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GSK2586184 · 1 trial · 1 indication
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 ...
GSK2586184 is an investigational small molecule being developed for psoriasis and systemic lupus erythematosus. It has been studied in clinical trials for these conditions, including a Phase 2 dose-ranging study in patients with chronic plaque psoriasis. The drug is not approved and remains in clinical development.
GSK2586184 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company has sponsored clinical trials of the drug in psoriasis and systemic lupus erythematosus.
GSK2586184 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study evaluated the drug in patients with chronic plaque psoriasis. The drug is investigational and has not received regulatory approval. No active trials are currently listed for GSK2586184.
GSK2586184 has been studied in three completed clinical trials. NCT01687309 was a Phase 1 study in healthy volunteers and patients with systemic lupus erythematosus. NCT01782664 was a Phase 2 dose-ranging study in psoriasis patients. NCT01953835 was a Phase 1 drug interaction study in systemic lupus erythematosus.
GSK2586184 is the code name for this investigational compound. No alternative brand names or other designations have been disclosed for the drug. It is identified solely by its GSK development code in clinical trial registries and scientific literature.