Study ID: TV48574-IMM-20038

Study Title

A 24-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the main phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

Teva Identifier

2022-002593-89

ClinicalTrials.gov Identifier

NCT05668013

Study Status

Not yet recruiting

Trial Condition(s)

Crohn's Disease Colitis, Ulcerative

Interventions

Drug: TEV-48574

Study Description

The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD) Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months..


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Key Participation Requirements

Gender

Female, Male

Age Range

Adult

Trial Duration

January 16, 2023 - August 30, 2025

Phase

Phase 3

Study Type

Interventional