A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05029921
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.

Study Details

The purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in Chinese participants with moderately to severely active Crohn's disease.

Key Dates

Start date
Dec 10, 2021
Status verified
Sep 2025
Primary completion
May 18, 2025
Completion
May 18, 2025

Study Design

Enrollment
182 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ustekinumab
    Participants will receive a single dose of ustekinumab intravenously (IV) (weight-based dose approximating 6 milligrams per kilogram \[mg/kg\]) at Week 0. Participants with body weight less than or equal to (\<=) 55 kg will receive ustekinumab IV of 260 mg, greater than (\>) 55 kg and \<=85 kg will receive ustekinumab IV of 390 mg, and \>85 kg will receive ustekinumab IV of 520 mg at Week 0 in induction phase followed by ustekinumab 90 mg subcutaneously (SC) in maintenance phase from Week 8 to Week 52. For participants who achieve clinical response with ustekinumab induction dosing at Week 8, will continue to receive 90 mg ustekinumab SC every 12 weeks with final dose at Week 44. If these participants meet the criteria for loss of response from Week 16 to Week 40, dose can be adjusted to 90 mg every 8 weeks (q8w). Participants who are non-responders to ustekinumab at Week 8, and achieve clinical response at Week 16, will continue to receive ustekinumab 90 mg SC q8w from Week 16 to Week 48.

Primary Outcome Measure

Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint) [ Time Frame: Week 8 ]

Related Studies