A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT05029921
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
182 participants
INTERVENTIONAL
2021-12-10
2025-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Ustekinumab
Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.
Interventions
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Ustekinumab
Ustekinumab will be administered as an IV injection in induction phase and as a SC injection in maintenance phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 and is willing to participate in the study
Exclusion Criteria
* Has previously demonstrated lack of initial response (that is, primary nonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to Vedolizumab
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers
* History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly or monoclonal gammopathy of undetermined significance
* Has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Peking University Third Hospital
Beijing, , China
The Military General Hospital of Beijing PLA
Beijing, , China
The second Xiangya Hospital of Central South University
Changsha, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
West China Hospital Sichuan University
Chengdu, , China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Anhui Province Hospital
Hefei, , China
Huzhou central hospital
Huzhou, , China
Jinhua municipal central hospital
Jinhua, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
Zhongda Hospital Southeast University
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
Ningbo medical center lihuili hospital
Ningbo, , China
Huashan Hospital Fudan University
Shanghai, , China
Shanghai 10th Peoples Hospital
Shanghai, , China
Shanghai East Hospital
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Peking University Shenzhen Hospital
Shenzhen, , China
The Second Hospital Affiliated To Suzhou University
Suzhou, , China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Wuxi People s Hospital
Wuxi, , China
Yangzhou First People's Hospital
Yangzhou, , China
Affiliated Hospital of Zunyi Medical University
Zunyi, , China
Countries
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Other Identifiers
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CNTO1275CRD4030
Identifier Type: OTHER
Identifier Source: secondary_id
CR109023
Identifier Type: -
Identifier Source: org_study_id
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