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The trial is taking place at:
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Louisville Pulmonary Care | Louisville, KY

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A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 3

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: BMS-986278 Placebo
Drug: BMS-986278

Study type

Interventional

Funder types

Industry

Identifiers

NCT06003426
IM027-068

Details and patient eligibility

About

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

Enrollment

1,185 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Subjects with IPF aged ≥ 40 years at the time of signing the informed consent.
  • Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia.
  • 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.
  • Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
  • Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Exclusion Criteria

  • History of stroke or transient ischemic attack within 3 months prior to screening.
  • Participants who exhibit symptoms of heart failure at rest.
  • Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,185 participants in 3 patient groups, including a placebo group

BMS-986278 Dose 1
Experimental group
Treatment:
Drug: BMS-986278
BMS-986278 Dose 2
Experimental group
Treatment:
Drug: BMS-986278
BMS-986278 Placebo
Placebo Comparator group
Treatment:
Drug: BMS-986278 Placebo

Trial contacts and locations

495

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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