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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01782664 | A Dose Ranging Study to Evaluate the Safety and Efficacy of GSK2586184 in Patients With Chronic Plaque Psoriasis | PHASE2 | COMPLETED | 68 | — | — | Mar 1, 2013 | Mar 24, 2014 | Aug 3, 2017 | 15 | Germany, United Kingdom |
PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved \>= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.
| Arm | Type | Description |
|---|---|---|
| 100 mg GSK2586184 | EXPERIMENTAL | Subjects will be randomized to 100 mg GSK2586184 twice daily for up to 84 days |
| 200 mg GSK2586184 | EXPERIMENTAL | Subjects will be randomized to 200 mg GSK2586184 twice daily for up to 84 days |
| 400 mg GSK2586184 | EXPERIMENTAL | Subjects will be randomized to 400 mg GSK2586184 twice daily for up to 84 days |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized to receive Placebo twice daily for up to 84 days |
| 400 mg GSK2586184 (Cohort B) | EXPERIMENTAL | Subjects will take 400 mg GSK2586184 twice daily for up to 84 days |
| Name | Type | Description |
|---|---|---|
| 100 mg GSK2586184 | DRUG | 100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
| 200 mg GSK2586184 | DRUG | 200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
| 400 mg GSK2586184 | DRUG | 400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. |
| Placebo | DRUG | Placebo tablets to be taken twice daily with food for up to 84 days. |
Inclusion Criteria: * Otherwise healthy subjects with a diagnosis of moderate to severe plaque psoriasis defined by the following criteria: * Diagnosed for at least 12 months before the first dose of study medication * Psoriasis plaques cover \>=10% of body surface area. * PASI score of \>=12, and ...