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NOT YET RECRUITING
NCT07516951
PHASE2

A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis

Sponsor: Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

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

Interventions

DRUG

CHF10067

Dose 1 CHF10067 Intravenous infusion

DRUG

CHF10067

Dose 2 CHF10067 Intravenous infusion

OTHER

Placebo

Placebo Intravenous infusion