Conditions: Psoriasis
Keywords: OPT Retreatment OPT chronic moderate severe treatment safety treatment withdrawal retreatment retreatment withdrawal CP-690,550 Psoriasis Vulgaris Plaque Psoriasis tofacitinib Xeljanz nail psoriasis Jak-inhibitor oral treatment Pruritus Itch DLQI rebound intermittent retreat
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 666
Healthy volunteers: no

Brief summary:
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Detailed description:

Arms:
arm 1: Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks arm 2: Continuous active treatment (CP-690,550) for 56 weeks arm 3: Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks arm 4: Continuous active treatment (CP-690,550) for 56 weeks

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550
Intervention descriptions: intervention 1: 10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design intervention 2: 10 mg oral BID intervention 3: 5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design intervention 4: 5 mg oral BID

Protocol document: