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New hope for kids with Crohn's: oral drug trial launches

NCT ID NCT06332534

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests upadacitinib (RINVOQ), a daily oral medication, in 110 children aged 2 to 18 with moderate to severe Crohn's disease who haven't improved with other treatments. The trial has three parts: an initial 12-week open-label phase, a 52-week double-blind maintenance phase, and a 156-week open-label extension. Researchers will measure symptom improvement, endoscopic healing, and 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
upadacitinib (RINVOQ)
What this could lead to
If successful, this could provide a new oral treatment option for children with hard-to-control Crohn's disease, potentially reducing symptoms and improving quality of life.
What could go wrong
This is an early-phase trial in a small group of children. The drug may not work as well in kids as it does in adults, and side effects could be serious. Long-term safety is still unknown.

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

Aug 2024

Expected to finish

Dec 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: * Weight at Screening and Baseline must be \>= 10 kg * Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) \> 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of \>= 6 (or SES-CD of \>=4 for isolated ileal disease) excluding the presence of narrowing component. * Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available * Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and/or biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor). Exclusion Criteria: * History of: * A diagnosis of CD prior to 2 years of age. * Currently known complications of CD such as: * Active abscess (abdominal or perianal); * Symptomatic bowel strictures; * More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; * Ostomy or ileoanal pouch; * Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections. * Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection) * History of any of the following: * Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD); * Fulminant colitis or toxic megacolon; * Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and/or intussusception (telescoping of bowels); * Current diagnosis of any primary immune deficiency * Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded.

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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 18 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# 262707

    RECRUITING

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Agia Sofia Hospital /ID# 261792

    RECRUITING

    Athens, Attica, 11527, Greece

  • Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380

    RECRUITING

    Messina, 98125, Italy

  • BC Children's Hospital /ID# 262237

    RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • Beijing Children's Hospital /ID# 262258

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Boston Children's Hospital /ID# 262191

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHR de la Citadelle /ID# 261749

    RECRUITING

    Liège, 4000, Belgium

  • CHU Sainte-Justine /ID# 262096

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311

    RECRUITING

    Caen, Calvados, 14033, France

  • Children's Hospital Colorado - Aurora /ID# 262207

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital at Westmead /ID# 262350

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Philadelphia - Main /ID# 262197

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Children's Hospital of Shanghai /ID# 262356

    RECRUITING

    Shanghai, Shanghai Municipality, 200062, China

  • Christchurch Hospital. /ID# 262577

    RECRUITING

    Christchurch, Canterbury, 8011, New Zealand

  • Clinical Research Investigator Group /ID# 262357

    RECRUITING

    Bayamón, 00960, Puerto Rico

  • Clinical Research Puerto Rico /ID# 279595

    RECRUITING

    San Juan, 00909-1711, Puerto Rico

  • Cliniques Universitaires UCL Saint-Luc /ID# 261741

    RECRUITING

    Brussels, Brussels Capital, 1200, Belgium

  • Connecticut Children's Medical Center - Hartford /ID# 262256

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811

    RECRUITING

    London, Greater London, E1 2ES, United Kingdom

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 275276

    RECRUITING

    Milan, 20122, Italy

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384

    RECRUITING

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Galileo Medical Research Ltda /ID# 262602

    RECRUITING

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

  • Gastromed Sp. z o.o /ID# 262367

    RECRUITING

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

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790

    RECRUITING

    Athens, Attica, 11527, Greece

  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596

    RECRUITING

    Guangzhou, Guangdong, 510620, China

  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300

    RECRUITING

    Zhengzhou, Henan, 450018, China

  • Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308

    COMPLETED

    Paris, 75019, France

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 263422

    RECRUITING

    Bron, Rhone, 69500, France

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226

    RECRUITING

    Ferrol, A Coruna, 15405, Spain

  • Hospital Clinico Universitario Lozano Blesa /ID# 262227

    COMPLETED

    Zaragoza, 50009, Spain

  • Hospital Pequeno Príncipe /ID# 262600

    RECRUITING

    Curitiba, Paraná, 80250-060, Brazil

  • Hospital Regional Universitario de Malaga /ID# 262228

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Sant Joan de Deu /ID# 262599

    COMPLETED

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Sirio Libanes - Sao Paulo /ID# 262670

    RECRUITING

    São Paulo, 01308-050, Brazil

  • Hospital Universitario Virgen del Rocio /ID# 262712

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universite Enfants Reine Fabiola /ID# 261744

    RECRUITING

    Brussels, 1020, Belgium

  • Hunan Children's Hospital /ID# 262512

    RECRUITING

    Changsha, Hunan, 410007, China

  • IWK Health Center /ID# 262543

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Icahn School of Medicine at Mount Sinai /ID# 262216

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University Health Riley Hospital for Children /ID# 262215

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institute of Science Tokyo Hospital /ID# 262510

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-730, Poland

  • Jiangxi Provincial Children's Hospital /ID# 262295

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Kurume University Hospital /ID# 262455

    RECRUITING

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 261696

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Lucile Packard Children's Hospital /ID# 262193

    RECRUITING

    Palo Alto, California, 94304, United States

  • MNGI Digestive Health, P. A. /ID# 262204

    RECRUITING

    Minneapolis, Minnesota, 55413-2195, United States

  • Miyagi Children's Hospital /ID# 262459

    RECRUITING

    Sendai, Miyagi, 989-3126, Japan

  • Monash Health - Monash Medical Centre - Clayton /ID# 262878

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Center For Child Health And Development /ID# 262456

    RECRUITING

    Setagaya City, Tokyo, 157-8535, Japan

  • National Taiwan University Hospital /ID# 261695

    RECRUITING

    Taipei, 100, Taiwan

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778

    RECRUITING

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • OSF St. Francis Medical Center /ID# 262192

    RECRUITING

    Peoria, Illinois, 61637-0001, United States

  • Osaka Women's and Children's Hospital /ID# 262549

    RECRUITING

    Izumi-Shi, Osaka, 594-1101, Japan

  • Ospedale Pediatrico Bambino Gesù /ID# 262379

    RECRUITING

    Rome, Roma, 00165, Italy

  • Perth Children'S Hospital /ID# 272905

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Puerto Rico Health Institute /ID# 262358

    RECRUITING

    Dorado, 00646, Puerto Rico

  • Queensland Children's Hospital /ID# 262351

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Rocco & Nazato Servicos Medicos /ID# 262485

    RECRUITING

    São Paulo, São Paulo, 04543-011, Brazil

  • Royal Hospital for Children and Young People /ID# 262388

    RECRUITING

    Edinburgh, EH16 4TJ, United Kingdom

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502

    RECRUITING

    Shanghai, Shanghai Municipality, 200065, China

  • Saga University Hospital /ID# 262753

    RECRUITING

    Saga, Saga-ken, 849-8501, Japan

  • Saitama Children's Medical Center /ID# 262461

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Samsung Medical Center /ID# 262323

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Santo Antônio Children's Hospital /ID# 262601

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90240-510, Brazil

  • Seoul National University Hospital /ID# 262324

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 261832

    RECRUITING

    Sheffield, England, S10 2TH, United Kingdom

  • Shengjing Hospital of China Medical University /ID# 262301

    RECRUITING

    Shenyang, Liaoning, 110022, China

  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589

    RECRUITING

    Sofia, 1606, Bulgaria

  • Starship Child Health /ID# 262576

    COMPLETED

    Grafton, Auckland, 1023, New Zealand

  • Sydney Children's Hospital /ID# 262352

    RECRUITING

    Randwick, New South Wales, 2031, Australia

  • The Children's Hospital of Zhejiang University School of Medicine /ID# 262337

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807

    RECRUITING

    Guangzhou, Guangdong, 510655, China

  • Tokyo Metropolitan Children's Medical Center /ID# 262550

    RECRUITING

    Fuchu-shi, Tokyo, 183-8561, Japan

  • Toyama Prefectural Central Hospital /ID# 262739

    RECRUITING

    Toyama, Toyama, 930-8550, Japan

  • Tsujinaka Hospital - Kashiwanoha /ID# 262454

    RECRUITING

    Kashiwa-shi, Chiba, 277-0871, Japan

  • UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750

    RECRUITING

    Namur, 5000, Belgium

  • UCSF Benioff Children's Hospital - Oakland /ID# 262217

    RECRUITING

    Oakland, California, 94609, United States

  • UH Cleveland Medical Center /ID# 262188

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • UMHAT Sveti Georgi /ID# 262590

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Univ NC Chapel Hill /ID# 262198

    RECRUITING

    Chapel Hill, North Carolina, 27514-4220, United States

  • Universitair Ziekenhuis Leuven /ID# 261740

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University General Hospital of Heraklion PA.G.N.I /ID# 261791

    RECRUITING

    Heraklion, Crete, 71500, Greece

  • Uza /Id# 261745

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Yonsei University Health System Severance Hospital /ID# 262721

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

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