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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02714322 | MYL-1401A Efficacy and Safety Comparability Study to Humira® | PHASE3 | COMPLETED | 294 | — | — | Jun 1, 2015 | Mar 1, 2017 | Mar 11, 2022 | 33 | Bulgaria, Estonia +4 |
| Arm | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | EXPERIMENTAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | ACTIVE_COMPARATOR | Humira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Name | Type | Description |
|---|---|---|
| MYL-1401A (Adalimumab) | BIOLOGICAL | MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose |
| Humira® (Adalimumab) | BIOLOGICAL | Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose |
Inclusion Criteria: 1. Subject has signed the informed consent form 2. Subject is aged 18 to 75 years, inclusive, at time of Screening 3. Subject has had moderate-to-severe chronic plaque psoriasis for at least 6 months * Subject has involved BSA ≥10%, PASI ≥12, and sPGA ≥3 (moderate) at Screen...