M14-431 - Upadacitinib CD Ph 3 Biologics Inadequate Response
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Biologic Therapy
IRAS ID
228917
Contact name
Richard (Ally) Speight
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2017-001226-18
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Crohns Disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gastro-intestinal tract. Currently no known medical or surgical cure exists for CD. At present, treatment objectives for CD involve reducing the symptoms, to reduce the inflammation and improve quality of life. Upadacitinib (ABT-494) is a new drug being used in this study; it is being developed for adult patients with inflammatory diseases with the aim of controlling inflammation and reducing symptoms for those suffering from CD.
The study has 3 parts lasting up to 24 weeks and will include 855 patients at approximately 400 sites globally.
Part 1 is looking at how effective and safe Upadacitinib is compared to placebo. 495 eligible patients will be randomly assigned (2:1) to either Upadacitinib high dose, 330 patients, or Placebo, 165 patients, for 12 weeks; the dose a patient receives is not known by anyone (blinded). Once Part 1 is full, Part 2 will be opened for patients.
Part 2 is up to 12 weeks long with 360 patients being given Upadacitinib high dose open label.
When a patient completes 12 weeks of Part 1 or Part 2, if they have responded to treatment they will continue into the M14-430 study, if they have not responded they will enter Part 3 and be re-allocated, depending on their first treatment, to Upadacitinib at one of two doses for another 12 weeks. If they respond after 12 weeks they will continue to the M14-430 study, if not they will discontinue.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0037
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion