drugset / Trial / NCT04629196

Induction Optimization With Stelara for Crohn's Disease

NCT04629196

Phase 4 Terminated 12 enrolled NYU Langone Health
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.

Timeline

Start
2022-02-16
Primary completion
2024-01-17
Completion
2024-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody 90 mg Intravenous
Subject Ustekinumab Monoclonal antibody 260 mg Intravenous
Subject Ustekinumab Monoclonal antibody 390 mg Intravenous
Subject Ustekinumab Monoclonal antibody 520 mg Intravenous

Indications