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
- EU CT Number
- 2024-511089-36-00
- 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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult
- Age Range
- Adult
- Trial Duration
- September 30, 2022 - November 12, 2024
- Phase
- Phase 2
