Condition

Progressive Pulmonary Fibrosis

Purpose of the study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. NCT06025578 

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis.

Who is eligible to participate?

Inclusion Criteria

• Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
• If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
• If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.

Exclusion Criteria

• Idiopathic Pulmonary Fibrosis with usual interstitial pneumonia (UIP) verification at screening.
• History of stroke or transient ischemic attack within 3 months prior to screening.
• Use of corticosteroids equivalent to prednisone >15mg/day is not allowed within 4 weeks prior to screening and during the study.
• Participants who have a current malignancy; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of mallgnancy cannot be reasonable excluded following additonal clinical, laboratory, or other diagnostic evaluations. .

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane