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

Sponsor
Chiesi Farmaceutici S.p.A.
Study ID
NCT07516951
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHF10067 — DRUG
    Dose 1 CHF10067 Intravenous (IV) infusion
  • CHF10067 — DRUG
    Dose 2 CHF10067 IV infusion
  • Placebo — OTHER
    Placebo IV infusion

Study Details

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.

Key Dates

First listed
Apr 8, 2026
Start date
Jul 8, 2026
Status verified
Jul 2026
Primary completion
Feb 12, 2028
Completion
Feb 12, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    CHF10067 (Test Dose 1)
  • Experimental: Arm B
    CHF10067 (Test Dose 2)
  • Placebo Comparator: Arm C
    Placebo

Primary Outcome Measure

Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24. [ Time Frame: At Week 24 ]

Central Contacts

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