Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSF
Dates
study started
completion around

Description

Summary

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

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

Keywords

Progressive Pulmonary Fibrosis, BMS-986278, LPA1 antagonist, Pulmonary fibrosis, Interstitial lung disease, Rheumatoid Arthritis, Connective Tissue Disorders, Sarcoidosis, Scleroderma, Fibrosis, Antifibrotic therapy

Eligibility

You can join if…

Open to people ages 21 years and up

  • 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.
  • Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
  • Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
  • Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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.

You CAN'T join if...

  • Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
  • 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.
  • Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095-3075 United States
  • UC Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States
  • University of California UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • University of California, San Francisco Medical Center- Pulmonary Practice accepting new patients
    San Francisco California 94143-2202 United States
  • Local Institution - 0336 not yet accepting patients
    La Jolla California 92037-1027 United States
  • Local Institution - 0066 not yet accepting patients
    La Jolla California 92093 United States
  • University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic accepting new patients
    Los Angeles California 90033-5313 United States
  • Stanford Hospital and Clinics accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06025578
Phase
Phase 3 Fibrosis Research Study
Study Type
Interventional
Participants
Expecting 1092 study participants
Last Updated