Phase 2 Interstitial Lung Disease Trial, Recruiting NCT07516951 Sponsor: Chiesi Farmaceutici S.p.A. Condition: Interstitial Lung Disease
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Phase 2 Interstitial Lung Disease Trial, Recruiting

NCT07516951
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent before any study procedures begin.
  • Men or women of any race or ethnicity who are aged 40 or older and are expected to live at least one more year, in the opinion of the study doctor.
  • People who weigh at least 45 kg (approximately 99 pounds).
  • People who have been diagnosed with a lung condition called IPF (idiopathic pulmonary fibrosis) according to recognised international guidelines, with that diagnosis made no more than 8 years before joining the study, confirmed by a recent CT scan of the lungs taken within the last 6 months.
  • People whose lungs are functioning at or above certain minimum levels on breathing tests at the time of screening (confirm specific thresholds with trial site).
  • People whose lungs are able to transfer a sufficient amount of oxygen into the blood, as measured by a specific breathing test, at or above a minimum level at screening (confirm with trial site).
  • People whose blood oxygen level while at rest is above 90%, measured by a small device clipped to the finger, while using no more than a low flow of supplemental oxygen through a nasal tube (confirm with trial site).

Who may not be able to join:

  • People who have a documented diagnosis of coeliac disease.
  • People who have had a lower respiratory tract infection (such as pneumonia or bronchitis) in the 4 weeks before screening, or who have had a recent sudden worsening of their IPF symptoms typically lasting less than one month.
  • People who have been diagnosed with lung cancer, either currently or in the past.
  • People whose lung CT scan shows a significant amount of a condition called emphysema (damage to air sacs in the lungs), where emphysema covers 20% or more of the lungs, or where emphysema appears more widespread than the scarring from IPF.
  • People whose IPF is so advanced that a lung transplant is expected to be needed within 6 months of screening.
  • People who have other serious and uncontrolled medical conditions — including other lung diseases, heart conditions, liver, kidney, digestive, hormonal, nerve, or mental health conditions — or active or untreated tuberculosis, that in the study doctor's opinion could affect participation.
  • People who have any other lung condition (apart from IPF) that the study doctor believes may affect breathing test results.
  • People who are currently taking, or have taken within the past 48 weeks, certain medicines that suppress or modify the immune system, or who have been taking steroid tablets (such as prednisone) at doses above 10 mg per day for more than 10 days.
  • People who are known to be intolerant or allergic to any ingredient in the study treatment or other substances used in the study.
  • People who have had a serious allergic reaction to certain types of antibody-based medicines (human, humanised, chimeric, or murine monoclonal antibodies) in the past.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Vincent COTTIN, Louis Pradel Hospital - Lyon, FRANCE

Phone: + 39 0521 2791

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Chiesi Farmaceutici S.p.A.
Registry
ClinicalTrials.gov
Start date
8 July 2026
Est. completion
12 February 2028

Where this trial is recruiting

North Macedonia

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov