A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
The primary objective of the study is to evaluate the efficacy of 2 different maintenancedose regimens of TEV‐48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adultparticipants with inflammatory bowel disease (IBD).Secondary objectives of the study are to: ‐ evaluate the efficacy of 2 different maintenance dose regimens of TEV‐48574 scadministered Q4W in adult participants with IBD ‐ evaluate the safety and tolerability of 2 different maintenance dose regimens ofTEV‐48574 sc administered Q4W in adult participants with IBD ‐ evaluate the immunogenicity of 2 different maintenance dose regimens of TEV‐48574 scadministered Q4W in adult participants with IBDThe total duration for a participant in the double‐blind period only is 66 weeks; and fora participant in the open‐label extension (OLE) period, up to an additional 268 weeks.
Epistemonikos ID: 9402a7b6cb9552334382162d48c69ee72b46ec9d
First added on: Oct 02, 2023