IM011-126: PK, Efficacy and Safety of BMS-986165 in Adolescent Moderate to Severe Plaque Psoriasis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BMS-986165 in Adolescent Subjects with Moderate to Severe Plaque Psoriasis
IRAS ID
1003533
Contact name
Head of Global Submission Management - Clinical Trials
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-004879-39
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 trial in adolescent patients with moderate to severe Plaque Psoriasis. The study will use 1 drug called BMS-986165 and will investigate if it is an effective treatment for 12 to <18 year old patients and assess safety. The study has 2 parts; Part A will evaluate how the body processes the drug after ingestion to allow the 2 best doses, based on the patient’s body weight to be confirmed. Part B will assess the safety and how well the drug works at those 2 doses. The study has 3 periods Screening, Treatment and safety follow-up. Part A will enrol first. Part B will enrol after data from Part A is assessed and the doses determined. Part A patients will receive either 4mg or 6mg of BMS-986165 once daily based on their weight for 2 weeks. After week 2 patients can decide to continue on the trial drug for up to 52 weeks. Part B patients will be randomly assigned to Arm 1, 2 or 3. For weeks 0-16, Arm 1 patients will receive standard dose of BMS-986165 per weight, Arm 2 will receive half-standard dose per weight, and Arm 3 will receive a placebo tablet once daily. After week 16; Arm 1 will continue on standard dose, Arm 2 patients with a disease improvement of more than 50% will stay on half-standard dose and patients with less than 50% improvement will move to standard dose, Arm 3 patients will be randomly assigned to receive either standard or half-standard dose. At week 32 those Arm 3 patients who were on half-standard dose who have a less that 50% improvement to their psoriasis will be changed to standard dose for the remaining treatment period. Part A patients will have up to 19 treatment visits and Part B patients will have up to 15 visits. Patients will be treated for 52 weeks unless: their disease progresses, they experience unacceptable side effects, they choose to withdraw, or the study is stopped. Patients will attend 2 follow-up visits at the trial centre on week 52 and 60. The study is funded by Bristol Myers Squibb.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0144
Date of REC Opinion
13 Apr 2021
REC opinion
Further Information Favourable Opinion