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

NCT07516951 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CHF10067

Dose 1 CHF10067 Intravenous infusion

DRUG

CHF10067

Dose 2 CHF10067 Intravenous infusion

OTHER

Placebo

Placebo Intravenous infusion

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Vincent COTTIN · Louis Pradel Hospital - Lyon, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-02-12
Completion
2028-02-12
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516951 on ClinicalTrials.gov