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New hope for kids with colitis: risankizumab trial launches

NCT ID NCT07071519

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 25 times

Summary

This phase 3 study tests the drug risankizumab in about 120 children aged 2 to 18 with moderate to severe ulcerative colitis. The trial has three parts: an initial 12-week IV treatment period, a 52-week maintenance phase where patients get one of two doses by injection, and a long-term extension. Researchers will check how the drug moves through the body, its safety, and whether it helps control the disease.

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 drug given as an IV infusion or subcutaneous injection)
What this could lead to
If successful, this could provide a new treatment option for children with ulcerative colitis, helping control inflammation and improve symptoms.
What could go wrong
This is still being tested in children, so safety and effectiveness are not yet confirmed. Side effects may occur, and not all participants 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

About 120 people

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

Started

Jul 2025

Expected to finish

Jul 2034

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: * Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader). * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol. \- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available. Exclusion Criteria: * Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection). * Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis

How to take part

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

  1. The places running it

    64 sites in 15 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

  • Addenbrookes Hospital /ID# 271489

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Aichi Children's Health And Medical Center /ID# 280462

    RECRUITING

    Ōbu, Aichi-ken, 474-8710, Japan

  • Alberta Children's Hospital /ID# 272635

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Alder Hey Children's NHS Foundation Trust /ID# 271533

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895

    RECRUITING

    Naples, Napoli, 80131, Italy

  • Centre Hospitalier Regional de la Citadelle /ID# 270459

    RECRUITING

    Liège, 4000, Belgium

  • Childrens Center For Digestive Health Care /ID# 273228

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Cliniques Universitaires UCL Saint-Luc /ID# 270123

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Edmonton Clinic Health Academy /ID# 271168

    RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967

    RECRUITING

    Rome, Roma, 00168, Italy

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889

    RECRUITING

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Galileo Medical Research /ID# 271817

    RECRUITING

    Juiz de Fora, Minas Gerais, 36033-318, Brazil

  • General Hospital of Thessaloniki Hippokrateio /ID# 271939

    RECRUITING

    Thessaloniki, 54642, Greece

  • Goryeb Children's Hospital /ID# 271801

    RECRUITING

    Morristown, New Jersey, 07962, United States

  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962

    RECRUITING

    Guangzhou, Guangdong, 510620, China

  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794

    RECRUITING

    Zhengzhou, Henan, 450018, China

  • Hospital Pequeno Principe /ID# 271814

    RECRUITING

    Curitiba, Paraná, 80250-060, Brazil

  • Hospital Sirio Libanes - Sao Paulo /ID# 271818

    RECRUITING

    São Paulo, 01308-050, Brazil

  • Hospital Teresa Herrera - CHUAC /ID# 271459

    RECRUITING

    A Coruña, A Coruna, 15006, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universite Enfants Reine Fabiola /ID# 271860

    RECRUITING

    Brussels, 1020, Belgium

  • Hunan Children's Hospital /ID# 278111

    RECRUITING

    Changsha, Hunan, 410007, China

  • Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696

    RECRUITING

    Belgrade-Vračar, Beograd, 11000, Serbia

  • Institute for Child and Youth Health Care of Vojvodina /ID# 269961

    RECRUITING

    Novi Sad, 21000, Serbia

  • Institute of Science Tokyo Hospital /ID# 280694

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Japanese Red Cross Kumamoto Hospital /ID# 280696

    RECRUITING

    Kumamoto, Kumamoto, 861-8520, Japan

  • Juntendo University Hospital /ID# 280463

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kangbuk Samsung Hospital /ID# 273333

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03181, South Korea

  • Karolinska University Hospital Solna /ID# 271679

    RECRUITING

    Solna, Stockholm County, 171 64, Sweden

  • Klinikum Kassel /ID# 271546

    RECRUITING

    Kassel, Hesse, 34125, Germany

  • Kobe University Hospital /ID# 281796

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023

    RECRUITING

    Cottbus, Brandenburg, 03048, Germany

  • National Taiwan University Hospital /ID# 269244

    RECRUITING

    Taipei, 100, Taiwan

  • Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue /ID# 271585

    RECRUITING

    Miami, Florida, 33155, United States

  • Ospedale Infantile Burlo Garofolo /ID# 274442

    RECRUITING

    Trieste, 34137, Italy

  • Patewood Medical Campus /ID# 272477

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Phoenix Children's Hospital /ID# 273015

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Pusan National University Yangsan Hospital /ID# 272769

    RECRUITING

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Rady Children's Hospital /ID# 271873

    RECRUITING

    San Diego, California, 92123, United States

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Saga University Hospital /ID# 281232

    RECRUITING

    Saga, Saga-ken, 849-8501, Japan

  • Sahlgrenska Universitetssjukhuset /ID# 271675

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Saitama Children's Medical Center /ID# 280603

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Samsung Medical Center /ID# 272862

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 272852

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 271490

    RECRUITING

    Sheffield, England, S10 2TH, United Kingdom

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994

    RECRUITING

    Hangzhou, Zhejiang, 310018, China

  • Sodersjukhuset /ID# 271678

    RECRUITING

    Stockholm, Stockholm County, 118 83, Sweden

  • Taichung Veterans General Hospital /ID# 269242

    RECRUITING

    Taichung, 407, Taiwan

  • The Children's Hospital of Philadelphia /ID# 273222

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815

    RECRUITING

    Hangzhou, Zhejiang, 310056, China

  • The First Hospital of Jilin University - Changchun /ID# 279290

    RECRUITING

    Changchun, Jilin, 130021, China

  • Thoracic General Hospital of Athens I Sotiria /ID# 270143

    RECRUITING

    Athens, Attica, 11527, Greece

  • Tsujinaka Hospital - Kashiwanoha /ID# 280303

    RECRUITING

    Kashiwa-shi, Chiba, 277-0871, Japan

  • Universitaetsklinikum Muenster - Albert Schweitzer Campus /ID# 271898

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Children's Hospital /ID# 269960

    RECRUITING

    Belgrade, Beograd, 11000, Serbia

  • University General Hospital Attikon /ID# 272361

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • University Hospitals Cleveland Medical Center /ID# 271831

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California San Francisco - Mission Bay /ID# 273022

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center /ID# 271588

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Texas - Southwestern Medical Center /ID# 271835

    RECRUITING

    Dallas, Texas, 75235, United States

  • Upmc Children'S Hospital Of Pittsburgh /ID# 272328

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Yonsei University Health System Severance Hospital /ID# 272894

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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