Not yet recruiting NCT07441408

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

Phase III Interventional Pulmonary Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BMS-986278.
Who it may be relevant to: Registry conditions: Pulmonary Fibrosis. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +22
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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)).

Interventions

Drug BMS-986278
Specified dose on specified days

Primary outcome measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to Week 100]
Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to Week 100]
Number of Participants With AEs leading to Discontinuation [Time frame: Up to Week 100]
Number of Participants With AEs leading to Deaths [Time frame: Up to Week 100]
Number of Participants With Clinically Significant Laboraty Abnormalities [Time frame: Up to Week 100]
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities [Time frame: Up to Week 100]
Number of Participants With Clinically Significant Vital Sign Abnormalities [Time frame: Up to Week 100]

Eligibility criteria

Inclusion criteria

\- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).

Exclusion criteria

Clinically significant AE that resulted in discontinuation or interruption of IMP (Investigational Medicinal Product) in IM027068 or IM0271015 without reinitiation of IMP.
Exhibit symptoms of heart failure at rest.
History of lung reduction surgery or lung transplant. Note: Being on the transplantation list is allowed.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment