Recruiting NCT07652658

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

Phase II Interventional Idiopathic Pulmonary Fibrosis (IPF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Placebo for AZD8965, AZD8965 low dose, AZD8965 medium dose, AZD8965 high dose.
Who it may be relevant to: Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: from 40 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Bulgaria, Canada +17
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

Other Placebo for AZD8965
Placebo for AZD8965
Drug AZD8965 low dose
AZD8965 low dose
Drug AZD8965 medium dose
AZD8965 medium dose
Drug AZD8965 high dose
AZD8965 high dose

Primary outcome measures

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]

Secondary outcome measures (7)

Relationship between dose and clinical efficacy of AZD8965 at Week 24 [Time frame: Week 24]
Change from baseline in FVC at Week 24 [Time frame: Week 24]
Change in rate of decline in FVC at Week 24 [Time frame: Week 24]
Number of participants with adverse events (AEs) [Time frame: Up to 25 weeks]
Number of participants with serious adverse events (SAEs) [Time frame: Up to 25 weeks]
Number of participants with AEs leading to discontinuation [Time frame: Up to 25 weeks]
Summary statistics to evaluate the PK of AZD8965 [Time frame: From baseline to Week 24]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment