Study ID: TV48574-IMM-20036

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

Not yet recruiting

Trial Condition(s)

Crohn's Disease

Interventions

Drug: TEV-48574 | Drug: Placebo

Study Description

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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Key Participation Requirements

Gender

Female, Male

Age Range

Adult

Phase

Phase 2

Study Type

Interventional