A Randomized, Double-Blind, 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 Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)
Teva Identifier
TV48574-IMM-20036
ClinicalTrials.gov Identifier
NCT05499130
Study Status
Completed
Trial Condition(s)
Crohn's Disease
Interventions
Drug: TEV-48574 | Drug: Placebo
EudraCT Number
2021-006881-19
Study Description
Primary objectives: The primary objective is to evaluate the efficacy and dose response of 3 different dose regimens of TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) as assessed by induction of clinical remission (UC) and endoscopic response (CD).
Secondary objectives: To evaluate the efficacy and dose response of the 3 different dose regimens as assessed by multiple standard measures. To evaluate the safety and tolerability of the 3 different dose regimens. To evaluate the immunogenicity of the 3 different dose regimens.
The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
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