About the study
Disease target: Progressive Pulmonary Fibrosis
Recruitment target: 17
Duration: Minimum of 52 weeks up to 156 weeks
Study Locations
NSW
- Westmead Hospital
- Royal Prince Alfred Hospital
QLD
- Gallipoli Medical Health
- Mater Misericordiae Limited
VIC
- Box Hill Hospital
WA
- Institute for Respiratory Health
What is involved?
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Primary Outcome Measure in Cohort 2
Change in lung function (measured in absolute forced vital capacity (FVC)) from baseline at week 52.
Key Secondary Outcome Measures in Cohort 2
Disease progression measured by the time to first disease progression event up to approximately 3 years.
Change from baseline score of patient questionnaire, Living with Pulmonary Fibrosis (patient reported outcomes) (at week 52 and up to approximately 3 years).
Change from baseline in walking distance measured in 6-minute walk test (6MWT) (At week 52).
Investigational medicinal product, comparator and randomization
Active / oral; Matching placebo / oral; 1:1:1
Can I participate?
Inclusion Criteria
- ≥ 21 years of age;
- A clinical diagnosis of Interstitial Lung Disease (ILD) and fulfilling one of the following criteria:
o Centrally read HRCT that has ≥ 10% parenchymal fibrosis within the whole lung at screening or;
o features consistent with progressive ILD within 24 months prior to screening
- Immunosuppressive therapies are permitted provided that the participant is on a stable dose for at least 90 days prior to screening.
Exclusion Criteria
- Idiopathic Pulmonary Fibrosis along with usual interstitial pneumonia verification during screening.
- Acute exacerbation of pulmonary fibrosis within 4 weeks prior to or during screening.
- History of lung reduction surgery or lung transplant (being on transplantation list is allowed).
- History of stroke or transient ischemic attack within 3 months prior to screening.
- Participants who exhibit symptoms of heart failure at rest.