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A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
Sponsor: Chiesi Farmaceutici S.p.A.
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 (Part A) of 2 doses of CHF10067 (zampilimab), with an optional 24-week double-blind, placebo-controlled extension phase (Part B) in participants with idiopathic pulmonary fibrosis. It is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study. A total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania. The optional extension phase (Part B) is only applicable to the European Union and Macedonia.
Official title: A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab), With an Optional 24-week Double Blind, Placebo Controlled Extension Phase in Participants With Idiopathic Pulmonary Fibrosis
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-06-01
Completion Date
2028-02-12
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
CHF10067
Dose 1 CHF10067 Intravenous infusion
CHF10067
Dose 2 CHF10067 Intravenous infusion
Placebo
Placebo Intravenous infusion