Conditions: Psoriasis
Keywords: PASI DLQI GSK2586184 plaque-type psoriasis PGA inflammatory gene transcription JAK-1 inhibitor serum neopterin skin biopsy ACR response criteria VAS itch score
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief summary:
A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis.

There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184.

In both Cohorts A and B, study medication will be administered orally (as tablets), twice daily, for up to 12 weeks.

Each subject will have 7 out-patient visits: Screening; Baseline \& Start of treatment; Week 2; Week 4; Week 8; Week 12; and Follow-up (Week 16)

Detailed description:

Arms:
arm 1: Subjects will be randomized to 100 mg GSK2586184 twice daily for up to 84 days arm 2: Subjects will be randomized to 200 mg GSK2586184 twice daily for up to 84 days arm 3: Subjects will be randomized to 400 mg GSK2586184 twice daily for up to 84 days arm 4: Subjects will be randomized to receive Placebo twice daily for up to 84 days arm 5: Subjects will take 400 mg GSK2586184 twice daily for up to 84 days

Interventions: intervention 1: 100 mg GSK2586184 intervention 2: 200 mg GSK2586184 intervention 3: 400 mg GSK2586184 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 2: 200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 3: 400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 4: Placebo tablets to be taken twice daily with food for up to 84 days.

Protocol document: