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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02630901 | Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis | PHASE1 | COMPLETED | 48 | — | — | Mar 17, 2016 | Feb 28, 2018 | May 4, 2018 | 9 | United States |
| NCT02458677 | Single Ascending Dose Study of PRX003 in Healthy Subjects | PHASE1 | COMPLETED | 40 | — | — | May 1, 2015 | Feb 1, 2016 | Mar 16, 2016 | 1 | United States |
time of the maximum measured concentration (Tmax)
maximum concentration (Cmax)
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
elimination rate constant
terminal elimination half life (t½)
clearance (CL)
apparent volume of distribution (Vd)
| Arm | Type | Description |
|---|---|---|
| PRX003 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PRX003 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Male or female, 18 to 80 years of age (inclusive), body weight range of ≥ 45 kg (99 lbs) to ≤ 120 kg (264 lbs) and a body mass index (BMI) of 18 - 35 kg/m2 2. Provide written informed consent 3. PASI score of ≥12 4. Plaque psoriasis covering ≥10% of BSA 5. s-PGA score of 3 or...