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IM027-040 - BMS-986278 in patients with Pulmonary Fibrosis

  • Research type

    Research Study

  • Full title

    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

  • IRAS ID

    1003409

  • Contact name

    Philip Molyneaux

  • Contact email

    p.molyneaux@rbht.nhs.uk

  • Eudract number

    2019-003992-21

  • Research summary

    BMS-986278 is an investigational drug, which is not approved and not on the market. To\ndate, it has been studied in about 122 healthy participants.\nBMS-986278 is a type of drug known as a lysophosphatidic acid receptor 1 (LPA1)\nantagonist (like a blocker). Patients with IPF have increased levels of LPA in their lungs.\nBMS-986278 works by helping wound healing and tissue fibrosis.\nThis study is the first evaluation of BMS-986278 in participants with pulmonary fibrosis.\nThis study is designed to provide an initial evaluation of the efficacy of BMS-986278 in\nparticipants with IPF, further demonstrate the safety of BMS-986278, and provide\ninformation on pharmacokinetics (PK) of BMS-986278 in participants with IPF.\nIn addition, a secondary cohort consisting of PF-ILD participants will be enrolled in\norder to assess for safety, tolerability and efficacy of BMS-986278 in PF-ILD.\nThe trial is sponsored by Bristol Myers Squibb.\nPatients will receive either BMS-986278 (oral tablets) or matching placebo twice a day\n(morning and evening, about 12 hours apart) for 26 weeks (6 months). This is a double\nblind trial which means neither the patient nor the study doctor will not know what\ntreatment they are assigned to.\nEntry into this study is voluntary and your patients may withdraw at any time, after which\nhe/she will continue to receive the most appropriate standard treatment. There may be no\ndirect benefit to your patient, however, your patient will be provided with more frequent\nmedical examinations and tests than would be routinely done as standard of care.\nThe study is sponsored by Bristol Myers Squibb.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    20/YH/0263

  • Date of REC Opinion

    21 Oct 2020

  • REC opinion

    Favourable Opinion