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

NCT07652658 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2026-06-25

No results posted yet for this study

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)

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2028-09-14
Completion
2028-09-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Chile
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652658 on ClinicalTrials.gov