NCT03464136

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Detailed description

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy; CD-related healthcare utilization; 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 randomly be assigned to receive either ustekinumab or adalimumab. No participants will be treated with placebo only.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BIOLOGICAL	Placebo for Ustekinumab	Participants will receive placebo as SC injection to blind adalimumab.
BIOLOGICAL	Placebo for Adalimumab	Participants will receive placebo as IV infusion to blind ustekinumab.
BIOLOGICAL	Ustekinumab (6 mg/kg)	Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
BIOLOGICAL	Ustekinumab (90 mg)	Participants will self-administer SC injection of ustekinumab 90 mg.
BIOLOGICAL	Adalimumab (40 mg)	Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

Timeline

• Start date: 2018-03-29
• Primary completion: 2020-12-15
• Completion: 2021-05-21
• First posted: 2018-03-13
• Last updated: 2025-04-29
• Results posted: 2022-01-11

Locations

182 sites across 18 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Serbia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study