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ZAMPILIMAB

Clinical trials are investigating ZAMPILIMAB in people with idiopathic pulmonary fibrosis (IPF), a long-term lung disease that causes scarring. These studies aim to find a dose that is safe and effective, and to measure changes in lung function. The main target population is adults with IPF.

Table of contents

Trial overview

The available trial data show one authorised study of ZAMPILIMAB in people with idiopathic pulmonary fibrosis, also called IPF[1]. The study title says it is looking for an efficacious and safe dose of CHF10067, which is identified as zampilimab in the source data[1].

This is an interventional clinical trial, which means researchers give a study treatment and then measure the results[1]. The trial is authorised and plans to enrol 235 participants[1].

Condition studied and who can join

The trial is for participants with idiopathic pulmonary fibrosis[1]. IPF is a lung disease that causes scarring and can reduce breathing ability; the trial data do not provide more detail about symptoms or disease stage[1].

The source data do not list full entry rules such as age limits, test results, or previous treatments[1]. Based on the available information, the target population is people living with IPF[1].

Treatment and comparison

The study intervention includes ZAMPILIMAB given by intravenous infusion, which means it is delivered into a vein[1]. The trial data also mention 0.9% sodium chloride aqueous solution for IV infusion as the comparison treatment[1].

The brief summary says the study is evaluating two dose strengths of CHF10067 and comparing them with placebo in the entire study population[1]. In simple words, the trial is checking whether different doses work better than a non-active comparison treatment[1].

Study phase and design

This is a Phase 2 study[1]. Phase 2 trials usually focus on whether a treatment may help and continue to watch safety in a larger group than early studies, but the source data only confirm the phase and do not add more design details[1].

The study is listed as interventional and authorised, with an expected enrolment of 235 participants[1]. The available data do not describe randomisation, masking, or how many study groups there are[1].

What the trial measures

The primary outcome is measured at Week 24[1]. The main endpoint is the change from baseline in percent predicted forced vital capacity, or ppFVC, compared with placebo in the whole study population[1].

Forced vital capacity is a lung function test that shows how much air a person can breathe out after taking a deep breath[1]. ‘Percent predicted’ means the result is compared with what would be expected for someone of similar age, sex, height, and background[1].

Why this trial matters for patients

For people with IPF, lung function can slowly get worse over time, so studies that measure breathing tests are important[1]. This trial is designed to see whether ZAMPILIMAB can improve or preserve lung function better than placebo over 24 weeks[1].

Because only one trial is provided in the source data, the current picture is limited to this Phase 2 study in IPF[1]. The most important facts from the available record are the condition studied, the authorised status, the planned enrolment of 235 participants, and the focus on ppFVC at Week 24[1].

Trial IDPhaseCondition studiedStatusEnrollment
2024-514246-37-00Phase 2Idiopathic pulmonary fibrosis (IPF)Authorised235

FAQ

  • What condition is ZAMPILIMAB being studied for? ZAMPILIMAB is being studied for idiopathic pulmonary fibrosis, often called IPF. This is a disease that causes scarring in the lungs and can make breathing harder.
  • What is the main goal of the trial? The main goal is to find a dose of ZAMPILIMAB that is both effective and safe. The trial also looks at whether it can improve lung function compared with placebo.
  • Who can take part in the study? The study is for participants with idiopathic pulmonary fibrosis. The trial data do not give more details about age or other entry rules.
  • What phase is the ZAMPILIMAB trial? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue checking safety.
  • What outcome is the study measuring? The main outcome is the change in percent predicted forced vital capacity, or ppFVC, at Week 24. ppFVC is a lung test that shows how much air a person can breathe out.

Ongoing Clinical Trials on ZAMPILIMAB

  • A study to evaluate the safety and effectiveness of zampilimab in people with idiopathic pulmonary fibrosis

    Not yet recruiting

    2 1
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Italy +5

Glossary

  • Idiopathic pulmonary fibrosis (IPF): A long-term lung disease that causes scarring in the lungs. 'Idiopathic' means the exact cause is not known.
  • Phase 2: A study stage that looks at whether a treatment may work and continues to check safety in a group of participants.
  • Efficacy: How well a treatment works in a study.
  • Safety: How well a treatment is tolerated and whether it causes problems in the study.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine.
  • Interventional study: A clinical trial where researchers give a treatment and then measure the results.
  • Percent predicted forced vital capacity (ppFVC): A lung test result that compares how much air a person can blow out with what is expected for someone like them.
  • Baseline: The first measurement taken before treatment starts.
  • Week 24: The study time point 24 weeks after the start of the trial.
  • Enrolment: The number of people planned or included in the study.

References

  1. https://clinicaltrials.gov/study/2024-514246-37-00