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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02489227 | Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis | PHASE3 | COMPLETED | 545 | — | — | Aug 1, 2015 | Mar 1, 2017 | Apr 8, 2020 | 99 | United States, Bulgaria +14 |
The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.
| Arm | Type | Description |
|---|---|---|
| Humira (adalimumab) | ACTIVE_COMPARATOR | Adalimumab (Humira) 40mg 2 doses at week 0/Day 0, then 1 dose every 2 weeks starting at Week 1 until Week 15. At Week 16 subjects initially randomized to adalimumab will be assigned (1:1) to CHS-1420 or continue adalimumab treatment, 1 dose every 2 weeks for weeks 17-23. The assignments for treatment sequences (Treatment Period 1 and Treatment Period 2) were made randomly at the beginning of Treatment Period 1. At week 24 subjects will switch to CHS-1420 open label until study end. |
| CHS-1420 | EXPERIMENTAL | CHS-1420 40mg 2 doses at Week 0/Day 0 then 1 dose every 2 weeks starting at Week 1 for 23 weeks. At Week 24 subjects will continue on to CHS-1420 open label until study end. |
| Name | Type | Description |
|---|---|---|
| CHS-1420 | DRUG | - |
| Adalimumab | DRUG | - |
Inclusion Criteria: * Male or female adults * PsO diagnosis for 6 months * Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0-5), * Body Surface Area (BSA) involved with PsO greater than or equal to 1...