TV48574-IMM-20038 (RELIEVE UCCD LTE)
Research type
Research Study
Full title
A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study
IRAS ID
1007064
Contact name
Stanislav Stoyanov
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Eudract number
2022-002593-89
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 primary objective of the long-term extension study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens (300 mg or 900 mg) of TEV-48574 sc (injection under the skin of the study medication given over time) administered every 2 weeks, for a total of 12 doses, over the course of a 24-week treatment period, in adult patients with IBD (UC or CD) as assessed by maintenance of clinical remission (UC) and endoscopic response (CD). The study is “double-blind,” which means patients and researchers will not know who takes the different TEV-48574 doses.
Approximately 140 male and female adult patients who achieved clinical response and/or clinical remission in study TV48574-IMM-20036 (RELIEVE UCCD) will be screened to achieve approximately 128 randomized patients (approximately 64 patients with UC and 64 patients with CD).REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0126
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion