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

Study acronym: ZAPPHIRE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Feb 12, 2028 → Jun 27, 2028
See other at-risk trials from Chiesi Farmaceutici S.p.A.

Record History

  1. Study sites: 2 to 3 Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 2 of 11 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 11 entries
  2. Primary and study completion pushed from Feb 12, 2028 to Jun 27, 2028 Study sites: 1 to 2v3 Show 1 more changeShow less
    • Study sites: 1 to 2
  3. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2026 to Jul 8, 2026 · Secondary endpoints revised (11) · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2026 to Jul 8, 2026
    • Secondary endpoints revised (11)
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07516951
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Idiopathic Pulmonary Fibrosis
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov