A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
Status: Recruiting
Location: See all (190) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Age ≥ 40 years
• IPF diagnosis
• Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care
• FVC ≥ 45% predicted of normal
• DLCO corrected for hemoglobin ≥ 25% predicted of normal
Locations
United States
Alabama
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Birmingham
Arizona
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Phoenix
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Phoenix
California
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Loma Linda
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Los Angeles
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RECRUITING
Newport Beach
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Sacramento
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Stanford
Colorado
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Aurora
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Denver
Florida
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Ocala
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Weston
Georgia
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Atlanta
Idaho
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Boise
Illinois
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Champaign
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Chicago
Kansas
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Kansas City
Kentucky
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Lexington
Massachusetts
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Boston
Maryland
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Baltimore
Michigan
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Ann Arbor
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Detroit
North Carolina
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Greensboro
New York
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New York
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New York
Ohio
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Cincinnati
Oklahoma
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Oklahoma City
Pennsylvania
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Bethlehem
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Philadelphia
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Philadelphia
South Carolina
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Charleston
Texas
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Dallas
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RECRUITING
El Paso
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Houston
Virginia
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Richmond
Vermont
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Burlington
Other Locations
Argentina
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Alberdi
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Buenos Aires
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Ciudad De Buenos Aires
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Florida
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Rosario
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San Fernando
Australia
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Port Macquarie
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Wollongong
Bulgaria
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Haskovo
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Plovdiv
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Rousse
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Sofia
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Sofia
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Sofia
Canada
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RECRUITING
Ajax
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Burlington
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RECRUITING
Kingston
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North York
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Saint-charles-borromée
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Sherbrooke
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Sherwood Park
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Vancouver
Chile
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Providencia
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Santiago
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Talca
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Viña Del Mar
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Viña Del Mar
China
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Chengdu
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Guangzhou
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Lanzhou
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Nanchang
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Nanjing
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Shanghai
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Shenyang
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Wuhan
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Xuzhou
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Zhengzhou
Denmark
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Aarhus
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Copenhagen
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Hellerup
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Odense C
France
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Angers
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Brest
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Bron
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Montpellier
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Nice
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Paris
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Rennes
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Tours
Germany
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Bonn
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Essen
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Freiburg Im Breisgau
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Fulda
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Giessen
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Hamburg
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Hanover
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Heidelberg
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Hemer
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Konstanz
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Leipzig
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Lübeck
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Marburg
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Munich
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Stuttgart
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Witten
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Wuppertal-barmen
Greece
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Athens
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Athens
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Heraklion
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Ioannina
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Pátrai
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Thessaloniki
Hungary
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Budapest
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Budapest
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Debrecen
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Törökbálint
Israel
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Ashkelon
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Jerusalem
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Kfar Saba
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Petah Tikva
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Rehovot
Italy
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Foggia
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Forlì
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Modena
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Monza
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Pavia
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Rozzano
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Siena
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Torino
Japan
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Fukuoka
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Hachioji-shi
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Hamamatsu
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Hiroshima
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Kakogawa-shi
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Kumagaya-shi
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Kumamoto
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Matsusaka-shi
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Sakaishi
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Sendai
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Seto-shi
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Shimotsuke-shi
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Shinjuku-ku
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Yokohama
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Yokohama
Mexico
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Benito Juárez
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Chihuahua City
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Coyocan
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León
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Mérida
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Monterrey
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Monterrey
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Oaxaca City
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Pachuca
Poland
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Bialystok
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Krakow
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Lodz
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Poznan
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Rzeszów
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Warsaw
Republic of Korea
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Seongnam-si
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Seoul
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Seoul
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Seoul
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Seoul
South Africa
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Cape Town
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Durban
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Parktown West
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Somerset West
Spain
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Barcelona
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Barcelona
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L'hospitalet De Llobregat
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Madrid
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Málaga
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Valencia
Taiwan
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Kaohsiung City
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Kaohsiung City
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Taichung
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Taipei
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Taipei
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Taipei
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Taoyuan
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Yunlin
United Kingdom
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Bristol
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Cottingham
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Edinburgh
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Exeter
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Liverpool
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London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-06-11
Estimated Completion Date: 2028-09-14
Participants
Target number of participants: 359
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca