BMS-986165 with background treatment in Lupus Nephritis

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis

• IRAS ID

  260867

• Contact name

  Benjamin Parker

• Contact email

  ben.parker@mft.nhs.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2018-004142-42

• Clinicaltrials.gov Identifier

  134 253, IND

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Summary of Research
  Systemic lupus erythematosus (SLE) is a long-term condition causing inflammation to the joints, skin and other organs. There is no cure. Lupus nephritis (LN) is one of the most serious manifestations of SLE. Approximately 38% of patients develop LN during their SLE diagnosis and 10 to 20% of them may progress to end-stage renal disease. LN confers an almost 3-fold higher risk of death than SLE without LN. The current standard of care treatments result in little more than half the patients showing some improvement in certain markers of disease activity. Long-term maintenance therapies are known to have potential toxic side effects and disease relapse is common. There remains an unmet need for well tolerated orally administered therapies that effectively modify the disease course and control symptoms. BMS-986165 blocks the action of proteins that are involved with inflammation and has shown to be effective in clinical study participants with psoriasis and in rodent models of SLE and LN.

  The purpose of this clinical study is to evaluate how safe and effective BMS-986165 is compared to placebo in participants with LN.

  The study is conducted in two parts. In Part A, participants will receive mycophenolate mofetil (MMF – a standard medicine for patients with lupus nephritis) for 12 weeks. Participants with an inadequate response to MMF will be asked to continue into Part B of the study. They will be randomised to receive one of two doses of BMS-986165 or placebo twice a day.

  Approximately 78 participants, aged 18 to 75, with LN will be enrolled globally. Participants will visit the hospital up to 20 times and will be in the study for about 73 weeks. Throughout the study, participants will be required to complete certain procedures, such as blood tests, biopsies, imaging and questionnaires.

  Summary of Results
  No plain language summary (PLS) will be available. Technical results of the study will be posted on clinicaltrials.gov and EudraCT

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  19/SW/0093

• Date of REC Opinion

  17 Jun 2019

• REC opinion

  Further Information Favourable Opinion