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New hope for Crohn's: ustekinumab trial targets chinese patients

NCT ID NCT05029921

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the drug ustekinumab (STELARA) in 182 Chinese adults with moderate-to-severe Crohn's disease. The goal was to see if the drug could reduce symptoms and heal the gut lining over 52 weeks. Participants received the drug by IV and later by injection, and researchers tracked remission and endoscopic improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ustekinumab (STELARA)
What this could lead to
If successful, this could confirm that ustekinumab is a safe and effective treatment option for Chinese patients with moderate-to-severe Crohn's disease.
What could go wrong
This is a single-arm, open-label study with no placebo group, so results may be less reliable. Side effects like infections or allergic reactions are possible, and long-term benefits are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

182 people

The number who actually took part.

Started

Dec 2021

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563000, China

  • Anhui Province Hospital

    Hefei, 230001, China

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213000, China

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180, China

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Huzhou central hospital

    Huzhou, 313099, China

  • Jiangsu Province Hospital

    Nanjing, 210029, China

  • Jinhua municipal central hospital

    Jinhua, 321000, China

  • Ningbo medical center lihuili hospital

    Ningbo, 315000, China

  • Peking University Shenzhen Hospital

    Shenzhen, 518036, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Renmin Hospital of Wuhan University

    Wuhan, 430060, China

  • Shanghai 10th Peoples Hospital

    Shanghai, 200072, China

  • Shanghai East Hospital

    Shanghai, 200120, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016, China

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005, China

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006, China

  • The Military General Hospital of Beijing PLA

    Beijing, 100700, China

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • The Second Hospital Affiliated To Suzhou University

    Suzhou, 215168, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, China

  • The second Xiangya Hospital of Central South University

    Changsha, 200120, China

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030, China

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Wuxi People s Hospital

    Wuxi, 214023, China

  • Yangzhou First People's Hospital

    Yangzhou, 225001, China

  • Zhongda Hospital Southeast University

    Nanjing, 210000, China

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