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

NCT07652658 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: D6960C00005
• Study Type: interventional
• Target: 359
• Locations: 22 countries
• Sites: 190

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL 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

Secondary Outcomes (7)

• Relationship between dose and clinical efficacy of AZD8965 at Week 24

  Week 24

• Change from baseline in FVC at Week 24

  Week 24

• Change in rate of decline in FVC at Week 24

  Week 24

• Number of participants with adverse events (AEs)

  Up to 25 weeks

• Number of participants with serious adverse events (SAEs)

  Up to 25 weeks

Study Arms (4)

Placebo for AZD8965

PLACEBO COMPARATOR

Placebo for AZD8965

Other: Placebo for AZD8965

AZD8965 low dose

EXPERIMENTAL

AZD8965 low dose

Drug: AZD8965 low dose

AZD8965 medium dose

EXPERIMENTAL

AZD8965 medium dose

Drug: AZD8965 medium dose

AZD8965 high dose

EXPERIMENTAL

AZD8965 high dose

Drug: AZD8965 high dose

Interventions

Placebo for AZD8965 OTHER

Placebo for AZD8965

Placebo for AZD8965

AZD8965 low dose DRUG

AZD8965 low dose

AZD8965 low dose

AZD8965 medium dose DRUG

AZD8965 medium dose

AZD8965 medium dose

AZD8965 high dose DRUG

AZD8965 high dose

AZD8965 high dose

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (190)

Research Site

Birmingham, Alabama, 35205, United States

NOT YET RECRUITING

Research Site

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

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Phoenix, Arizona, 85032, United States

NOT YET RECRUITING

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Loma Linda, California, 92350, United States

NOT YET RECRUITING

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Los Angeles, California, 90033, United States

NOT YET RECRUITING

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Newport Beach, California, 92663, United States

RECRUITING

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Sacramento, California, 95817, United States

NOT YET RECRUITING

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Stanford, California, 94305, United States

NOT YET RECRUITING

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Aurora, Colorado, 80045, United States

NOT YET RECRUITING

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Denver, Colorado, 80206, United States

NOT YET RECRUITING

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Ocala, Florida, 34470, United States

WITHDRAWN

Research Site

Weston, Florida, 33331, United States

NOT YET RECRUITING

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Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

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Boise, Idaho, 83712, United States

NOT YET RECRUITING

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Champaign, Illinois, 61820, United States

NOT YET RECRUITING

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Chicago, Illinois, 60611, United States

NOT YET RECRUITING

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Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

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Lexington, Kentucky, 40536, United States

NOT YET RECRUITING

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Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

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Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

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Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

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Detroit, Michigan, 48202, United States

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New York, New York, 10017, United States

NOT YET RECRUITING

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New York, New York, 10029, United States

NOT YET RECRUITING

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Greensboro, North Carolina, 27403, United States

NOT YET RECRUITING

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Cincinnati, Ohio, 45267, United States

NOT YET RECRUITING

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Oklahoma City, Oklahoma, 73117, United States

NOT YET RECRUITING

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Bethlehem, Pennsylvania, 18015, United States

NOT YET RECRUITING

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Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

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Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

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Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

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Dallas, Texas, 75254, United States

NOT YET RECRUITING

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El Paso, Texas, 79902, United States

RECRUITING

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Houston, Texas, 77030, United States

NOT YET RECRUITING

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Burlington, Vermont, 05401, United States

NOT YET RECRUITING

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Richmond, Virginia, 23298, United States

NOT YET RECRUITING

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Alberdi, X5033DCE, Argentina

NOT YET RECRUITING

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Buenos Aires, 1425, Argentina

NOT YET RECRUITING

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Ciudad de Buenos Aires, C1414AIF, Argentina

NOT YET RECRUITING

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Florida, B1602DQD, Argentina

NOT YET RECRUITING

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Rosario, 2000, Argentina

WITHDRAWN

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San Fernando, B1646EBJ, Argentina

NOT YET RECRUITING

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Port Macquarie, 2444, Australia

NOT YET RECRUITING

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Wollongong, 2500, Australia

NOT YET RECRUITING

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Haskovo, 6300, Bulgaria

NOT YET RECRUITING

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Plovdiv, 4001, Bulgaria

NOT YET RECRUITING

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Rousse, 7000, Bulgaria

NOT YET RECRUITING

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Sofia, 1618, Bulgaria

NOT YET RECRUITING

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Sofia, 1680, Bulgaria

NOT YET RECRUITING

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Sofia, 1756, Bulgaria

NOT YET RECRUITING

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Sherwood Park, Alberta, T8H 2M7, Canada

NOT YET RECRUITING

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Vancouver, British Columbia, V5Z 1M9, Canada

NOT YET RECRUITING

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Ajax, Ontario, L1S 2J5, Canada

RECRUITING

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Burlington, Ontario, L7N 3V2, Canada

NOT YET RECRUITING

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Kingston, Ontario, K7M 4E7, Canada

RECRUITING

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North York, Ontario, M2K 1E1, Canada

NOT YET RECRUITING

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

NOT YET RECRUITING

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Sherbrooke, Quebec, J1H 5N4, Canada

NOT YET RECRUITING

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Providencia, 7500504, Chile

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Santiago, 7750495, Chile

NOT YET RECRUITING

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Talca, 3481349, Chile

NOT YET RECRUITING

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Viña del Mar, 2531172, Chile

NOT YET RECRUITING

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Viña del Mar, 2540488, Chile

NOT YET RECRUITING

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Beijing, 100000, China

NOT YET RECRUITING

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Beijing, 100029, China

NOT YET RECRUITING

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Beijing, 100730, China

NOT YET RECRUITING

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Changchun, 130041, China

NOT YET RECRUITING

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Changsha, 430033, China

NOT YET RECRUITING

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Chengdu, 610041, China

NOT YET RECRUITING

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Chengdu, 610078, China

NOT YET RECRUITING

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Guangzhou, 510735, China

NOT YET RECRUITING

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Lanzhou, 730030, China

NOT YET RECRUITING

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Nanchang, 330000, China

NOT YET RECRUITING

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Nanjing, 2100008, China

NOT YET RECRUITING

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Shanghai, 200433, China

NOT YET RECRUITING

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Shenyang, 110015, China

WITHDRAWN

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Wuhan, 430048, China

NOT YET RECRUITING

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Xuzhou, 221000, China

NOT YET RECRUITING

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Zhengzhou, 450000, China

NOT YET RECRUITING

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Aarhus, 8200, Denmark

NOT YET RECRUITING

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Copenhagen, 2100, Denmark

NOT YET RECRUITING

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Hellerup, 2900, Denmark

NOT YET RECRUITING

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Odense C, 5000, Denmark

NOT YET RECRUITING

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Angers, 49933, France

NOT YET RECRUITING

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Brest, 29609, France

NOT YET RECRUITING

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Bron, 69677, France

NOT YET RECRUITING

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Montpellier, 34295, France

NOT YET RECRUITING

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Nice, 6000, France

NOT YET RECRUITING

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Paris, 75877, France

NOT YET RECRUITING

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Rennes, 35033, France

NOT YET RECRUITING

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Tours, 37000, France

NOT YET RECRUITING

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Bonn, 53127, Germany

NOT YET RECRUITING

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Essen, 45239, Germany

NOT YET RECRUITING

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Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

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Fulda, 36043, Germany

NOT YET RECRUITING

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Giessen, 35392, Germany

NOT YET RECRUITING

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Hamburg, 20251, Germany

NOT YET RECRUITING

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Hanover, 30459, Germany

NOT YET RECRUITING

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Heidelberg, 69126, Germany

NOT YET RECRUITING

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Hemer, 58675, Germany

NOT YET RECRUITING

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Konstanz, 78464, Germany

WITHDRAWN

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Leipzig, 04103, Germany

NOT YET RECRUITING

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Lübeck, 23538, Germany

NOT YET RECRUITING

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Marburg, 35037, Germany

NOT YET RECRUITING

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Munich, 81377, Germany

NOT YET RECRUITING

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Stuttgart, 70376, Germany

NOT YET RECRUITING

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Witten, 58452, Germany

NOT YET RECRUITING

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Wuppertal-Barmen, 42283, Germany

NOT YET RECRUITING

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Athens, 11527, Greece

NOT YET RECRUITING

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Athens, 12462, Greece

NOT YET RECRUITING

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Heraklion, 71110, Greece

NOT YET RECRUITING

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Ioannina, 45500, Greece

NOT YET RECRUITING

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Pátrai, 26500, Greece

NOT YET RECRUITING

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Thessaloniki, 57010, Greece

NOT YET RECRUITING

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Budapest, 1083, Hungary

NOT YET RECRUITING

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Budapest, 1121, Hungary

NOT YET RECRUITING

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Debrecen, 4032, Hungary

NOT YET RECRUITING

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Törökbálint, 2045, Hungary

NOT YET RECRUITING

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Ashkelon, 78278, Israel

NOT YET RECRUITING

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Jerusalem, 9103102, Israel

NOT YET RECRUITING

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Kfar Saba, 4428164, Israel

NOT YET RECRUITING

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Petah Tikva, 4941492, Israel

NOT YET RECRUITING

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Rehovot, 76100, Israel

NOT YET RECRUITING

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Foggia, 71100, Italy

NOT YET RECRUITING

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Forlì, 47121, Italy

NOT YET RECRUITING

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Modena, 41124, Italy

NOT YET RECRUITING

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Monza, 20900, Italy

NOT YET RECRUITING

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Pavia, 27100, Italy

NOT YET RECRUITING

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Rozzano, 20089, Italy

NOT YET RECRUITING

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Siena, 53100, Italy

NOT YET RECRUITING

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Torino, 10126, Italy

NOT YET RECRUITING

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Fukuoka, 810-8563, Japan

NOT YET RECRUITING

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Hachioji-shi, 193-0998, Japan

NOT YET RECRUITING

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Hamamatsu, 431-3192, Japan

NOT YET RECRUITING

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Hiroshima, 734-8530, Japan

NOT YET RECRUITING

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Kakogawa-shi, 675-8611, Japan

NOT YET RECRUITING

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Kumagaya-shi, 360-0197, Japan

NOT YET RECRUITING

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Kumamoto, 861-4193, Japan

NOT YET RECRUITING

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Matsusaka-shi, 515-8544, Japan

NOT YET RECRUITING

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Sakaishi, 591-8555, Japan

NOT YET RECRUITING

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Sendai, 980-8574, Japan

NOT YET RECRUITING

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Seto-shi, 489-8642, Japan

NOT YET RECRUITING

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Shimotsuke-shi, 329-0498, Japan

NOT YET RECRUITING

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Shinjuku-ku, 162-8655, Japan

NOT YET RECRUITING

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Yokohama, 236-0037, Japan

NOT YET RECRUITING

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Yokohama, 236-0051, Japan

NOT YET RECRUITING

Research Site

Benito Juárez, 03330, Mexico

NOT YET RECRUITING

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Chihuahua City, 31203, Mexico

NOT YET RECRUITING

Research Site

Coyocan, 04330, Mexico

NOT YET RECRUITING

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León, 37160, Mexico

NOT YET RECRUITING

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Mérida, 97130, Mexico

NOT YET RECRUITING

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Monterrey, 64460, Mexico

NOT YET RECRUITING

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Monterrey, 64465, Mexico

NOT YET RECRUITING

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Oaxaca City, 68000, Mexico

NOT YET RECRUITING

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Pachuca, 42070, Mexico

NOT YET RECRUITING

Research Site

Bialystok, 15-044, Poland

NOT YET RECRUITING

Research Site

Krakow, 31-202, Poland

WITHDRAWN

Research Site

Lodz, 90-153, Poland

NOT YET RECRUITING

Research Site

Poznan, 60-569, Poland

NOT YET RECRUITING

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Rzeszów, 35-205, Poland

NOT YET RECRUITING

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Warsaw, 02-507, Poland

NOT YET RECRUITING

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Cape Town, 7700, South Africa

NOT YET RECRUITING

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Durban, 4001, South Africa

NOT YET RECRUITING

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Parktown West, 2193, South Africa

NOT YET RECRUITING

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Somerset West, 7130, South Africa

NOT YET RECRUITING

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Seongnam-si, 13620, South Korea

NOT YET RECRUITING

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Seoul, 02841, South Korea

NOT YET RECRUITING

Research Site

Seoul, 04401, South Korea

NOT YET RECRUITING

Research Site

Seoul, 06351, South Korea

NOT YET RECRUITING

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Seoul, 5505, South Korea

NOT YET RECRUITING

Research Site

Barcelona, 08036, Spain

NOT YET RECRUITING

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Barcelona, 8025, Spain

NOT YET RECRUITING

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L'Hospitalet de Llobregat, 08907, Spain

NOT YET RECRUITING

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Madrid, 28006, Spain

NOT YET RECRUITING

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Málaga, 29010, Spain

NOT YET RECRUITING

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Valencia, 46010, Spain

NOT YET RECRUITING

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Kaohsiung City, 80756, Taiwan

NOT YET RECRUITING

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Kaohsiung City, 824, Taiwan

NOT YET RECRUITING

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Taichung, 40705, Taiwan

NOT YET RECRUITING

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Taipei, 10002, Taiwan

NOT YET RECRUITING

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Taipei, 11220, Taiwan

NOT YET RECRUITING

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Taipei, 11696, Taiwan

NOT YET RECRUITING

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Taoyuan, 333, Taiwan

NOT YET RECRUITING

Research Site

Yunlin, 640, Taiwan

NOT YET RECRUITING

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Bristol, BS105NB, United Kingdom

NOT YET RECRUITING

Research Site

Cottingham, HU16 5JQ, United Kingdom

NOT YET RECRUITING

Research Site

Edinburgh, EH16 4SA, United Kingdom

NOT YET RECRUITING

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Exeter, EX2 5DW, United Kingdom

NOT YET RECRUITING

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Liverpool, L9 7AL, United Kingdom

NOT YET RECRUITING

Research Site

London, SW3 6NP, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: June 17, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): September 14, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: 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.

Locations

DE (17); ES (6); IT (8); IL (5); KR (5); FR (8); PL (6); CL (5); ME (9); CN (16); CA (8); GB (6); DK (4); AR (6); BU (6); AU (2); GR (6); JP (15); ZA (4); HU (4); US (36); TW (8)