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A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-00547659 In Subjects With Crohn's Disease (OPERA)

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Trial Profile

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-00547659 In Subjects With Crohn's Disease (OPERA)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 31 Aug 2022

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At a glance

  • Drugs Ontamalimab (Primary)
  • Indications Crohn's disease
  • Focus Therapeutic Use
  • Acronyms OPERA
  • Sponsors Pfizer

Most Recent Events

  • 01 Jul 2022 Results reporting long-term safety and efficacy data for over 72 weeks published in the Inflammatory Bowel Diseases
  • 02 Mar 2020 Patients (n=440) were included from this and NCT01276509 studies in the PK and pharmacodynamic analyses based on the PK population of the trials published in the Journal of Clinical Pharmacology
  • 24 Oct 2018 Results from NCT01276509, NCT01620255 assessing efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of SHP647 in patients with ulcerative colitis or crohn's disease, presented at the 26th United European Gastroenterology Week.

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