Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Brief 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.
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
OTHERPlacebo for AZD8965
Placebo for AZD8965
DRUGAZD8965 low dose
AZD8965 low dose
DRUGAZD8965 medium dose
AZD8965 medium dose
DRUGAZD8965 high dose
AZD8965 high dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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 Intervention, or Coronary Artery Bypass Grafting 6. Heart failure 7. History of organ transplantation or is likely to receive lung transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the clinical efficacy of AZD8965 compared with placebo on the absolute change from baseline in FVC in mL at Week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between dose and clinical efficacy of AZD8965 at Week 24 | Week 24 | Change from baseline in FVC (in mL) |
| Change from baseline in FVC at Week 24 | Week 24 | Change from baseline in % predicted FVC |
| Change in rate of decline in FVC at Week 24 | Week 24 | Change in rate of decline in FVC (in mL/week) |
| Number of participants with adverse events (AEs) | Up to 25 weeks | Number of participants with AEs |
| Number of participants with serious adverse events (SAEs) | Up to 25 weeks | Number of participants with SAEs |
| Number of participants with AEs leading to discontinuation | Up to 25 weeks | Number of participants with AEs leading to discontinuation |
| Summary statistics to evaluate the PK of AZD8965 | From baseline to Week 24 | AZD8965 concentrations in plasma |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, China, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Poland, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed