M14-433 - Upadacitinib CD Ph 3 Conventional Therapy IR
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 Conventional Therapies but Have Not Failed Biologic Therapy.
IRAS ID
235048
Contact name
Richard (Ally) Speight
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2017-001240-35
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
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 2 stages and in total will include 300 patients at approximately 400 sites globally.
The study is looking at how effective and safe Upadacitinib is compared to placebo. Each patient will undergo a screening process of between 7 and 35 days after which they will follow a 12 week treatment phase, with 5 clinic visits, during which the patient is randomly assigned to one of 2 treatment courses. This treatment assignment and dose a patient receives is not known (blinded) from everyone involved throughout the study, even if the patient changes treatment as outlined below. Patients will be randomly assigned (2:1) to either Upadacitinib high dose, 200 patients, or Placebo, 100 patients, in Part 1. Once a patient completes 12 weeks if they have responded to treatment they will continue into the M14-430 study, if they have not responded then they will be given the option to enter Part 2 in which they will be re-allocated to Upadacitinib at one of two doses, high or medium depending on the initial dose they received, for 12 weeks with 3 clinic visits. If they respond after the further 12 weeks they will continue to the M14-430 study, if not then they will be discontinued and a 30 day follow up visit will be carried out.
Summary of Results
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.abbvieclinicaltrials.com%252Fstudy%252F%253Fid%253DM14-433%2FNBTI%2Fq5C4AQ%2FAQ%2F4edf8403-56ff-4ea5-9fef-0b3107dcfc60%2F2%2FLarZy_j7JL&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7Cf65534fa2ced4237249608dce86f8c0b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638640812990353171%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=DG8l5I%2FA42Qe4GkEsmXt8c%2B6y%2BA9s3B5MvrGyaIyQPQ%3D&reserved=0
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0038
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion