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Clinical Trials List

Protocol NumberIM027-040
NCT Number(ClinicalTrials.gov Identfier)NCT04308681

2021-05-01 - 2023-10-30

Phase II

Recruiting3

ICD-10J84.10

Pulmonary fibrosis, unspecified

ICD-10J84.112

Idiopathic pulmonary fibrosis

ICD-10J84.17

Other interstitial pulmonary diseases with fibrosis in diseases classified elsewhere

ICD-10J84.89

Other specified interstitial pulmonary diseases

ICD-9515

Postinflammatory pulmonary fibrosis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/11/08

Investigators and Locations

Principal Investigator HAO-CHIEN WANG Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsin-Kuo Ko Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Fibrosis

Objectives

Primary Objective: • To evaluate the rate of change from baseline to Week 26 in percent predicted forced vital capacity (ppFVC) in participants with idiopathic pulmonary fibrosis (IPF) randomized to receive 30 mg or 60 mg BMS-986278 twice daily (BID) compared with those randomized to receive placebo. Secondary Objectives: • To assess the safety and tolerability of BMS-986278 treatment for up to 26 weeks by comparing outcomes observed in participants with IPF and participants with progressive fibrotic interstitial lung diseases (PF-ILD) who are randomized to receive BMS-986278 30 mg or 60 mg BID versus placebo. Analyses will be performed separately for the IPF and PF-ILD cohorts. • To evaluate the rate of change from baseline to Week 26 in ppFVC in participants with PF-ILD randomized to receive 30 mg or 60 mg BMS-986278 BID compared with those receiving placebo. • To evaluate the treatment effect of BMS-986278 through Week 26 based on clinical assessments of pulmonary fibrosis in participants with IPF and PF-ILD randomized to receive 30 mg or 60 mg BMS-986278 BID versus placebo. Analyses will be performed separately for the IPF and PF-ILD cohorts. • To characterize the pharmacokinetics (PK) of BMS-986278 in participants with IPF and PF-ILD.

Test Drug

BMS-986278

Active Ingredient

BMS-986278
BMS-986278

Dosage Form

Tablet

Dosage

10 mg
30 mg

Endpoints

Rate of change (%) in percent predicted forced vital capacity (ppFVC) from baseline to Week 26 in participants with idiopathic pulmonary fibrosis (IPF).

Inclution Criteria

Inclusion Criteria:

For the idiopathic pulmonary fibrosis (IPF) Cohort

Diagnosis of IPF within 7 years of screening
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.

Exclusion Criteria

Exclusion Criteria:

Women of childbearing potential (WOCBP)
Active Smokers
Current malignancy or previous malignancy up to 5 years prior to screening
History of allergy to BMS-986278 or related compounds
Other protocol-defined inclusion/exclusion criteria apply

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    360 participants

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