ALOFT-IPF

About the study

Disease target: Idiopathic Pulmonary Fibrosis (IPF)

Recruitment target: 47 participants

Duration: Minimum of 52 weeks up to 156 weeks

Study locations

NSW         

  • Westmead Hospital
  • Royal Prince Alfred Hospital

QLD

  • Gallipoli Medical Research
  • Prince Charles Hospital
  • Mater Misericordiae Limited

VIC

  • Peninsula Health 
  • Box Hill Hospital 

WA

  • Fiona Stanley Hospital  
  • Institute for Respiratory Health

SA      

  • Royal Adelaide Hospital

 

 

What is involved?

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic 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 randomisation

Active / oral; Matching placebo / oral; 1:1:1

Can I participate?

 

Inclusion Criteria
  •  ≥ 40 years of age
  • Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening
Exclusion Criteria
  • Interstitial Lung Disease (ILD) associated with known primary causes (e.g., hypersensitivity pneumonitis, autoimmune associated ILD, sarcoidosis, etc.).
  • 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).

For further information or if you would like to take part in this research study, please complete our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.

This study is sponsored by Bristol-Myers Squibb Company.