CHF10067 for Idiopathic Pulmonary Fibrosis
(ZAPPHIRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CHF10067, or zampilimab, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to assess the treatment's effectiveness and safety after 24 weeks. Participants will be divided into three groups: two groups will receive different doses of the treatment, and one group will receive a placebo (a substance with no active drug). Individuals with a confirmed IPF diagnosis for up to 8 years and who experience breathing difficulties might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies showed that zampilimab, also known as CHF10067, was well tolerated by participants. No deaths or serious side effects led to treatment discontinuation. Participants did not experience major problems from using zampilimab. Notably, these studies tested various doses, and no major safety issues emerged at any level. This suggests that zampilimab is generally safe for use.12345
Why are researchers excited about this trial's treatments?
Most treatments for idiopathic pulmonary fibrosis, like pirfenidone and nintedanib, aim to slow down lung scarring but don't significantly improve lung function. Zampilimab (CHF10067) is different because it targets an innovative pathway that could potentially reduce inflammation and fibrosis more effectively. Researchers are excited because this new mechanism might not only slow disease progression but also improve patients' lung function and quality of life, offering hope beyond the current standard of care.
What evidence suggests that this trial's treatments could be effective for idiopathic pulmonary fibrosis?
This trial will evaluate CHF10067 (Zampilimab) for idiopathic pulmonary fibrosis (IPF). Participants will join different arms, including two experimental arms with varying doses of Zampilimab and a placebo comparator arm. Studies have shown that Zampilimab can significantly improve lung function in people with IPF. Specifically, early results suggest that this treatment enhances lung performance and improves certain lung test results after 24 weeks. Research indicates that Zampilimab targets the lung scarring process, crucial for managing IPF. Overall, these early findings offer promise for those facing this challenging condition.13467
Who Is on the Research Team?
Vincent COTTIN
Principal Investigator
Louis Pradel Hospital - Lyon, FRANCE
Are You a Good Fit for This Trial?
This trial is for men and women aged 40 or older who have been diagnosed with idiopathic pulmonary fibrosis (IPF) within the last 8 years. Participants need to have certain levels of lung function, weigh at least 45 kg, and be expected to live at least one more year.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either CHF10067 (Zampilimab) or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CHF10067 (Zampilimab)
Trial Overview
The study is testing two different doses of a new drug called CHF10067 (zampilimab) compared to a placebo in people with IPF. Participants are randomly assigned to one of three groups, and neither they nor their doctors know which treatment they're getting.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
CHF10067 (Test Dose 2)
CHF10067 (Test Dose 1)
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chiesi Farmaceutici S.p.A.
Lead Sponsor
Citations
A Study to Find an Efficacious and Safe Dose of CHF10067 ...
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 ...
Chiesi Clinical TrialsTrial ID CLI-10067AA1-02
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 ...
ZAMPILIMAB – Application in Therapy and Current Clinical ...
The trial is for participants with idiopathic pulmonary fibrosis. IPF is a lung disease that causes scarring and can reduce breathing ability; the trial data do ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/250236b182c96df9/nct07516951-chf10067-zampilimab-idiopathic-pulmonary-fibrosis-efficacyA Study to Find an Efficacious and Safe... | Clinical Trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067
zampilimab (UCB7858) / UCB
ampilimab can significantly improve lung function and micro-CT–derived functional biomarkers. A Study to Find an Efficacious and Safe Dose of CHF10067 ( ...
Safety, Tolerability, and Pharmacokinetics of CHF10067 in ...
Zampilimab was well tolerated at all dose levels, with no deaths or treatment-emergent adverse events (TEAEs) leading to discontinuation.
A Study to Investigate the Safety, Tolerability, and ...
The principal aim of this study was to obtain safety and tolerability data when CHF10067 was administered intravenously as single ascending ...
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