Phase IIb Study Evaluating Safety and Effectiveness of Two Doses of CHF10067 Zampilimab Infusions for Adults with Idiopathic Pulmonary Fibrosis

What this Trial Is About

Researchers are evaluating two different doses of CHF10067 zampilimab to assess their effectiveness, safety, and tolerability in adults with idiopathic pulmonary fibrosis IPF. This phase IIb, multicenter, randomized, double-blind, placebo-controlled study involves 240 participants across about 150 sites worldwide. The study focuses on changes in lung function, specifically percent predicted forced vital capacity ppFVC, at Week 24. Participants will be randomly assigned to one of three groups receiving either one of two doses of CHF10067 or a placebo, all administered via intravenous infusion. The study treatment is given over a 24-week period, with evaluations at several points including Weeks 6, 12, 18, 24, and 30. This design allows comparison of the drug doses against placebo while monitoring drug levels and effects over time. During the study, participants will undergo lung function tests, oxygen saturation measurements, and complete questionnaires related to living with pulmonary fibrosis. Blood samples will be taken to measure drug concentration. Various outcome measures such as absolute and relative changes in lung function and symptom assessments will be collected up to Week 30. Safety and tolerability will be closely monitored throughout the study period.

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