Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

11. juni 2026 opdateret af: AstraZeneca

A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

359

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Argentina
      • Alberdi, Argentina, X5033DCE
        • Research Site
      • Buenos Aires, Argentina, 1425
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1414AIF
        • Research Site
      • Florida, Argentina, B1602DQD
        • Research Site
      • Rosario, Argentina, 2000
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Research Site
  • Australien
      • Port Macquarie, Australien, 2444
        • Research Site
      • Wollongong, Australien, 2500
        • Research Site
  • Bulgarien
      • Haskovo, Bulgarien, 6300
        • Research Site
      • Plovdiv, Bulgarien, 4001
        • Research Site
      • Rousse, Bulgarien, 7000
        • Research Site
      • Sofia, Bulgarien, 1756
        • Research Site
      • Sofia, Bulgarien, 1618
        • Research Site
      • Sofia, Bulgarien, 1680
        • Research Site
  • Canada
    • Alberta
      • Sherwood Park, Alberta, Canada, T8H 2M7
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Burlington, Ontario, Canada, L7N 3V2
        • Research Site
      • Kingston, Ontario, Canada, K7M 4E7
        • Research Site
      • North York, Ontario, Canada, M2K 1E1
        • Research Site
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • Chile
      • Providencia, Chile, 7500504
        • Research Site
      • Santiago, Chile, 7750495
        • Research Site
      • Talca, Chile, 3481349
        • Research Site
      • Viña del Mar, Chile, 2540488
        • Research Site
      • Viña del Mar, Chile, 2531172
        • Research Site
  • Danmark
      • Aarhus, Danmark, 8200
        • Research Site
      • Copenhagen, Danmark, 2100
        • Research Site
      • Hellerup, Danmark, 2900
        • Research Site
      • Odense C, Danmark, 5000
        • Research Site
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS105NB
        • Research Site
      • Cottingham, Det Forenede Kongerige, HU16 5JQ
        • Research Site
      • Edinburgh, Det Forenede Kongerige, EH16 4SA
        • Research Site
      • Exeter, Det Forenede Kongerige, EX2 5DW
        • Research Site
      • Liverpool, Det Forenede Kongerige, L9 7AL
        • Research Site
      • London, Det Forenede Kongerige, SW3 6NP
        • Research Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Research Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Research Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Research Site
    • California
      • Loma Linda, California, Forenede Stater, 92350
        • Research Site
      • Los Angeles, California, Forenede Stater, 90033
        • Research Site
      • Newport Beach, California, Forenede Stater, 92663
        • Research Site
      • Sacramento, California, Forenede Stater, 95817
        • Research Site
      • Stanford, California, Forenede Stater, 94305
        • Research Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Research Site
      • Denver, Colorado, Forenede Stater, 80206
        • Research Site
    • Florida
      • Ocala, Florida, Forenede Stater, 34470
        • Research Site
      • Weston, Florida, Forenede Stater, 33331
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Research Site
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Research Site
    • Illinois
      • Champaign, Illinois, Forenede Stater, 61820
        • Research Site
      • Chicago, Illinois, Forenede Stater, 60611
        • Research Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Research Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Research Site
      • Detroit, Michigan, Forenede Stater, 48202
        • Research Site
    • New York
      • New York, New York, Forenede Stater, 10029
        • Research Site
      • New York, New York, Forenede Stater, 10017
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73117
        • Research Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Research Site
    • Texas
      • Dallas, Texas, Forenede Stater, 75254
        • Research Site
      • El Paso, Texas, Forenede Stater, 79902
        • Research Site
      • Houston, Texas, Forenede Stater, 77030
        • Research Site
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Research Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Research Site
  • Frankrig
      • Angers, Frankrig, 49933
        • Research Site
      • Brest, Frankrig, 29609
        • Research Site
      • Bron, Frankrig, 69677
        • Research Site
      • Montpellier, Frankrig, 34295
        • Research Site
      • Nice, Frankrig, 6000
        • Research Site
      • Paris, Frankrig, 75877
        • Research Site
      • Rennes, Frankrig, 35033
        • Research Site
      • Tours, Frankrig, 37000
        • Research Site
  • Grækenland
      • Athens, Grækenland, 11527
        • Research Site
      • Athens, Grækenland, 12462
        • Research Site
      • Heraklion, Grækenland, 71110
        • Research Site
      • Ioannina, Grækenland, 45500
        • Research Site
      • Pátrai, Grækenland, 26500
        • Research Site
      • Thessaloniki, Grækenland, 57010
        • Research Site
  • Israel
      • Ashkelon, Israel, 78278
        • Research Site
      • Jerusalem, Israel, 9103102
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Research Site
      • Rehovot, Israel, 76100
        • Research Site
  • Italien
      • Foggia, Italien, 71100
        • Research Site
      • Forlì, Italien, 47121
        • Research Site
      • Modena, Italien, 41124
        • Research Site
      • Monza, Italien, 20900
        • Research Site
      • Pavia, Italien, 27100
        • Research Site
      • Rozzano, Italien, 20089
        • Research Site
      • Siena, Italien, 53100
        • Research Site
      • Torino, Italien, 10126
        • Research Site
  • Japan
      • Fukuoka, Japan, 810-8563
        • Research Site
      • Hachioji-shi, Japan, 193-0998
        • Research Site
      • Hamamatsu, Japan, 431-3192
        • Research Site
      • Hiroshima, Japan, 734-8530
        • Research Site
      • Kakogawa-shi, Japan, 675-8611
        • Research Site
      • Kumagaya-shi, Japan, 360-0197
        • Research Site
      • Kumamoto, Japan, 861-4193
        • Research Site
      • Matsusaka-shi, Japan, 515-8544
        • Research Site
      • Sakaishi, Japan, 591-8555
        • Research Site
      • Sendai, Japan, 980-8574
        • Research Site
      • Seto-shi, Japan, 489-8642
        • Research Site
      • Shimotsuke-shi, Japan, 329-0498
        • Research Site
      • Shinjuku-ku, Japan, 162-8655
        • Research Site
      • Yokohama, Japan, 236-0037
        • Research Site
      • Yokohama, Japan, 236-0051
        • Research Site
  • Kina
      • Beijing, Kina, 100730
        • Research Site
      • Beijing, Kina, 100029
        • Research Site
      • Beijing, Kina, 100000
        • Research Site
      • Changchun, Kina, 130041
        • Research Site
      • Changsha, Kina, 430033
        • Research Site
      • Chengdu, Kina, 610041
        • Research Site
      • Chengdu, Kina, 610078
        • Research Site
      • Guangzhou, Kina, 510735
        • Research Site
      • Lanzhou, Kina, 730030
        • Research Site
      • Nanchang, Kina, 330000
        • Research Site
      • Nanjing, Kina, 2100008
        • Research Site
      • Shanghai, Kina, 200433
        • Research Site
      • Shenyang, Kina, 110015
        • Research Site
      • Wuhan, Kina, 430048
        • Research Site
      • Xuzhou, Kina, 221000
        • Research Site
      • Zhengzhou, Kina, 450000
        • Research Site
  • Mexico
      • Benito Juárez, Mexico, 03330
        • Research Site
      • Chihuahua City, Mexico, 31203
        • Research Site
      • Coyocan, Mexico, 04330
        • Research Site
      • León, Mexico, 37160
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Monterrey, Mexico, 64465
        • Research Site
      • Mérida, Mexico, 97130
        • Research Site
      • Oaxaca City, Mexico, 68000
        • Research Site
      • Pachuca, Mexico, 42070
        • Research Site
  • Polen
      • Bialystok, Polen, 15-044
        • Research Site
      • Krakow, Polen, 31-202
        • Research Site
      • Lodz, Polen, 90-153
        • Research Site
      • Poznan, Polen, 60-569
        • Research Site
      • Rzeszów, Polen, 35-205
        • Research Site
      • Warsaw, Polen, 02-507
        • Research Site
  • Spanien
      • Barcelona, Spanien, 08036
        • Research Site
      • Barcelona, Spanien, 8025
        • Research Site
      • L'Hospitalet de Llobregat, Spanien, 08907
        • Research Site
      • Madrid, Spanien, 28006
        • Research Site
      • Málaga, Spanien, 29010
        • Research Site
      • Valencia, Spanien, 46010
        • Research Site
  • Sydafrika
      • Cape Town, Sydafrika, 7700
        • Research Site
      • Durban, Sydafrika, 4001
        • Research Site
      • Parktown West, Sydafrika, 2193
        • Research Site
      • Somerset West, Sydafrika, 7130
        • Research Site
  • Sydkorea
      • Seongnam-si, Sydkorea, 13620
        • Research Site
      • Seoul, Sydkorea, 02841
        • Research Site
      • Seoul, Sydkorea, 06351
        • Research Site
      • Seoul, Sydkorea, 5505
        • Research Site
      • Seoul, Sydkorea, 04401
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Research Site
      • Kaohsiung City, Taiwan, 824
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11220
        • Research Site
      • Taipei, Taiwan, 11696
        • Research Site
      • Taoyuan, Taiwan, 333
        • Research Site
      • Yunlin, Taiwan, 640
        • Research Site
  • Tyskland
      • Bonn, Tyskland, 53127
        • Research Site
      • Essen, Tyskland, 45239
        • Research Site
      • Freiburg im Breisgau, Tyskland, 79106
        • Research Site
      • Fulda, Tyskland, 36043
        • Research Site
      • Giessen, Tyskland, 35392
        • Research Site
      • Hamburg, Tyskland, 20251
        • Research Site
      • Hanover, Tyskland, 30459
        • Research Site
      • Heidelberg, Tyskland, 69126
        • Research Site
      • Hemer, Tyskland, 58675
        • Research Site
      • Konstanz, Tyskland, 78464
        • Research Site
      • Leipzig, Tyskland, 04103
        • Research Site
      • Lübeck, Tyskland, 23538
        • Research Site
      • Marburg, Tyskland, 35037
        • Research Site
      • Munich, Tyskland, 81377
        • Research Site
      • Stuttgart, Tyskland, 70376
        • Research Site
      • Witten, Tyskland, 58452
        • Research Site
      • Wuppertal-Barmen, Tyskland, 42283
        • Research Site
  • Ungarn
      • Budapest, Ungarn, 1083
        • Research Site
      • Budapest, Ungarn, 1121
        • Research Site
      • Debrecen, Ungarn, 4032
        • Research Site
      • Törökbálint, Ungarn, 2045
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 40 years
  2. IPF diagnosis
  3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care
  4. FVC ≥ 45% predicted of normal
  5. DLCO corrected for hemoglobin ≥ 25% predicted of normal

Exclusion Criteria:

  1. ILD other than IPF
  2. The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan
  3. Acute exacerbation of IPF
  4. Lower respiratory tract infection requiring treatment
  5. Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting
  6. Heart failure
  7. History of organ transplantation or is likely to receive lung transplantation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo for AZD8965
Andet: Placebo for AZD8965
Placebo for AZD8965
Eksperimentel: AZD8965 low dose
Medicin: AZD8965 low dose
AZD8965 low dose
Eksperimentel: AZD8965 medium dose
Medicin: AZD8965 medium dose
AZD8965 medium dose
Eksperimentel: AZD8965 high dose
Medicin: AZD8965 high dose
AZD8965 high dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
Tidsramme: at Week 24
To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24
at Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relationship between dose and clinical efficacy of AZD8965 at Week 24
Tidsramme: Week 24
Change from baseline in FVC (in mL)
Week 24
Change from baseline in FVC at Week 24
Tidsramme: Week 24
Change from baseline in % predicted FVC
Week 24
Change in rate of decline in FVC at Week 24
Tidsramme: Week 24
Change in rate of decline in FVC (in mL/week)
Week 24
Number of participants with adverse events (AEs)
Tidsramme: Up to 25 weeks
Number of participants with AEs
Up to 25 weeks
Number of participants with serious adverse events (SAEs)
Tidsramme: Up to 25 weeks
Number of participants with SAEs
Up to 25 weeks
Number of participants with AEs leading to discontinuation
Tidsramme: Up to 25 weeks
Number of participants with AEs leading to discontinuation
Up to 25 weeks
Summary statistics to evaluate the PK of AZD8965
Tidsramme: From baseline to Week 24
AZD8965 concentrations in plasma
From baseline to Week 24

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

18. september 2028

Studieafslutning (Anslået)

18. september 2028

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D6960C00005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo for AZD8965

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner