NCT03782376

A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Ustekinumab approximately 6 mg/kg (IV)	Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
DRUG	Placebo (SC)	Participants will receive SC injection of placebo at Week 0.
DRUG	Placebo (IV)	Participants will receive IV infusion of placebo at Week 0.
DRUG	Ustekinumab 90 mg (SC) Group 1	Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
DRUG	Ustekinumab 90 mg (SC) Group 2	Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.

Timeline

• Start date: 2018-12-20
• Primary completion: 2022-08-19
• Completion: 2023-01-10
• First posted: 2018-12-20
• Last updated: 2025-04-29
• Results posted: 2023-09-13

Locations

104 sites across 12 countries: United States, Austria, Czechia, France, Germany, Italy, Netherlands, Russia, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study