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Lung fibrosis drug study halted early

NCT ID NCT05497284

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested new single treatments for idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and makes breathing hard. It included 46 adults aged 40 and older with mild to moderate IPF. The main goal was to see if the treatments improved lung function, measured by how much air they could exhale. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

46 people

The number who actually took part.

Started

Nov 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants at least 40 years of age * IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines * FVC ≥45% predicted * DLCO, corrected for hemoglobin, ≥25% predicted (inclusive) * Unlikely to undergo lung transplantation during this trial in the opinion of the investigator * If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization Exclusion Criteria: * Airway obstruction (i.e. prebronchodilator FEV1/ FVC \< 0.7) or evidence of a bronchodilator response at screening * Emphysema \>20% on screening HRCT * Fibrosis \<10% on screening HRCT * Clinical diagnosis of any connective tissue disease * Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization Additional protocol-defined inclusion / exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Novartis Investigative Site

    CABA, Buenos Aires, C1056ABJ, Argentina

  • Novartis Investigative Site

    Ranelagh Partido de Berazate, Buenos Aires, 1884, Argentina

  • Novartis Investigative Site

    Paraná, 3100, Argentina

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    Chermside, Queensland, 4032, Australia

  • Novartis Investigative Site

    Spearwood, Western Australia, 6163, Australia

  • Novartis Investigative Site

    Prague, 140 59, Czechia

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Coswig, 01640, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Novartis Investigative Site

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • Novartis Investigative Site

    Bialystok, 15-044, Poland

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

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