • Beijing, Kina, 100034
        • Rekruttering
        • Research Site
      • Beijing, Kina, 100730
        • Har ikke rekruttert ennå
        • Research Site
      • Changsha, Kina, 410005
        • Har ikke rekruttert ennå
        • Research Site
      • Chengdu, Kina, 610014
        • Rekruttering
        • Research Site
      • Chengdu, Kina, 611130
        • Rekruttering
        • Research Site
      • Chengdu, Kina, 610078
        • Rekruttering
        • Research Site
      • Chizhou, Kina, 247099
        • Rekruttering
        • Research Site
      • Haikou, Kina, 570311
        • Rekruttering
        • Research Site
      • Hefei, Kina, 230061
        • Rekruttering
        • Research Site
      • Hohhot, Kina, 010010
        • Har ikke rekruttert ennå
        • Research Site
      • Hohhot, Kina, 010050
        • Rekruttering
        • Research Site
      • Jinan, Kina, 250013
        • Rekruttering
        • Research Site
      • Jinhua, Kina, 321000
        • Rekruttering
        • Research Site
      • Jining, Kina, 272006
        • Har ikke rekruttert ennå
        • Research Site
      • Kunming, Kina, 650032
        • Rekruttering
        • Research Site
      • Langfang, Kina, 065000
        • Rekruttering
        • Research Site
      • Linhai, Kina, 317000
        • Rekruttering
        • Research Site
      • Liuzhou, Kina, 545006
        • Rekruttering
        • Research Site
      • Nanchang, Kina, 330006
        • Rekruttering
        • Research Site
      • Nanchang, Kina, 330000
        • Rekruttering
        • Research Site
      • Nanning, Kina, 530021
        • Rekruttering
        • Research Site
      • Shanghai, Kina, 200032
        • Rekruttering
        • Research Site
      • Shanghai, Kina, 201199
        • Rekruttering
        • Research Site
      • Shanghai, Kina, 200065
        • Rekruttering
        • Research Site
      • Shanghai, Kina, 200080
        • Har ikke rekruttert ennå
        • Research Site
      • Shanghai, Kina, 200240
        • Rekruttering
        • Research Site
      • Shenyang, Kina, 110004
        • Har ikke rekruttert ennå
        • Research Site
      • Taicang, Kina, 215400
        • Rekruttering
        • Research Site
      • Taizhou, Kina, 318000
        • Rekruttering
        • Research Site
      • Wenzhou, Kina, 325000
        • Rekruttering
        • Research Site
      • Xinxiang, Kina, 453100
        • Rekruttering
        • Research Site
      • Xuzhou, Kina, 221000
        • Rekruttering
        • Research Site
      • Zaozhuang, Kina, 277102
        • Rekruttering
        • Research Site
      • Zhangzhou, Kina, 363099
        • Rekruttering
        • Research Site
      • Zhengzhou, Kina, 450000
        • Har ikke rekruttert ennå
        • Research Site
      • Zhengzhou, Kina, 450006
        • Rekruttering
        • Research Site
      • Zhuzhou, Kina, 412007
        • Rekruttering
        • Research Site
      • Zibo, Kina, 255036
        • Rekruttering
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Participant must be ≥ 18 years of age at the time of signing the informed consent/assent.
  • Weight ≥ 35 kg.
  • Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
  • Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
  • Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
  • Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
  • Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
  • Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.
  • Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

  • Primary lung diagnosis other than bronchiectasis
  • Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
  • Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
  • Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
  • Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
  • AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)
  • History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
  • Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
  • Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
  • Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
  • Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, prior to screening.
  • Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Placebo administrert fra dag 1, påfølgende administrasjoner per plan for vurderinger.
Annen: Placebo
Placebo administrert fra dag 1 via IV -infusjon, påfølgende administrasjoner per plan for vurderinger.
Eksperimentell: AZD0292
AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
Legemiddel: AZD0292
AZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Annualized rate of exacerbations over a variable follow-up time
Tidsramme: Min 28 weeks, max 52 weeks
To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA
Min 28 weeks, max 52 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Årsatt rate av alvorlig forverring over en variabel oppfølgingstid
Tidsramme: Min 28 uker, maks 52 uker
For å evaluere effekten av AZD0292 sammenlignet med placebo på alvorlige forverringer hos deltakere med NCFBE og kronisk kolonisering med PSA
Min 28 uker, maks 52 uker
Forekomst av ADA- og ADA -titere til AZD0292
Tidsramme: Ved spesifiserte tidspunkter mellom uke 0 og endelig dose +12 uker
For å evaluere immunogenisiteten til IV -doser av AZD0292 hos deltakere med bronkiektase og kronisk kolonisering med PSA
Ved spesifiserte tidspunkter mellom uke 0 og endelig dose +12 uker
Forekomst av AES, SAES, AESIS og MAAES
Tidsramme: Forekomst av AES; Første dose til 12 uker etter administrering av inngripen for siste studieintervensjon. Forekomst av SAE -er, essens og maaer; gjennom fullføring av studier (endelig dose+24 uker)
For å vurdere sikkerheten til AZD0292 sammenlignet med placebo hos deltakere med bronkiektase og kronisk kolonisering med PSA
Forekomst av AES; Første dose til 12 uker etter administrering av inngripen for siste studieintervensjon. Forekomst av SAE -er, essens og maaer; gjennom fullføring av studier (endelig dose+24 uker)
Change from baseline in QoL-B-RSS
Tidsramme: Over the observation period (Week 0 to Last Dose+4 weeks)
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period
Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
Tidsramme: Over the observation period (Week 0 to Last Dose+4 weeks)
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.
Over the observation period (Week 0 to Last Dose+4 weeks)
Time to first moderate or severe exacerbation
Tidsramme: Time Frame: Through study completion (Final Dose +24 weeks)
To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
Time Frame: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
Tidsramme: At specified timepoints between Week 0 and Final Dose +12 weeks
To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
At specified timepoints between Week 0 and Final Dose +12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juni 2026

Primær fullføring (Antatt)

18. januar 2028

Studiet fullført (Antatt)

6. juni 2028

Datoer for studieregistrering

Først innsendt

24. juni 2026

Først innsendt som oppfylte QC-kriteriene

18. august 2026

Først lagt ut (Faktiske)

19. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • D7700C00010

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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