Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03881059 | Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) | PHASE2 | COMPLETED | 203 | — | — | Apr 1, 2019 | Jan 27, 2021 | Feb 15, 2022 | 94 | United States, Czechia +7 |
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...