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New hope for kids with Crohn's: drug aims to tame gut inflammation

NCT ID NCT04673357

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tested whether ustekinumab, a drug that blocks inflammation, can help children aged 2 to 17 with moderate-to-severe Crohn's disease. 101 participants first received the drug through an IV, then some continued with injections while others got a placebo. The goal was to see if the drug could bring about remission (fewer symptoms) and keep it going, while also checking for side effects.

What this could mean

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

Active substance
ustekinumab
What this could lead to
If successful, this could provide a new treatment option to help children with Crohn's disease achieve and maintain remission, reducing symptoms and improving daily life.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Ustekinumab may cause side effects like infections or infusion reactions, and not all children may respond.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

101 people

The number who actually took part.

Started

Apr 2021

Finished

Mar 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

2 to 17 years

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 or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology * Must have moderately to severely active Crohn's disease (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than \[\>\] 30); have ileocolonoscopy with evidence of active Crohn's disease defined as presence of ulceration (which is equal to Simple Endoscopic Score for Crohn's disease \[SES-CD\] score greater than or equals to \[\>=\] 3) during screening into this study. The ileocolonoscopy procedure must occur within approximately 3 weeks prior to the administration of study intervention at Week 0 (Induction Period). A video ileocolonoscopy recorded within 3 months prior to the Week 0 (Induction Period) visit may be used in case of rescreening of a participant who had an ileocolonoscopy but failed the initial screening for another reason, on a case-by-case basis, after consultation with the sponsor. If unable to evaluate ulceration due to stricture or inadequate bowel preparation, at least one of the following criteria may instead be applied: an abnormal C-reactive protein (CRP) (\> 0.3 milligram per deciliter \[mg/dL\] or 3.0 milligram per liter \[mg/L\] at screening) or; fecal calprotectin of \>= 250 milligram per kilogram \[mg/kg\] or \>= 250 microgram per gram \[mcg/g\] at screening * If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to induction week 0 (Week I-0) * Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration Exclusion Criteria: * Has complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of treatment with ustekinumab * Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening * Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly * Have a history of moderate or severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic disturbances * Received an investigational intervention including any investigational vaccines or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or is currently enrolled in an investigational study; receipt of an investigational vaccine for Coronavirus Disease 2019 (COVID-19) is not an automatic exclusion criterion

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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

  • Birmingham Children's Hospital

    Birmingham, B4 6NH, United Kingdom

  • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Charite-Universitätsmedizin Berlin - Berlin

    Berlin, 13353, Germany

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342, United States

  • Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104, United States

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Dr. von Haunersches Kinderspital

    Munich, 80337, Germany

  • Gunma University Hospital

    Gunma, 371-0034, Japan

  • Instytut Pomnik Centrum Zdrowia Dziecka

    Warsaw, 04 730, Poland

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498, Japan

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • KUNO Klinik St. Hedwig

    Regensburg, 93049, Germany

  • Kazan State Medical University

    Kazan', 420138, Russia

  • Kindai University Nara Hospital

    Ikoma, 630-0293, Japan

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302, Poland

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Levine Childrens at Atrium Health

    Charlotte, North Carolina, 28207, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Mie University Hospital

    Tsu, 514 8507, Japan

  • Miyagi Children's Hospital

    Sendai, 989-3126, Japan

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962, United States

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535, Japan

  • Nemours DuPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Pediatric Specialists Of Virginia

    Fairfax, Virginia, 22031, United States

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033, United States

  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation

    Nizhny Novgorod, 603950, Russia

  • Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ, United Kingdom

  • Royal London Hospital

    London, E1 2AT, United Kingdom

  • Russian National Research Medical University named after N.I.Pirogov

    Moscow, 119571, Russia

  • Saitama Childrens Medical Center

    Saitama Shi, 330-8777, Japan

  • Schneider Children's Medical Center

    Petah Tikva, 4920235, Israel

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

    Nyíregyháza, 4400, Hungary

  • Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

    Szeged, 6720, Hungary

  • Szpital im. M. Kopernika

    Gdansk, 80 803, Poland

  • UZ Brussel

    Jette, 1090, Belgium

  • UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitair Kinderziekenhuis Koningin Fabiola

    Brussels, 1020, Belgium

  • Universitatsklinikum Essen

    Essen, 45147, Germany

  • Universitatsklinikum Ulm

    Ulm, 89075, Germany

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8BJ, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Universitätsklinikum Aachen

    Aachen, 52074, Germany

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30 663, Poland

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501, Poland

  • Yaroslavl Regional Children's Clinical Hospital

    Yaroslavl, 150032, Russia

  • Yitzhak Shamir Medical Center

    Be’er Ya‘aqov, 70300, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.