MLN0002SC-3031 Vedolizumab SC in Crohn's Disease
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
IRAS ID
196202
Contact name
Charles Murray
Contact email
Sponsor organisation
Takeda Development Centre Europe, Ltd
Eudract number
2015-000481-58
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 16 days
Research summary
The main purpose of this research study is to investigate the effectiveness and safety of subcutaneous (SC) injections of vedolizumab compared to SC injections of placebo (dummy drug) in participants with moderate to severely active Crohn's Disease (CD) after an initial treatment period with an intravenous (IV) infusion of vedolizumab. Vedolizumab IV has been approved and used in medical practice in several regions, including the European Union (EU) for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) or Crohn’s Disease (CD) who have failed other conventional treatment.
A prefilled syringe of vedolizumab for SC use is being developed and tested in this study to allow self-dosing by participants or their caregivers outside the hospital/clinic setting.
The use of IV and SC vedolizumab is investigational in this study.
This study will look at the effect vedolizumab SC has on CD using clinical evaluations. The participant will also be required to maintain a diary of how often they empty their bowels and if they notice any blood in their stool. Questionnaires will be used to examine the impact CD may have on the participant's quality of life.
The study includes a 3 week Screening Period, a 6 week open-label IV vedolizumab Enrolment Period, a 46 week double-blind (where neither the patient nor investigator know which treatment has been assigned) randomised Maintenance Period with SC vedolizumab / 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/0090
Date of REC Opinion
8 Mar 2016
REC opinion
Further Information Favourable Opinion