240 Participants NeededMy employer runs this trial

CHF10067 for Idiopathic Pulmonary Fibrosis

(ZAPPHIRE Trial)

Recruiting at 2 trial locations
CC
Overseen ByChiesi Clinical Trial Info
Prior Safety DataThis treatment has passed at least one previous human 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?

VC

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

Participant's written informed consent obtained prior to any study-related procedure
DLCO corrected for haemoglobin ≥25% of predicted normal at screening
Oxygen saturation (SpO2) >90% at rest with maximum oxygen flow 4 L/min by standard nasal cannula or equivalent oxygen delivery via reservoir nasal cannula (≤2 L/min)
See 4 more

Exclusion Criteria

HRCT showing emphysema ≥20% or extent of emphysema greater than extent of fibrosis reviewed by central reading
I have been diagnosed with coeliac disease.
Known intolerance and/or hypersensitivity to any excipients in the formulation or any other substance used in the study
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CHF10067 (Zampilimab) or placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Arm BExperimental Treatment1 Intervention
Group II: Arm AExperimental Treatment1 Intervention
Group III: Arm CPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chiesi Farmaceutici S.p.A.

Lead Sponsor

Trials
206
Recruited
315,000+
Founded
1935
Headquarters
Parma, Italy
Known For
Respiratory diseases
Top Products
NEXThaler, Trimbow, Curosurf, Holoclar

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 ...

A 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 ...