Admilparant for Pulmonary Fibrosis

Not yet recruiting at 275 trial locations
BC
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Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of the medication Admilparant for individuals with specific lung diseases. It targets those who participated in earlier studies for idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). The trial excludes individuals who experienced major issues during previous treatments or have conditions like heart failure at rest. Participants who completed a past study with Admilparant for these lung conditions without severe problems may be suitable candidates. As a Phase 3 trial, this study serves as the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Admilparant is likely to be safe for humans?

A previous study found the 60-mg dose of admilparant to be safe and well-tolerated by patients. This research supports further testing of the treatment in upcoming trials. Patients who took admilparant experienced less decline in lung function compared to those who did not. Over 26 weeks, patients treated with admilparant showed slower disease progression in both IPF (idiopathic pulmonary fibrosis) and PPF (progressive pulmonary fibrosis). Overall, the studies suggest that admilparant is generally safe for people, with no major side effects reported.12345

Why do researchers think this study treatment might be promising?

Admilparant is unique because it targets pulmonary fibrosis differently than current treatments. While most existing therapies focus on slowing disease progression by reducing inflammation, Admilparant aims to directly halt or reverse the fibrotic process itself. This novel approach could potentially improve lung function and quality of life more effectively than current standards like pirfenidone or nintedanib, which primarily aim to manage symptoms. Researchers are excited because Admilparant's mechanism offers hope for more robust outcomes for patients facing this challenging condition.

What evidence suggests that Admilparant might be an effective treatment for pulmonary fibrosis?

Studies have shown that Admilparant, a treatment for pulmonary fibrosis, can slow the disease's progression. Specifically, patients taking a 60-mg dose experienced a 69% slower decline in lung function over 26 weeks compared to those on a placebo. This drug blocks a receptor involved in lung scarring. Previous studies found Admilparant to be safe and well-tolerated by patients. These promising results support further investigation into its long-term benefits. Participants in this trial will receive Admilparant to evaluate its effectiveness and safety in treating pulmonary fibrosis.12467

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with pulmonary fibrosis who finished previous related studies and took the study drug until the end. You can't join if you have severe heart or lung issues, needed to stop the drug before, had a lung transplant or reduction surgery, or now need more intense treatment for certain high blood pressure in the lungs.

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

I have PAH and now need more than one medication to manage it.
I stopped a previous study drug due to serious side effects and did not restart it.
I have had lung reduction surgery or a lung transplant.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Admilparant to evaluate long-term safety and tolerability

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Admilparant

Trial Overview

The study is testing long-term safety and tolerability of Admilparant (BMS-986278) in people with pulmonary fibrosis. Only those who completed earlier trials with this medication can participate. The focus is on monitoring side effects over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BMS-986278 ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39393084/

Efficacy and Safety of Admilparant, an LPA1 Antagonist, in ...

60-mg admilparant slowed lung function decline and was safe and well tolerated, supporting further evaluation in phase 3 trials.

Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 ...

Treatment with 60-mg admilparant delayed time to disease progression over 26 weeks compared with placebo in both cohorts of patients.

Admilparant phase 2 results raise hopes for combination ...

A recent phase 2 trial of admilparant, a lysophosphatidic acid receptor 1 (LPA 1 ) antagonist and second generation drug, has shown it may slow the rate of ...

Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 ...

Treatment with 60-mg admilparant delayed time to disease progression over 26 weeks compared with placebo in both cohorts of patients.

NCT06003426 | A Study to Evaluate the Efficacy, Safety ...

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

NCT07441408 | Long-term Extension Study to Evaluate ...

The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies ...

Efficacy and Safety of Admilparant, an LPA 1 Antagonist ...

Targeting Autotaxin and Lysophosphatidic Acid in Pulmonary Fibrosis: Admilparant's Positive Results Show Continued Promise. Comments, Post a ...