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Crohn DiseasePhase 4NCT05029921

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

A Phase 4 study testing Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 29 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
29 sitesChina
Study dates
10 Dec 2021to 18 May 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Peking University Third Hospital

    Beijing, 100191

  • The Military General Hospital of Beijing PLA

    Beijing, 100700

  • The second Xiangya Hospital of Central South University

    Changsha, 200120

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213000

  • West China Hospital Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Anhui Province Hospital

    Hefei, 230001

  • Huzhou central hospital

    Huzhou, 313099

  • Jinhua municipal central hospital

    Jinhua, 321000

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Zhongda Hospital Southeast University

    Nanjing, 210000

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Ningbo medical center lihuili hospital

    Ningbo, 315000

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Shanghai 10th Peoples Hospital

    Shanghai, 200072

  • Shanghai East Hospital

    Shanghai, 200120

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

  • The Second Hospital Affiliated To Suzhou University

    Suzhou, 215168

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People s Hospital

    Wuxi, 214023

  • Yangzhou First People's Hospital

    Yangzhou, 225001

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563000

Other trials in China

About this study

Official title: A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease

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
Being tested
Ustekinumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called STELARA

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

Study groups in NCT05029921
Study groupRoleWhat they receive
UstekinumabExperimentalParticipants 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.
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 8

  2. 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]).

    Measured: Week 16

Secondary outcomes (27)

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

    Percentage of participants with clinical remission at Week 52 will be reported.

    Measured: Week 52

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

    PRO-2 remission is defined as an AP mean daily score at or below 1 (AP<=1) and a stool frequency (SF) mean daily score at or below 3 (SF<=3), and no worsening of AP or SF from baseline.

    Measured: Week 8

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

    Endoscopic remission is defined as SES-CD score of <= 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]).

    Measured: Week 16

  4. Percentage of Participants with Endoscopic Response at Week 52

    Percentage of participants with endoscopic response at Week 52 will be reported.

    Measured: Week 52

  5. Percentage of Participants with Endoscopic Remission at Week 52

    Percentage of participants with endoscopic remission at Week 52 will be reported.

    Measured: Week 52

  6. Percentage of Participants with Clinical Remission at Week 3

    Percentage of participants with clinical remission at Week 3 will be reported.

    Measured: Week 3

  7. Percentage of Participants with PRO-2 Remission at Weeks 3 and 52

    Percentage of participants with PRO-2 remission at Weeks 3 and 52 will be reported.

    Measured: Weeks 3 and 52

  8. Percentage of Participants with Clinical Response at Weeks 3, 8, and 52

    Clinical response is defined as a CDAI score decrease greater than or equal to (>=) 100 from baseline. Participants with a baseline CDAI score of >=220 to <=248 points are considered to be in clinical response if a CDAI score of <150 is attained.

    Measured: Weeks 3, 8, and 52

  9. Percentage of Participants with Clinical Remission at Week 52 (in Participants Induced into Clinical Remission with Ustekinumab at Week 8)

    Percentage of participants with clinical remission at Week 52 (in participants induced into clinical remission with ustekinumab at Week 8) will be reported.

    Measured: Week 52

  10. Percentage of Participants with Corticosteroid-free Remission at Week 52

    Corticosteroid-free remission is defined as a CDAI score <150 and not taking any corticosteroids for at least 30 days or 90 days prior to Week 52.

    Measured: Week 52

  11. Change from Baseline in C-reactive Protein (CRP) Concentration at Week 3, Week 8, and Week 52

    Change from baseline in CRP concentration at Week 3, Week 8, and Week 52 will be reported.

    Measured: Baseline, Week 3, Week 8, and Week 52

  12. Percentage of Participants with Normalization of CRP at Weeks 3, 8, and 52

    Percentage of participants with normalization of CRP at Weeks 3, 8, and 52 with elevated CRP (>3.0 milligrams per liter [mg/L]) at baseline will be reported.

    Measured: Weeks 3, 8, and 52

  13. Change from Baseline in Fecal Calprotectin Concentration at Week 8 and Week 52

    Change from baseline in fecal calprotectin concentration at Week 8 and Week 52 will reported. Fecal Calprotectin will be monitored as an inflammatory biomarker measured by assay.

    Measured: Baseline, Week 8, and Week 52

  14. Percentage of Participants with Normalization of Fecal Calprotectin at Weeks 8 and 52

    Percentage of participants with normalization of fecal calprotectin at Weeks 8 and 52 with elevated fecal calprotectin (>250 milligrams per kilograms [mg/kg]) at baseline will be reported.

    Measured: Weeks 8 and 52

  15. Percentage of Participants with Fistula Response at Weeks 8 and 52

    Fistula response is defined as a >=50% reduction in the number of draining fistulas, among participants with 1 or more fistulas at baseline.

    Measured: Weeks 8 and 52

  16. Percentage of Participants with Clinical Remission of Delayed Responders at Week 52

    Percentage of participants with clinical remission of delayed responders at Week 52 will be reported. Delayed responders are participants who are not in clinical response to ustekinumab at Week 8 and achieve clinical response at Week 16.

    Measured: Week 52

  17. Percentage of Participants with PRO-2 Remission of Delayed Responders at Week 52

    Percentage of participants with PRO-2 remission of delayed responders at Week 52 will be reported.

    Measured: Week 52

  18. Percentage of Participants with Clinical Response of Delayed Responders at Week 52

    Percentage of participants with clinical response of delayed responders at Week 52 will be reported.

    Measured: Week 52

  19. Percentage of Participants with Endoscopic Response of Delayed Responders at Week 52

    Percentage of participants with endoscopic response of delayed responders at Week 52 will be reported.

    Measured: Week 52

  20. Percentage of Participants with Endoscopic Remission of Delayed Responders at Week 52

    Percentage of participants with endoscopic remission of delayed responders at Week 52 will be reported.

    Measured: Week 52

  21. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8 and Week 52

    IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD to evaluate PROs across 4 dimensions: bowel symptoms (loose stools, AP), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: Baseline, Week 8 and Week 52

  22. Percentage of Participants with IBDQ Response at Weeks 8 and 52

    Percentage of participants with IBDQ response (>=16-point improvement from baseline) at Weeks 8 and 52 will be reported.

    Measured: Weeks 8 and 52

  23. Percentage of Participants with IBDQ Remission at Weeks 8 and 52

    Percentage of participants with IBDQ remission (>170-point) at Weeks 8 and 52 will be reported.

    Measured: Weeks 8 and 52

  24. Percentage of Participants Having any Crohn's Disease (CD)-related Emergency Room (ER)/Hospitalizations (Including Surgeries) Through Week 8 and Week 52

    Percentage of participants having any CD-related ER/hospitalizations (including surgeries) through Week 8 and Week 52 will be reported.

    Measured: Weeks 8 and 52

  25. Percentage of Participants Having any CD-related Surgery and Procedure Through Week 8 and Week 52

    Percentage of participants having any CD-related surgery and procedure through Week 8 and Week 52 will be reported.

    Measured: Weeks 8 and 52

  26. Change from Baseline in Each of 4 Impairments from Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI-CD) at Week 8 and Week 52

    The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.

    Measured: Baseline, Week 8, and Week 52

  27. Percentage of Participants with a 7-point Change from Baseline in Each of 4 Impairments from WPAI-CD at Week 8 and Week 52

    The WPAI-CD is a validated instrument created as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to CD. The WPAI-CD consists of 6 questions to determine employment status, hours missed from work due to Crohn's disease, hours missed from work for other reasons, hours worked, the degree to which Crohn's disease affected work productivity while at work, and the degree to which Crohn's disease affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each of the four scores ranges from 0 to 100, with higher scores indicate greater impairment.

    Measured: Baseline, Week 8, and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start10 Dec 2021
  3. Primary completion18 May 2025
  4. Study completion18 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029921
Sponsor's protocol ID
CR109023
Other IDs
CNTO1275CRD4030
Status last verified
Sep 2025
First submitted
30 Aug 2021
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ustekinumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Clinical Remission at Week 8 (Co-primary Endpoint) (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05029921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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