At a glance
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A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Ustekinumab approximately 6 mg/kg (IV), Placebo (SC), and 3 other interventions for Crohn Disease. Completed, enrolled 215 participants across 104 sites in 12 countries.
Detailed Summary
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Study Details
Timeline
Interventions
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Participants will receive SC injection of placebo at Week 0.
Participants will receive IV infusion of placebo at Week 0.
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.