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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 and is willing to participate in the study.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05029921
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

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.

Interventions

Drug: - Ustekinumab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Third Hospital, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, , 100191

Beijing, China

Status

Recruiting

Address

The Military General Hospital of Beijing PLA

Beijing, , 100700

Changsha, China

Status

Recruiting

Address

The second Xiangya Hospital of Central South University

Changsha, , 200120

West China Hospital, Sichuan University, Chengdu, China

Status

Recruiting

Address

West China Hospital, Sichuan University

Chengdu, , 610041

Fuzhou, China

Status

Recruiting

Address

The First Affiliated Hospital of Fujian Medical University

Fuzhou, , 350005

Guangzhou, China

Status

Recruiting

Address

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , 510080

Guangzhou, China

Status

Recruiting

Address

Guangzhou First Municipal People's Hospital

Guangzhou, , 510180

Guangzhou, China

Status

Recruiting

Address

The 6th Affiliated Hospital of Sun Yat-Sen Hospital

Guangzhou, ,

Hangzhou, China

Status

Recruiting

Address

The Second Affiliated Hospital of Zhejiang University

Hangzhou, , 310003

Hangzhou, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , 310016

Anhui Province Hospital, Hefei, China

Status

Not yet recruiting

Address

Anhui Province Hospital

Hefei, , 230001

Hefei, China

Status

Withdrawn

Address

The 1st affiliated hospital of Anhui Medical University

Hefei, , 230022

Huzhou central hospital, Huzhou, China

Status

Recruiting

Address

Huzhou central hospital

Huzhou, , 313099

Jinhua municipal central hospital, Jinhua, China

Status

Recruiting

Address

Jinhua municipal central hospital

Jinhua, , 321000

Nanchang, China

Status

Recruiting

Address

The First Affiliated Hospital of NanChang University

Nanchang, , 330006

Zhongda Hospital,Southeast University, Nanjing, China

Status

Recruiting

Address

Zhongda Hospital,Southeast University

Nanjing, , 210000

Jiangsu Province Hospital, Nanjing, China

Status

Recruiting

Address

Jiangsu Province Hospital

Nanjing, , 210029

Ningbo medical center lihuili hospital, Ningbo, China

Status

Recruiting

Address

Ningbo medical center lihuili hospital

Ningbo, , 315000

Huashan Hospital Fudan University, Shanghai, China

Status

Recruiting

Address

Huashan Hospital Fudan University

Shanghai, , 200040

Shanghai 10th Peoples Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai 10th Peoples Hospital

Shanghai, , 200072

Shanghai East Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai East Hospital

Shanghai, , 200120

Shenyang, China

Status

Recruiting

Address

Shengjing Hospital of China Medical University

Shenyang, , 110004

Peking University Shenzhen Hospital, Shenzhen, China

Status

Recruiting

Address

Peking University Shenzhen Hospital

Shenzhen, , 518036

Suzhou, China

Status

Recruiting

Address

The Second Hospital Affiliated To Suzhou University

Suzhou, , 215168

Wuhan, China

Status

Recruiting

Address

Tongji Hospital, Tongji Medical College of HUST

Wuhan, , 430030

Renmin Hospital of Wuhan University, Wuhan, China

Status

Recruiting

Address

Renmin Hospital of Wuhan University

Wuhan, , 430060

Wuxi People's Hospital, Wuxi, China

Status

Recruiting

Address

Wuxi People's Hospital

Wuxi, , 214023

Yangzhou First People's Hospital, Yangzhou, China

Status

Recruiting

Address

Yangzhou First People's Hospital

Yangzhou, , 225001

Zunyi, China

Status

Not yet recruiting

Address

Affiliated Hospital of Zunyi Medical University

Zunyi, , 563000

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