Health TrialsbyHealthPanel

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

ConditionPulmonary Fibrosis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBristol-Myers Squibb

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986278

    Drug

    Specified dose on specified days

Treatment groups

2,380 Participants
are divided into 1 treatment group
Group A: BMS-986278 ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame
Up to Week 100
2

Number of Participants With Serious Adverse Events (SAEs)

Time frame
Up to Week 100
3

Number of Participants With AEs leading to Discontinuation

Time frame
Up to Week 100
4

Number of Participants With AEs leading to Deaths

Time frame
Up to Week 100

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: