Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Study Title
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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Participation criteria and map of study locations

EudraCT


Key Participation Requirements

Gender
Female, Male
Age Range
Adult
Trial Duration
August 29, 2022 - November 12, 2024
Phase
Phase 2

Study Type

Interventional