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A PHASE 3, MULTI-SITE, RANDOMIZED, MIXED-BLIND, PARALLEL-GROUP TREATMENT WITHDRAWAL AND RE-TREATMENT STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

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Trial Profile

A PHASE 3, MULTI-SITE, RANDOMIZED, MIXED-BLIND, PARALLEL-GROUP TREATMENT WITHDRAWAL AND RE-TREATMENT STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms OPT Retreatment
  • Sponsors Pfizer

Most Recent Events

  • 12 Mar 2016 Pooled analysis (n=3431) of 5 trials [NCT00678210, NCT01276639, NCT01309737, NCT01241591, NCT01186744] were presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 04 Feb 2015 As per media release, the FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in October 2015 for the sNDA.
  • 04 Feb 2015 As per the media release, based on data from this and other 4 trials (OPT clinical programme), the US FDA has accepted for review the sNDA for tofacitinib 5 and 10mg twice daily for treating adult patients with moderate-to-severe chronic plaque psoriasis.

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