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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Fibrosis

Treatments: Other: BMS-986278 Placebo; Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT04308681

IM027-040

2019-003992-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

Enrollment: 403 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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403 participants in 6 patient groups, including a placebo group

IPF Dose 1 + Post Treatment Follow-up or OTE

Experimental group

Description:

IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)

Treatment:

Drug: BMS-986278

IPF Dose 2 + Post Treatment Follow-up or OTE

Experimental group

Treatment:

Drug: BMS-986278

IPF Placebo + Post Treatment Follow-up or OTE

Placebo Comparator group

Treatment:

Other: BMS-986278 Placebo

PF-ILD Dose 1 + Post Treatment Follow-up or OTE

Experimental group

Description:

PF-ILD (Progressive Fibrotic Interstitial Lung Disease)

Treatment:

Drug: BMS-986278

PF-ILD Dose 2 + Post Treatment Follow-up or OTE

Experimental group

Treatment:

Drug: BMS-986278

PF-ILD Placebo + Post Treatment Follow-up or OTE

Placebo Comparator group

Treatment:

Other: BMS-986278 Placebo