A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorAstraZeneca
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Placebo for AZD8965
- AZD8965 low dose
- AZD8965 medium dose
- AZD8965 high dose
Treatment groups
359 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov