A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07652658
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo for AZD8965 — OTHER
    Placebo for AZD8965
  • AZD8965 low dose — DRUG
    AZD8965 low dose
  • AZD8965 medium dose — DRUG
    AZD8965 medium dose
  • AZD8965 high dose — DRUG
    AZD8965 high dose

Study Details

This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Sep 18, 2028
Completion
Sep 18, 2028

Study Design

Enrollment
359 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo for AZD8965
    Placebo for AZD8965
  • Experimental: AZD8965 low dose
    AZD8965 low dose
  • Experimental: AZD8965 medium dose
    AZD8965 medium dose
  • Experimental: AZD8965 high dose
    AZD8965 high dose

Primary Outcome Measure

To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24 [ Time Frame: at Week 24 ]

Central Contacts

Locations (36)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SitePhoenixArizona85006-
Research SitePhoenixArizona85032-
Research SiteLoma LindaCalifornia92350-
Research SiteLos AngelesCalifornia90033-
Research SiteNewport BeachCalifornia92663-
Research SiteSacramentoCalifornia95817-
Research SiteStanfordCalifornia94305-
Research SiteAuroraColorado80045-
Research SiteDenverColorado80206-
Research SiteOcalaFlorida34470-
Research SiteWestonFlorida33331-
Research SiteAtlantaGeorgia30322-
Research SiteBoiseIdaho83712-
Research SiteChampaignIllinois61820-
Research SiteChicagoIllinois60611-
Research SiteKansas CityKansas66160-
Research SiteLexingtonKentucky40536-
Research SiteBaltimoreMaryland21201-
Research SiteBostonMassachusetts02114-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteNew YorkNew York10017-
Research SiteNew YorkNew York10029-
Research SiteGreensboroNorth Carolina27403-
Research SiteCincinnatiOhio45267-
Research SiteOklahoma CityOklahoma73117-
Research SiteBethlehemPennsylvania18015-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19140-
Research SiteCharlestonSouth Carolina29425-
Research SiteDallasTexas75254-
Research SiteEl PasoTexas79902-
Research SiteHoustonTexas77030-
Research SiteBurlingtonVermont05401-
Research SiteRichmondVirginia23298-

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By research site
Research Site· Birmingham, ALResearch Site· Phoenix, AZResearch Site· Loma Linda, CAResearch Site· Los Angeles, CAResearch Site· Newport Beach, CAResearch Site· Sacramento, CA

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