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

NCT07441408 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2026-12-16

Last updated

2026-08-14

Condition(s) studied

Pulmonary Fibrosis

Investigational drug(s) / intervention(s)

BMS-986278

BMS-986278: Specified dose on specified days

Study 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)).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (275)

Facility	City	Region
Local Institution - 0113	Birmingham	Alabama
Local Institution - 0111	Ocala	Florida
Local Institution - 0119	Philadelphia	Pennsylvania
Local Institution - 0013	Florida, Vicente López	Buenos Aires
Local Institution - 0014	Mar del Plata	Buenos Aires
Local Institution - 0007	Quilmes	Buenos Aires
Local Institution - 0009	San Juan Bautista	Buenos Aires
Local Institution - 0003	Mar del Plata	B
Local Institution - 0001	Córdoba	Córdoba Province
Local Institution - 0005	CABA	Distrito Federal
Local Institution - 0002	Godoy Cruz	Mendoza Province
Local Institution - 0011	Mendoza	M
Local Institution - 0015	Rosario	S
Local Institution - 0012	San Miguel de Tucumán	Tucumán Province
Local Institution - 0010	Buenos Aires	Argentina
Local Institution - 0004	Buenos Aires	Argentina
Local Institution - 0016	CABA	Argentina
Local Institution - 0006	Mendoza	Argentina
Local Institution - 0008	Santa Fe	Argentina
Local Institution - 0287	Camperdown	New South Wales
Local Institution - 0290	Chermside	Queensland
Local Institution - 0291	Greenslopes	Queensland
Local Institution - 0293	South Brisbane	Queensland
Local Institution - 0289	Adelaide	South Australia
Local Institution - 0288	Frankston	Victoria
Local Institution - 0285	Murdoch	Western Australia
Local Institution - 0292	Nedlands	Western Australia
Local Institution - 0286	Melbourne	Australia
Local Institution - 0284	Wentworthville	Australia
Local Institution - 0249	Yvoir	Namur
Local Institution - 0252	Leuven	Vlaams-Brabant
Local Institution - 0248	Brussels	Belgium
Local Institution - 0251	Kortrijk	Belgium
Local Institution - 0250	Liège	Belgium
Local Institution - 0086	Belo Horizonte	Minas Gerais
Local Institution - 0031	Belo Horizonte	Minas Gerais
Local Institution - 0194	Barra Mansa	Rio de Janeiro
Local Institution - 0027	Porto Alegre	Rio Grande do Sul
Local Institution - 0028	Porto Alegre	Rio Grande do Sul
Local Institution - 0032	Porto Alegre	Rio Grande do Sul

+ 235 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441408 on ClinicalTrials.gov ↗ ← All trials in the UK