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NCT Number: NCT07441408

Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis

The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0003, Mar del Plata, B, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015.

Exclusion criteria

  • Any disease/condition that, in the investigator's judgment, may pose an unacceptable safety risk for study participation.
  • Any AE that resulted in permanent discontinuation of IMP in IM027068 or IM0271015.
  • Exhibit symptoms of heart failure at rest.
  • History of lung reduction surgery or lung transplant.
  • Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single-drug therapy that now requires multi-drug therapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Other names: Admilparant

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 100

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to Week 100

  3. Number of Participants With AEs leading to Discontinuation

    Time frame: Up to Week 100

  4. Number of Participants With AEs leading to Deaths

    Time frame: Up to Week 100

  5. Number of Participants With Clinically Significant Laboraty Abnormalities

    Time frame: Up to Week 100

  6. Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities

    Time frame: Up to Week 100

  7. Number of Participants With Clinically Significant Vital Sign Abnormalities

    Time frame: Up to Week 100

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 2, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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