Long-Term Effect of TEV-48574 in Ulcerative Colitis or Crohn's Disease

Study Title
A 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 (RELIEVE UCCD LTE)
Teva Identifier
TV48574-IMM-20038
ClinicalTrials.gov Identifier
NCT05668013
Study Status
Active, not recruiting
Trial Condition(s)
Crohn's Disease, Colitis, Ulcerative
Interventions
Drug: TEV-48574
EudraCT Number
2022-002593-89
EU CT Number
2024-515027-11-00

Study Description

Primary objectives:
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).

Secondary objective:
- Evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- Evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
- Evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

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Participation criteria and map of study locations

EudraCT

CTIS


Key Participation Requirements

Gender
Female, Male
Age group
Adult
Age Range
Adult
Trial Duration
January 11, 2023 - March 08, 2031
Phase
Phase 3

Study Type

Interventional