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

NCT07441408

Not Yet RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Pulmonary Fibrosis

Interventions: BMS-986278

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China

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 overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (275)
  • Birmingham, Alabama, United States
  • Ocala, Florida, United States
  • Philadelphia, Pennsylvania, United States
  • Florida, Vicente López, Buenos Aires, Argentina
  • Mar del Plata, Buenos Aires, Argentina
  • Quilmes, Buenos Aires, Argentina
  • San Juan Bautista, Buenos Aires, Argentina
  • Mar del Plata, B, Argentina
  • Córdoba, Córdoba Province, Argentina
  • CABA, Distrito Federal, Argentina
  • Godoy Cruz, Mendoza Province, Argentina
  • Mendoza, M, Argentina
  • Rosario, S, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Mendoza, Argentina
  • Santa Fe, Argentina
  • Camperdown, New South Wales, Australia
  • Chermside, Queensland, Australia
  • Greenslopes, Queensland, Australia
  • South Brisbane, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Frankston, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Nedlands, Western Australia, Australia
  • Melbourne, Australia
  • Wentworthville, Australia
  • Yvoir, Namur, Belgium
  • + 245 more on CT.gov