M14-675 Phase 3 study in Mod/Severe Ulcerative Colitis

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

• IRAS ID

  257506

• Contact name

  Kate Molony

• Contact email

  kate.molony@abbvie.com

• Eudract number

  2016-000642-62

• Clinicaltrials.gov Identifier

  NCT03653026

• Duration of Study in the UK

  2 years, 5 months, 1 days

• Research summary

  Summary of Research
  Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). Despite the availability of various UC therapies, such as aminosalicylates, corticosteroids, immunosuppressants and biologics, many patients still do not respond adequately to these treatments, or gradually lose response over time.

  Upadacitinib is an experimental drug that blocks the actions of proteins involved in the immune response known as Janus kinases (Jaks). Upadacitinib is being studied in patients with UC, Crohn’s disease and other inflammatory diseases. This study will evaluate how well Upadacitinib works within the body and how safe it is compared to placebo (an inactive substance) as an induction treatment for adult patients with moderately to severely active UC. A total of approximately 462 subjects will be enrolled worldwide.

  The study consists of two parts: In Part 1 subjects will be randomly assigned to receive one of the following treatments over an 8 week period. Treatment is blinded meaning neither the subject nor the study Doctor will know what treatment regimen has been assigned.

  • Group 1: Upadacitinib 45mg oral tablet, once daily (QD)
  • Group 2: Placebo oral tablet (QD)

  At the end of Part 1 subject’s whose disease has not improved sufficiently will move to Part 2 for an additional 8 weeks of treatment with Upadacitinib 45mg QD (until Week 16). Subjects will be eligible to enrol into Study M14-234 (Substudy 3) should their disease improve sufficiently at week 8 or week 16. Subjects whose disease does not improve sufficiently at Week 16 will be discontinued from the study and will not be eligible to enrol in M14-234.

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbWTQmAxbAqKaicuQlbAmZ4EyGc0ffQVGjUDUk0IIfbL-2BZ5P3IjJDfO8ntEM11y9j9fB6hMJ-2F7VO4EE3JORyTQE8lnYgQzyZdh2dElonhsFokIWK77-2BS1EH2ftRszBcHv7PUmIlFc-2FWJjYThwqDgQX-2Fg-3D1N4g_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKM0ifDZKZOHj7ej2-2FqR6eJe2IIt93POho3ZNxfE2GSBDEQCgZ-2F2-2BPZ4vnk-2Fd6J6yDbCV41zDJhX1Z6IJQqhsiv-2BEG5qlEa5va2yzwlwBVGYI7Wx14339S3ZLWVg7g3Q0CZGu9pmKVN1zjY-2BB1YOuHW5lbVFKhLxnNC9WDdB-2BZRsw-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C6e47cc703e154911b8d008d9c54274b0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637757711489594855%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=J%2FQ7qNSDcxDsaFbELw8ba1CfUlUBrZME9E2FZvXeues%3D&reserved=0

• REC name

  London - City & East Research Ethics Committee

• REC reference

  19/LO/0820

• Date of REC Opinion

  26 Jul 2019

• REC opinion

  Further Information Favourable Opinion