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

NCT07441408 · tracked via the Priya Life Science Spain 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.

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Other trials for the same condition

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis Active, not recruiting

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 Spain