臨床研究等提出・公開システム

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Date of registration	July. 13, 2026
Last modified on	July. 13, 2026
Trial ID	jRCT2041260087

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

Contact for Scientific Queries	Name	Tsugumi Hirotaka
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com
Contact for Public Queries	Name	Tsugumi Hirotaka
	Affiliation	Astrazeneka K.K
	Address	3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka
	Telephone	+81-6-4802-3600
	E-mail	RD-clinical-information-Japan@astrazeneca.com

Recruitment status	Pending

Anticipated date of first enrollment		Aug. 14, 2026
Target sample size		18
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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 Interv ention, or Coronary Artery Bypass Grafting 6. Heart failure 7. History of organ transplantation or is likely to receive lung transplantation
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Idiopathic Pulmonary Fibrosis (IPF)
Intervention(s)		Intervention name: AZD8965 Description: AZD8965 administered oraly throughout the study. Intervention Name: Placebo Description: Placebo administered oraly throughout the study.
Primary Outcome(s)		To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24

Primary Sponsor	Astrazeneca K.K

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Saiseikai Matsusaka Municipal Hospital IRB
Address	1550 Tonomachi, Matsusaka, Mie, Mie
Telephone	+81-598-23-1515
E-Mail	mchkytks@city-hosp.matsusaka.mie.jp
Approval Status	Approval
Date of approval	July. 10, 2026

Plan to share IPD	Yes
Plan description	Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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.

Plan to share IPD

Yes

Plan description

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

Secondary ID(s)	NCT07652658
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Argentina/Australia/Bulgaria/Canda/Chile/China/Denmark/France/Germany/Greee/Hungary/Israel/Italy/Mexico/the Netherlands/Poland/South Africa/South Korea/Spain/Taiwan/the United Kingdom/the United States