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Studies

Interventional Active not recruiting Phase 3

NCT06025578 on ClinicalTrials.gov

A Study 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

  • Sponsor: Bristol-Myers Squibb (United Kingdom)
  • Enrollment: 1057 (Estimated)
  • Study start: 2023-10-25 (Actual)
  • Primary completion: 2027-12-27 (Estimated)
  • Study completion: 2027-12-27 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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

Conditions

  • Progressive Pulmonary Fibrosis

Intervention / Treatment

  • Drug: BMS-986278
  • Drug: BMS-986278 Placebo

Primary Outcome Measures

  • Number of participants that experience spontaneous syncopal events (At approximately 4 weeks)
    Cohort 1
  • Absolute change from baseline in forced vital capacity (FVC) measured in mL (At Week 52)
    Cohort 2

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • Local Institution - 0046, Birmingham, United States
  • Local Institution - 0314, Phoenix, United States
  • Local Institution - 0336, La Jolla, United States
  • Local Institution - 0212, Los Angeles, United States
  • Local Institution - 0019, Los Angeles, United States
  • Local Institution - 0535, Newport Beach, United States
  • Local Institution - 0366, Orange, United States
  • Local Institution - 0341, Sacramento, United States
  • Local Institution - 0015, San Francisco, United States
  • Local Institution - 0352, Stanford, United States
  • Local Institution - 0321, Aurora, United States
  • Local Institution - 0376, Denver, United States
  • Local Institution - 0211, New Haven, United States
  • Local Institution - 0418, Stamford, United States
  • Local Institution - 0067, Newark, United States
  • Local Institution - 0354, Washington D.C., United States
  • Local Institution - 0195, Brandon, United States
  • Local Institution - 0380, Celebration, United States
  • Local Institution - 0013, Clearwater, United States
  • Local Institution - 0396, DeBary, United States
  • Local Institution - 0036, Gainesville, United States
  • Local Institution - 0193, Gainesville, United States
  • Local Institution - 0073, Loxahatchee Groves, United States
  • Local Institution - 0220, Ocala, United States
  • Local Institution - 0452, Pensacola, United States
  • Local Institution - 0389, St. Petersburg, United States
  • Local Institution - 0316, Tampa, United States
  • Local Institution - 0070, Atlanta, United States
  • Local Institution - 0368, Dublin, United States
  • Local Institution - 0435, Chicago, United States
  • Local Institution - 0023, Chicago, United States
  • Local Institution - 0040, Evanston, United States
  • Local Institution - 0082, Maywood, United States
  • Local Institution - 0080, Iowa City, United States
  • Local Institution - 0049, Kansas City, United States
  • Local Institution - 0045, Louisville, United States
  • Local Institution - 0361, Louisville, United States
  • Local Institution - 0305, Baltimore, United States
  • Local Institution - 0033, Towson, United States
  • Local Institution - 0404, Boston, United States
  • Local Institution - 0079, Springfield, United States
  • Local Institution - 0207, Ann Arbor, United States
  • Local Institution - 0031, Detroit, United States
  • Local Institution - 0050, Grand Rapids, United States
  • Local Institution - 0509, Royal Oak, United States
  • Local Institution - 0384, Minneapolis, United States
  • Local Institution - 0004, Chesterfield, United States
  • Local Institution - 0223, St Louis, United States
  • Local Institution - 0525, Reno, United States
  • Local Institution - 0068, Mount Kisco, United States

And 409 other sites.

Study Officials

  • Bristol-Myers Squibb (Study Director) — Bristol-Myers Squibb