M14-430 - Upadacitinib CD Ph 3 Maintenance & Extension
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
IRAS ID
236159
Contact name
Richard (Ally) Speight
Contact email
Eudract number
2017-001225-41
Duration of Study in the UK
4 years, 9 months, 1 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 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 will include 738 patients at approximately 400 sites globally.
This study is for patients who participated in the M14-431 or M14-433 studies and will look at the long-term safety and effectiveness of Upadacitinib in patients with CD. All patients previously on the M14-431 or M14-433 studies who have responded at the end of the 12 week induction period or who have responded during the 12 week extended treatment period will have the option to participate in the M14-430 study.
The dose a patient receives is dependent on which preceding study and dose they received. If they met the response criteria and received Placebo or Upadacitinib medium dose during their first study they will continue to receive this dose. If they received high dose they will be re-allocated to medium dose, low dose or placebo equally for 52 weeks; the dose a patient will receive is not known by anyone for this part (blinded). Once the patient has completed this period they have the option to enter a new 240-week substudy and continue to receive the same medication as previously, this initially will be blinded and then become open label at a set point. There is an option for patients on placebo to move onto Upadacitinib low dose if they do not respond to treatment after 4 weeks.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0039
Date of REC Opinion
27 Mar 2018
REC opinion
Further Information Favourable Opinion