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

NCT05029921 | Completed Phase 4

• 2 other identifiers: CR109023CNTO1275CRD4030
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 29

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint)

  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.

  Week 8

• Percentage of Participants with Endoscopic Response at Week 16 (Co-primary Endpoint)

  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 \[the most severe endoscopic activity\]).

  Week 16

Secondary Outcomes (27)

• Percentage of Participants with Clinical Remission at Week 52 (Major Secondary Endpoint)

  Week 52

• Percentage of Participants with Patient-reported Outcome (PRO)-2 Remission at Week 8 (Major Secondary Endpoint: Co-endpoint)

  Week 8

• Percentage of Participants with Endoscopic Remission at Week 16 (Major Secondary Endpoint: Co-endpoint)

  Week 16

• Percentage of Participants with Endoscopic Response at Week 52

  Week 52

• Percentage of Participants with Endoscopic Remission at Week 52

  Week 52

Study Arms (1)

Ustekinumab

EXPERIMENTAL

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.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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

Also known as: STELARA

Ustekinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and is willing to participate in the study

You may not qualify if:

• Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (29)

Peking University Third Hospital

Beijing, 100191, China

Location

The Military General Hospital of Beijing PLA

Beijing, 100700, China

Location

The second Xiangya Hospital of Central South University

Changsha, 200120, China

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213000, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005, China

Location

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Anhui Province Hospital

Hefei, 230001, China

Location

Huzhou central hospital

Huzhou, 313099, China

Location

Jinhua municipal central hospital

Jinhua, 321000, China

Location

The First Affiliated Hospital of NanChang University

Nanchang, 330006, China

Location

Zhongda Hospital Southeast University

Nanjing, 210000, China

Location

Jiangsu Province Hospital

Nanjing, 210029, China

Location

Ningbo medical center lihuili hospital

Ningbo, 315000, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Shanghai 10th Peoples Hospital

Shanghai, 200072, China

Location

Shanghai East Hospital

Shanghai, 200120, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110004, China

Location

Peking University Shenzhen Hospital

Shenzhen, 518036, China

Location

The Second Hospital Affiliated To Suzhou University

Suzhou, 215168, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, 430030, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

Wuxi People s Hospital

Wuxi, 214023, China

Location

Yangzhou First People's Hospital

Yangzhou, 225001, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, 563000, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: December 10, 2021
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (29)