A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
Status:
Not yet recruiting
Trial end date:
2024-10-10
Target enrollment:
Participant gender:
Summary
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.