Phase 2RecruitingAge-related condition
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis (ZAPPHIRE)
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),in Participants With Idiopathic Pulmonary Fibrosis
- Sponsor
- Chiesi Farmaceutici S.p.A. (Industry)
- Enrolment
- 240 planned
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- CHF10067; CHF10067; Placebo
- Ages
- adults, older adults
- Registry
- NCT07516951, CTIS2024-514246-37-00
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF). 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.
Primary outcomes
- Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
History
Primary completion expected
Last registry update
Started
Registered