Completed
PHASE4
INTERVENTIONAL
NCT05029921
A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
Ustekinumab
Type:
DRUG
Description:
Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.
Primary Outcomes
Measure:
Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)
TimeFrame:
Week 8
Description:
Clinical remission is defined as a crohn's disease activity index (CDAI) score of less than (\<) 150 (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid or very soft stools, abdominal pain \[AP\]/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card that participants are to complete on a daily basis.
Measure:
Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)
TimeFrame:
Week 16
Description:
Endoscopic response is defined as at least 50 percent (%) improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or SES-CD score less than or equal to (\<=) 2. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, percentage of mucosal surface covered by ulcers, the percentage of affected surface, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 \[remission\] to 56 \[the most severe endoscopic activity\]).
Trial Information
NCT ID
NCT05029921
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Janssen Research & Development, LLC
Last Updated
December 15, 2025