A Phase 3 study of BMS-986165 in participants with plaque psoriasis

• Research type

  Research Study

• Full title

  A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study with Randomized Withdrawal and Retreatment to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

• IRAS ID

  250624

• Contact name

  Philip Laws

• Contact email

  philip.laws2@nhs.net

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2018-001925-24

• Clinicaltrials.gov Identifier

  NCT03611751

• Clinicaltrials.gov Identifier

  131,993, IND

• Duration of Study in the UK

  1 years, 6 months, 5 days

• Research summary

  Research Summary
  This research study is testing an experimental medicine called BMS-986165, to see if it is effective and safe for the treatment of moderate-to-severe plaque psoriasis. Psoriasis is a chronic inflammatory skin disorder, characterised primarily by scaly plaques which affect up to 3% of the general population. Despite the treatments currently available, there remains a need for more effective oral treatments that could improve efficacy and adherence to treatment for patients. The rationale for completing this study is due to results of a recently completed study which showed BMS-986165 to be effective in comparison to placebo. This phase 3 study is designed to confirm the efficacy and safety of BMS-986165.

  The research will be run in NHS and non-NHS sites in the UK and at sites globally. Approximately 1,000 participants (men and women aged 18 and over) with moderate-to-severe plaque psoriasis will take part. Participants will be treated with either BMS-986165 (6 mg once daily), placebo or apremilast (30 mg twice daily) (a medication already used for the treatment of psoriasis). BMS-986165 is an oral medication which may help control the immune system (which is responsible for the signs and symptoms of psoriasis), by helping to control the molecules in the body responsible for inflammation of the skin.

  Participation in the study will last 60 weeks and will comprise of a screening visit (up to 4 weeks), treatment visit (24 weeks), re-assignment of treatment (28 weeks) (where participants may be given a different treatment to what they were initially assigned (either placebo or BMS-986165), depending on their response to the initial treatment) and a follow up visit (4 weeks). During these periods participants will be asked to undergo procedures including eligibility assessments, safety measurements and laboratory tests. In addition, participants will be asked to complete questionnaires and a study diary daily.

  Summary of Results
  Not available yet.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  18/WM/0347

• Date of REC Opinion

  7 Jan 2019

• REC opinion

  Further Information Favourable Opinion