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
- Recruiting
Trial Condition(s)
- Crohn's Disease
Interventions
- Drug: TEV-48574 | Drug: Placebo
EudraCT Number
- 2021-006881-19
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.
Key Participation Requirements
Gender
- Female, Male
Age Range
- Adult
Trial Duration
- August 29, 2022 - November 08, 2024
Phase
- Phase 2
Study Type
Interventional
