MLN0002SC-3027 Vedolizumab SC in Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

• IRAS ID

  193303

• Contact name

  Charles Murray

• Contact email

  charlesmurray1@nhs.net

• Sponsor organisation

  Takeda Development Centre Europe, Ltd

• Eudract number

  2015-000480-14

• Clinicaltrials.gov Identifier

  NCT02611830

• Duration of Study in the UK

  2 years, 4 months, 13 days

• Research summary

  The main purpose of this research study is to investigate the effectiveness and safety of vedolizumab subcutaneous (SC) injection compared to placebo (dummy drug) in patients with moderately to severely active Ulcerative Colitis (UC) after an initial treatment period with vedolizumab intravenous (IV) infusion. Vedolizumab IV has been approved by regulatory authorities to be sold and used in medical practice in several regions, including the European Union (EU) for the treatment of adults with moderately to severely active UC or Crohn’s Disease (CD) who have failed other conventional treatment

  A pre-filled syringe of vedolizumab subcutaneous (SC) is being developed and tested in this study to allow self-dosing by participants or their caregivers outside the clinic setting.
  The use of vedolizumab IV and SC in this study is investigational.

  This study will look at the effect vedolizumab SC has on UC by examining the gut in multiple ways - using clinical evaluations, flexible sigmoidoscopy (an examination that views the inside of the colon) and looking at the cells of intestine (histology). This study will also use questionnaires to examine the impact UC may have on the participant's quality of life.

  The study includes a 3-week Screening Period, a 6-week open-label vedolizumab IV Enrolment Period, a 46-week randomised Maintenance Period with vedolizumab SC / vedolizumab IV / placebo treatment, and an 18-week Follow-up Period after the last dose of study drug.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  16/LO/0089

• Date of REC Opinion

  7 Mar 2016

• REC opinion

  Further Information Favourable Opinion