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 IBDEvaluate 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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult
- Age Range
- Adult
- Trial Duration
- January 11, 2023 - March 08, 2031
- Phase
- Phase 3