A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants With Idiopathic Pulmonary Fibrosis (IPF) (ARGiNAUT)
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.
Inclusion Criteria:
Exclusion Criteria:
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Ciudad de Buenos Aires, C1414AIF, Argentina
North York, Ontario M2K 1E1, Canada
Wuppertal-Barmen, 42283, Germany
Hachioji-shi, 193-0998, Japan
Kakogawa-shi, 675-8611, Japan
Kumagaya-shi, 360-0197, Japan
Matsusaka-shi, 515-8544, Japan
Seto-shi, 489-8642, Japan
Shimotsuke-shi, 329-0498, Japan
Shinjuku-ku, 162-8655, Japan
Coyocan, 04330, Mexico
Parktown West, 2193, South Africa
Yunlin, 640, Taiwan