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New hope for kids with Crohn's: risankizumab trial launches

NCT ID NCT05995353

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study tests risankizumab, a drug already used in adults, in children aged 2 to 18 with moderate to severe Crohn's disease. About 110 kids will receive the drug intravenously then by injection over several years. The goal is to see if it safely reduces symptoms and gut inflammation.

What this could mean

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

Active substance
risankizumab (a biologic drug that blocks inflammation)
What this could lead to
If successful, this could provide a new treatment option for children with Crohn's disease who haven't responded to other therapies.
What could go wrong
This is an early-phase trial in a small group of children, so results may not apply to all patients. The drug may cause side effects or not work as well as hoped.

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

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

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: * Pediatric individuals, 2 to \< 18 years old * Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at Baseline * Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease) * Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies Exclusion Criteria: * History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class * Any of the following medical disorders: 1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD. 2. A diagnosis of CD prior to 2 years of age. 3. A diagnosis or suspected diagnosis of a primary immunodeficiency. 4. Currently known complications of CD such as: * Active abscess (abdominal or perianal); * Symptomatic bowel strictures; * \> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; * Fulminant colitis; * Toxic megacolon; * Or any other manifestation that might require surgery while enrolled in the study. 5. Ostomy or ileoanal pouch. 6. Diagnosis of short gut or short bowel syndrome. 7. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \>3 bowel resections.

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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's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    81 sites in 20 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP - Hopital Necker /ID# 255608

    RECRUITING

    Paris, 75015, France

  • Aichi Children's Health And Medical Center /ID# 272085

    RECRUITING

    Ōbu, Aichi-ken, 474-8710, Japan

  • Alberta Children's Hospital /ID# 255357

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Amsterdam University Medical Center /ID# 254827

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Arkansas Children's Hospital /ID# 255762

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437

    RECRUITING

    Orlando, Florida, 32806-1141, United States

  • Astrid Lindgrens Barnsjukhus /ID# 255240

    RECRUITING

    Stockholm, Stockholm County, 171 76, Sweden

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044

    RECRUITING

    Messina, 98125, Italy

  • BC Children's Hospital /ID# 255359

    RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • Beijing Children's Hospital /ID# 256081

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Birmingham Women's and Children's NHS Foundation Trust /ID# 255759

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • CHRU Tours - Hopital Gatien de Clocheville /ID# 255052

    RECRUITING

    Tours, Centre-Val de Loire, 37044, France

  • CHU Toulouse - Hopital Paule de Viguier /ID# 255609

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Changhua Christian Hospital /ID# 256082

    RECRUITING

    Changhua City, Changhua County, 50006, Taiwan

  • Children's Hospital Colorado - Aurora /ID# 255764

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Shanghai /ID# 255531

    RECRUITING

    Shanghai, Shanghai Municipality, 200062, China

  • Chu Bordeaux - Hopital Pellegrin /ID# 257060

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Cleveland Clinic - Cleveland /ID# 256453

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinical Research Puerto Rico /ID# 266479

    RECRUITING

    San Juan, 00909-1711, Puerto Rico

  • Cliniques Universitaires UCL Saint-Luc /ID# 255108

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757

    RECRUITING

    London, Greater London, E1 2ES, United Kingdom

  • Dr. von Haunerschen Kinderspital /ID# 255577

    RECRUITING

    Munich, Bavaria, 80337, Germany

  • Edmonton Clinic Health Academy /ID# 255361

    RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • Fakultni nemocnice Motol a Homolka /ID# 256547

    COMPLETED

    Prague, Praha 5, 150 06, Czechia

  • Gastromed Sp. z o.o /ID# 255939

    COMPLETED

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

  • Gazi University Medical Faculty /ID# 255086

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Goryeb Childrens Hospital /ID# 256452

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Groupe Sante CHC - Clinique du MontLegia /ID# 255620

    RECRUITING

    Liège, Liege, 4000, Belgium

  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428

    RECRUITING

    Guangzhou, Guangdong, 510620, China

  • Gunma University Hospital /ID# 270560

    RECRUITING

    Maebashi, Gunma, 371-8511, Japan

  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562

    RECRUITING

    Zhengzhou, Henan, 450018, China

  • Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 255443

    RECRUITING

    Bron, Rhone, 69500, France

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614

    RECRUITING

    Ferrol, A Coruna, 15405, Spain

  • Hospital Infantil Universitario Nino Jesus /ID# 255012

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Malaga /ID# 257553

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Universite Enfants Reine Fabiola /ID# 255112

    RECRUITING

    Brussels, 1020, Belgium

  • Hunan Children's Hospital /ID# 255610

    RECRUITING

    Changsha, Hunan, 410007, China

  • IRCCS Istituto Giannina Gaslini /ID# 255262

    RECRUITING

    Genoa, Genova, 16147, Italy

  • Icahn School of Medicine at Mount Sinai /ID# 254880

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University Health Riley Hospital for Children /ID# 256454

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Inselspital, Universitaetsspital Bern /ID# 255321

    RECRUITING

    Bern, 3010, Switzerland

  • Institute of Science Tokyo Hospital /ID# 269175

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-730, Poland

  • Japanese Red Cross Kumamoto Hospital /ID# 268586

    RECRUITING

    Kumamoto, Kumamoto, 861-8520, Japan

  • Jiangxi Provincial Children's Hospital /ID# 255564

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Kocaeli University Med Faculty /ID# 256922

    RECRUITING

    Kocaeli, 41380, Turkey (Türkiye)

  • Kurume University Hospital /ID# 268418

    RECRUITING

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok Hospital /ID# 255817

    RECRUITING

    Daegu, 41404, South Korea

  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • MNGI Digestive Health, P. A. /ID# 255366

    RECRUITING

    Minneapolis, Minnesota, 55413-2195, United States

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Massachusetts General Hospital - Mass General Waltham /ID# 255767

    RECRUITING

    Waltham, Massachusetts, 02451, United States

  • National Center For Child Health And Development /ID# 268420

    RECRUITING

    Setagaya City, Tokyo, 157-8535, Japan

  • National Taiwan University Hospital /ID# 255679

    RECRUITING

    Taipei, 100, Taiwan

  • Osaka Women's and Children's Hospital /ID# 268419

    RECRUITING

    Izumi-Shi, Osaka, 594-1101, Japan

  • Ospedale Pediatrico Bambino Gesu /ID# 255043

    RECRUITING

    Rome, Roma, 00165, Italy

  • Peking University Third Hospital /ID# 255876

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Phoenix Children's Hospital /ID# 255766

    RECRUITING

    Phoenix, Arizona, 85016-7710, United States

  • Puerto Rico Health Institute /ID# 255071

    RECRUITING

    Dorado, 00646, Puerto Rico

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688

    RECRUITING

    Shanghai, Shanghai Municipality, 200065, China

  • Sahlgrenska Universitetssjukhuset /ID# 255236

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Saitama Children's Medical Center /ID# 268410

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Samsung Medical Center /ID# 255284

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Sariyer Hamidiye Etfal Egitim Ve Araştirma Hastanesi /ID# 257143

    RECRUITING

    Istanbul, 34453, Turkey (Türkiye)

  • Schneider Children's Medical Center /ID# 254950

    RECRUITING

    Petah Tikva, Central District, 4920235, Israel

  • Seoul National University Hospital /ID# 255318

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shaare Zedek Medical Center /ID# 254951

    RECRUITING

    Jerusalem, Jerusalem, 91031, Israel

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 255758

    RECRUITING

    Sheffield, England, S10 2TH, United Kingdom

  • Shengjing Hospital of China Medical University /ID# 255563

    RECRUITING

    Shenyang, Liaoning, 110022, China

  • Sodersjukhuset /ID# 255239

    RECRUITING

    Stockholm, Stockholm County, 118 83, Sweden

  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384

    COMPLETED

    Sofia, 1606, Bulgaria

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Tokyo Metropolitan Children's Medical Center /ID# 268415

    RECRUITING

    Fuchu-shi, Tokyo, 183-8561, Japan

  • Tsujinaka Hospital - Kashiwanoha /ID# 268409

    RECRUITING

    Kashiwa-shi, Chiba, 277-0871, Japan

  • UCSF Benioff Children's Hospital - Oakland /ID# 258327

    RECRUITING

    Oakland, California, 94609, United States

  • UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358

    RECRUITING

    Varna, 9009, Bulgaria

  • UMHAT Sveti Georgi /ID# 255386

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Universitaetsklinikum Muenster - Albert Schweitzer Campus /ID# 256762

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universitair Ziekenhuis Brussel /ID# 255109

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • Universitair Ziekenhuis Leuven /ID# 255098

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University Childrens Hospital Zurich - Eleonorenstiftung /ID# 255337

    RECRUITING

    Zurich, Canton of Zurich, 8032, Switzerland

  • Uza /Id# 255114

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Vseobecna Fakultni nemocnice v Praze /ID# 256096

    COMPLETED

    Prague, Praha 17, 128 00, Czechia

  • Yonsei University Health System Severance Hospital /ID# 256976

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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