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Clinical Trial NCT07441408 for Pulmonary Fibrosis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis Phase 3 2,277
An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
- IM027-1016
- 2025-522373-10 (Other Identifier) (EU CTR)
- U1111-1322-7787 (Other Identifier) (WHO)
Idiopathic pulmonary fibrosis
Progressive pulmonary fibrosis
Long-term extension
IPF
PPF
IM027068
IM0271015
Follow up
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBMS-986278 Arm | BMS-986278 Specified dose on specified days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).
- 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.
Buenos Aires
B
Córdoba Province
Mendoza Province
M
S
New South Wales
Queensland
South Australia
Victoria
Western Australia
Namur
Vlaams-Brabant
Maule Region
Región de Valparaíso
ANT
DC
Santander Department
VAC
Capital Region
Region Midt
Region Syddanmark
Laensi-Suomen Laeaeni
Auvergne-Rhône-Alpes
Maine-et-Loire
Pays de la Loire Region
Provence-Alpes-Côte d'Azur Region
Dublin
Louth
Aguascalientes
Chihuahua
DIF
Edo de Mexico
Jalisco
Michoacán
Nuevo León
Oaxaca
Yucatán
South Holland
LIM
Porto District
Cantabria
C