M14-234 Phase 2b/3 study in Mod/Severe Ulcerative Colitis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
IRAS ID
210329
Contact name
Varvara Kontomina
Contact email
Eudract number
2016-000641-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 26 days
Research summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and large intestine. Patients currently have treatment options for UC but they are not always effective. This study intends to see if a new drug (ABT-494) might help patients with moderate to severe UC.\n\nThe study has 3 parts. Substudies 1 and 2, followed by a maintenance period (substudy 3). The study will include 1055 patients at approximately 475 sites globally.\n\nSubstudy 1 is 8 weeks long and consists of two parts. Part one looks at how effective and safe ABT-494 is compared to placebo and will identify the dose of ABT-494 to use in Substudy 2. 250 eligible patients will be randomly assigned to one of five different treatments, four with ABT-494 and one with placebo; the dose a patient receives is not known by anyone (blinded). Once fully recruited, part two will involve 100 further patients being randomised to blinded ABT-494.\n\nSubstudy 2 is 8 weeks long and consists of two parts. In part one patients will be randomly assigned (2:1 ratio) to receive ABT-494 (the dose decided from substudy 1) or placebo and is blinded. After part one, a further 330 eligible patients will be given ABT-494 only at the same dose, so will know the drug they are on (open label) in part 2. \n\nSubstudy 3 is the 44 week maintenance portion for patients who complete Substudies 1 or 2 and responded to their treatment. They will continue to receive the same drug or be re-randomised to another dose or placebo, depending on what they received previously. Patients who complete 8 weeks induction and do not respond, lose their response during maintenance or complete this study will be able to join an extension study and receive ABT-494.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1675
Date of REC Opinion
7 Dec 2016
REC opinion
Further Information Favourable Opinion