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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
359
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
Relationship between dose and clinical efficacy of AZD8965 at Week 24
Change from baseline in FVC (in mL)
Time frame: Week 24
Change from baseline in FVC at Week 24
Change from baseline in % predicted FVC
Time frame: Week 24
Change in rate of decline in FVC at Week 24
Change in rate of decline in FVC (in mL/week)
Time frame: Week 24
Number of participants with adverse events (AEs)
Number of participants with AEs
Time frame: Up to 25 weeks
Number of participants with serious adverse events (SAEs)
Number of participants with SAEs
Time frame: Up to 25 weeks
Number of participants with AEs leading to discontinuation
Number of participants with AEs leading to discontinuation
Time frame: Up to 25 weeks
Summary statistics to evaluate the PK of AZD8965
AZD8965 concentrations in plasma
Time frame: From baseline to Week 24
AstraZeneca Clinical Study Information Center
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AZD8965 high dose
Research Site
Birmingham, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
RECRUITINGResearch Site
Loma Linda, California, United States
NOT_YET_RECRUITINGResearch Site
Los Angeles, California, United States
NOT_YET_RECRUITINGResearch Site
Newport Beach, California, United States
RECRUITINGResearch Site
Sacramento, California, United States
NOT_YET_RECRUITINGResearch Site
Stanford, California, United States
NOT_YET_RECRUITINGResearch Site
Aurora, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Denver, Colorado, United States
NOT_YET_RECRUITING...and 185 more locations