A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn… (NCT05029921) | Clinical Trial Compass
CompletedPhase 4
A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
China182 participantsStarted 2021-12-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed in the past by radiography, histology, and/or endoscopy
* Have moderately to severely active CD, defined as a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (\>=) 220 and less than or equal to (\<=) 450, and either: a. Mean daily stool frequency (SF) count \>3, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily abdominal pain (AP) score \>1, based on the unweighted CDAI component of AP
* Have endoscopic evidence of active ileocolonic CD as assessed by central endoscopy reading at the screening endoscopy, defined as a screening simple endoscopic score for crohn's disease (SES-CD) score \>=6 (or \>=4 for participants with isolated ileal disease), based on the presence of ulceration in at least 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. a minimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface"
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test at baseline
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study…
What they're measuring
1
Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)
Timeframe: Week 8
2
Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)