RELIEVE UCCD
Research type
Research Study
Full title
A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD)
IRAS ID
1007058
Contact name
Stanislav Stoyanov
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2021-006881-19
Research summary
Inflammatory bowel disease (IBD) is a chronic inflammatory condition of the gastrointestinal (GI) tract that affects 5 million people worldwide. IBD presents as 1 of the 2 major forms, ulcerative colitis (UC) or Crohn’s disease (CD). In UC, the inflammation is confined to the mucosa of the colon (also called the large intestine), while in CD, is caused by inflammation of the entire digestive tract from the mouth to the anus, leading the digestive tract to become swollen and irritated.
The cause of IBD (UC and CD) is not yet known, but evidence has been accumulated to suggest that this is a multifactorial disease in which multiple environmental and genetic factors interact to trigger an excessive and deregulated mucosal immune response that is directed against normal components of the luminal flora and leads to the tissue damage.
In spite of the tremendous advances made in recent years in IBD therapeutics, many patients still do not respond, lose response, or are intolerant to currently available treatments for UC and CD.
The purpose of the study is to determine the pharmacokinetics, efficacy, safety, and tolerability of 3 different dose regimens of TEV-48574 subcutaneously (SC) (injection under the skin of the study medication given over time) administered every 2 weeks (Q2W) in adult patients (18 years of age and above) with moderate to severe UC or CD.
Adult participants will be randomly assigned (by a computer, by chance) in a 1:1:1:1 ratio to one of the following groups:
- TEV-48574 2250 mg (single loading dose)/1800 mg (6 induction doses)
- TEV-48574 2250 mg (single loading dose)/900 mg (6 induction doses)
- TEV-48574 2250 mg (single loading dose)/450 mg (6 induction doses)
- Matching placebo
Approximately 570 participants will be screened to achieve up to 280 participants randomly assigned to study treatment (approximately 140 patients with UC and 140 patients with CD).REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0042
Date of REC Opinion
25 Sep 2023
REC opinion
Further Information Favourable Opinion