Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986165 Dose A · 1 trial · 1 indication
A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
| Arm | Type | Description |
|---|---|---|
| Part A: Placebo | PLACEBO_COMPARATOR | - |
| Part A: BMS-986165 Dose A | EXPERIMENTAL | - |
| Part A: BMS-986165 Dose B | EXPERIMENTAL | - |
| Part B: Ustekinumab + BMS-986165 Placebo | EXPERIMENTAL | - |
| Part B: BMS-986165 Dose A + Ustekinumab Placebo | EXPERIMENTAL | - |
| Part B: BMS-986165 Dose B + Ustekinumab Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986165 Placebo | OTHER | Participants will receive BMS-986165 matching placebo QD |
| BMS-986165 Dose A | DRUG | Participants will receive BMS-986165 Dose A QD. |
| BMS-986165 Dose B | DRUG | Participants will receive BMS-986165 dose B QD. |
| Ustekinumab | DRUG | Participants will receive ustekinumab SQ injection QD. |
| Ustekinumab Placebo | OTHER | Participants will receive ustekinumab SQ matching placebo QD |
Inclusion Criteria: * Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening * Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumo...
BMS-986165 Dose A is an investigational small molecule being studied for the treatment of active psoriatic arthritis, a type of inflammatory arthritis that affects people with psoriasis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
BMS-986165 Dose A is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with active psoriatic arthritis.
BMS-986165 Dose A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being evaluated in a completed Phase 2 trial for active psoriatic arthritis.
BMS-986165 Dose A has one completed clinical trial, identified as NCT03881059, titled 'Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA).' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 203 participants across multiple countries.
BMS-986165 Dose A is a specific dose of the drug BMS-986165, which is being developed by Bristol-Myers Squibb. The trial NCT03881059 evaluates BMS-986165 at various doses, including Dose A, against placebo in patients with active psoriatic arthritis.