Medivation - D5170C00002

• Research type

  Research Study

• Full title

  A Phase 2b Double-blind, Multi-dose, Placebo-controlled Study to\nEvaluate the Efficacy and Safety of MEDI2070 in Subjects with\nModerate to Severe Crohn’s Disease Who Have Failed or Are\nIntolerant to Anti-tumor Necrosis Factor-alpha Therapy

• IRAS ID

  192513

• Contact name

  Dr Syed Samiul Hoque

• Contact email

  sami.hoque@bartshealth.nhs.uk

• Sponsor organisation

  MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK

• Eudract number

  2015-000609-38

• Duration of Study in the UK

  1 years, 11 months, 10 days

• Research summary

  This is a 3-part Phase 2b study comprising a 16-week, double-blind,\nplacebo-controlled, induction period; a 12-week, double-blind, placebo-controlled,\nmaintenance period; and a 24-week, open-label period designed to evaluate the short-term efficacy and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active Crohn’s Disease who have failed or are intolerant to anti-Tumor Necrosis Factor (TNF) therapy as determined by the investigator.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  15/LO/2047

• Date of REC Opinion

  21 Apr 2016

• REC opinion

  Further Information Favourable Opinion