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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02173301 | A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis | PHASE2 | COMPLETED | 200 | — | — | Jun 1, 2014 | Aug 1, 2015 | Apr 12, 2022 | 31 | United States |
The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
| Arm | Type | Description |
|---|---|---|
| XP23829 400 mg QD (once daily) | EXPERIMENTAL | After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period |
| XP23829 800 mg QD | EXPERIMENTAL | After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period |
| XP23829 400 mg BID (twice daily) | EXPERIMENTAL | After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period |
| Placebo | PLACEBO_COMPARATOR | After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks |
| Name | Type | Description |
|---|---|---|
| XP23829 400 mg QD | DRUG | active dose 1 |
| XP 23829 800 mg QD | DRUG | active dose 2 |
| XP23829 400 mg BID | DRUG | active dose 3 |
| Placebo | DRUG | control |
Inclusion Criteria: 1. Male and female subjects, age ≥ 18. 2. Stable, moderate-to-severe plaque-type psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator). 3. Severit...