Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With… (NCT07441408) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
United States, Argentina, Australia2,277 participantsStarted 2026-12-16
Plain-language summary
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)).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 100
2
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to Week 100
3
Number of Participants With AEs leading to Discontinuation
Timeframe: Up to Week 100
4
Number of Participants With AEs leading to Deaths
Timeframe: Up to Week 100
5
Number of Participants With Clinically Significant Laboraty Abnormalities
Timeframe: Up to Week 100
6
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Timeframe: Up to Week 100
7
Number of Participants With Clinically Significant Vital Sign Abnormalities
Timeframe: Up to Week 100
Trial details
NCT IDNCT07441408
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-11-22
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com