A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants with Lung Fibrosis

Phase 1

• Conditions: Pulmonary Fibrosis; MedDRA version: 21.0Level: PTClassification code 10037383Term: Pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003992-21-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

For the idiopathic pulmonary fibrosis (IPF) Cohort:
- Diagnosis of IPF within 7 years
- Female and males = 40 years of age

For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort:
- Evidence of progressive ILD within the 24 months before screening
- Female and male = 21 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion Criteria

_Women who are of childbearing potential
_Active Smokers
_Patients with current malignancy
_History of allergy to BMS-986278 or related compounds

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified