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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01614756 | A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis | PHASE1 | COMPLETED | 93 | — | — | Jul 1, 2012 | Apr 1, 2015 | Aug 19, 2015 | 4 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously |
| Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo | EXPERIMENTAL | Part 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously |
| Dose Escalation- BMS-981164 or Placebo (dose group 1) | EXPERIMENTAL | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 2) | EXPERIMENTAL | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 3) | EXPERIMENTAL | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
| Dose Escalation- BMS-981164 or Placebo (dose group 4) | EXPERIMENTAL | Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and \>1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose |
| Name | Type | Description |
|---|---|---|
| BMS-981164 | BIOLOGICAL | - |
| Placebo matching with BMS-981164 | BIOLOGICAL | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Part 1: Healthy subjects * Part 2: Adult subjects with: 1. Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or g...