Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo for AZD8965

    Other intervention

    Placebo for AZD8965

  • AZD8965 low dose

    Drug

    AZD8965 low dose

  • AZD8965 medium dose

    Drug

    AZD8965 medium dose

  • AZD8965 high dose

    Drug

    AZD8965 high dose

Treatment groups

359 Participants
are divided into 4 treatment groups
Group A: Placebo for AZD8965Placebo comparator 1 intervention
Group B: AZD8965 low doseExperimental treatment 1 intervention
Group C: AZD8965 medium doseExperimental treatment 1 intervention
Group D: AZD8965 high doseExperimental treatment 1 intervention

Trial outcomes

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

Time frame
at Week 24

Secondary outcomes

1

Relationship between dose and clinical efficacy of AZD8965 at Week 24

Change from baseline in FVC (in mL)

Time frame
Week 24
2

Change from baseline in FVC at Week 24

Change from baseline in % predicted FVC

Time frame
Week 24
3

Change in rate of decline in FVC at Week 24

Change in rate of decline in FVC (in mL/week)

Time frame
Week 24
4

Number of participants with adverse events (AEs)

Number of participants with AEs

Time frame
Up to 25 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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