Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Last updated: April 14, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Ulcers

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

Upadacitinib

Clinical Study ID

NCT05782907
M14-658
2022-501788-41-00
  • Ages 2-17
  • All Genders

Study Summary

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.

Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active UC with an AMS of 5 to 9 points and endoscopic subscore of 2 to 3.

  • Demonstrate an inadequate response, loss of response, intolerance, or medicalcontraindications to corticosteroids, immunosuppressants, and/or biologic therapy.

Exclusion

Exclusion Criteria:

  • Partcipants with previous exposure to JAK inhibitors (e.g., tofacitinib,baricitinib, filgotinib, upadacitinib).

  • Females who are pregnant, breastfeeding, or considering becoming pregnant during thestudy and for approximately 30 days after the last dose of study drug.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Upadacitinib
Phase: 3
Study Start date:
November 06, 2023
Estimated Completion Date:
October 31, 2033

Connect with a study center

  • Hospital Italiano de Buenos Aires /ID# 251796

    Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires 1199
    Argentina

    Site Not Available

  • Hospital Privado Univesitario /ID# 251902

    Cordoba, 5016
    Argentina

    Site Not Available

  • Children's Hospital at Westmead /ID# 255556

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Queensland Children's Hospital /ID# 261032

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre /ID# 254726

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 254726

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Perth Children's Hospital /ID# 254727

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perth Children'S Hospital /ID# 254727

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen /ID# 251184

    Edegem, Antwerpen 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven /ID# 251185

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Hospital Pequeno Princípe /ID# 251911

    Curitiba, Parana 80250-060
    Brazil

    Site Not Available

  • Hospital Pequeno Príncipe /ID# 251911

    Curitiba, Parana 80250-060
    Brazil

    Active - Recruiting

  • Hospital PUC-Campinas /ID# 251912

    Campinas, Sao Paulo 13060-904
    Brazil

    Site Not Available

  • Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 251912

    Campinas, Sao Paulo 13034-685
    Brazil

    Active - Recruiting

  • Rocco & Nazato Servicos Medicos /ID# 251910

    São Paulo, Sao Paulo 04543-011
    Brazil

    Active - Recruiting

  • Rocco e Nazato Serviços Médicos Ltda. /ID# 251910

    Sao Paulo, 04543-001
    Brazil

    Site Not Available

  • UMHAT Sveti Georgi /ID# 251949

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 251287

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251285

    Sofiya, 1606
    Bulgaria

    Active - Recruiting

  • Duplicate_UMHAT Sveta Marina /ID# 251948

    Varna, 9010
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Sveta Marina /ID# 251948

    Varna, 9009
    Bulgaria

    Active - Recruiting

  • UMHAT Sveta Marina /ID# 251948

    Varna, 9010
    Bulgaria

    Active - Recruiting

  • Alberta Health Services /ID# 252088

    Edmonton, Alberta T6G 1C9
    Canada

    Active - Recruiting

  • BC Children's Hospital /ID# 250947

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • IWK Health Center /ID# 250943

    Halifax, Nova Scotia B3K 6R8
    Canada

    Active - Recruiting

  • Hospital for Sick Children /ID# 250945

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Fakultní Nemocnice Plzeň-Lochotín /ID# 253284

    Pilsen, Plzen-jih 323 00
    Czechia

    Active - Recruiting

  • Fakultní nemocnice v Motole /ID# 251955

    Prague, Praha 5 150 06
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Plzen /ID# 253284

    Plzen, 305 99
    Czechia

    Site Not Available

  • Fakultni Nemocnice v Motole /ID# 251955

    Praha, 150 06
    Czechia

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 253182

    Bordeaux CEDEX, Gironde 33076
    France

    Site Not Available

  • CHU Bordeaux - Hopital Pellegrin /ID# 253182

    Bordeaux, Nouvelle-Aquitaine 33076
    France

    Active - Recruiting

  • HCL - Hopital Femme Mere Enfant /ID# 251502

    Bron CEDEX, Rhone 69677
    France

    Active - Recruiting

  • HCL - Hopital Lyon Sud /ID# 251502

    Bron CEDEX, Rhone 69677
    France

    Site Not Available

  • AP-HP - Hopital Necker /ID# 251658

    Paris, 75015
    France

    Active - Recruiting

  • Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 252069

    Paris, 75019
    France

    Active - Recruiting

  • Robert Debre Hopital, FR /ID# 252069

    Paris, 75019
    France

    Active - Recruiting

  • CHU Toulouse - Hopital Paule de Viguier /ID# 252070

    Toulouse, 31059
    France

    Active - Recruiting

  • Dr. von Haunerschen Kinderspital /ID# 251440

    Muenchen, Bayern 80337
    Germany

    Active - Recruiting

  • Universitaetsklinikum Muenster /ID# 256763

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Active - Recruiting

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 251434

    Berlin, 13353
    Germany

    Active - Recruiting

  • Dr. Haunerschen Kinderspital /ID# 251440

    Munich, 80337
    Germany

    Site Not Available

  • Agia Sofia Hospital /ID# 250697

    Athens, Attiki 11527
    Greece

    Active - Recruiting

  • University General Hospital of Heraklion PA.G.N.I /ID# 250696

    Heraklion, Kriti 71500
    Greece

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont /ID# 251835

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

  • Debreceni Egyetem-Klinikai Kozpont /ID# 251835

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem /ID# 251083

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Schneider Children's Medical Center /ID# 254833

    Petah Tikva, HaMerkaz 4920235
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center /ID# 254832

    Jerusalem, Yerushalayim 91031
    Israel

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer /ID# 251624

    Florence, Firenze 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 251625

    Rome, Roma 00161
    Italy

    Active - Recruiting

  • Sapienza University /ID# 251625

    Rome, Roma 00161
    Italy

    Site Not Available

  • Ospedale Maggiore Carlo Alberto Pizzardi /ID# 251626

    Bologna, 40133
    Italy

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha /ID# 251930

    Kashiwa-shi, Chiba 277-0871
    Japan

    Active - Recruiting

  • Kurume University Hospital /ID# 251927

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 251928

    Sapporo-shi, Hokkaido 060-0033
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital /ID# 251931

    Sendai-shi, Miyagi 989-3126
    Japan

    Active - Recruiting

  • Osaka Women's and Children's Hospital /ID# 252397

    Izumi-Shi, Osaka 594-1101
    Japan

    Active - Recruiting

  • Osaka General Medical Center /ID# 253678

    Osaka-shi, Osaka 558-8558
    Japan

    Active - Recruiting

  • Saitama Children's Medical Center /ID# 252362

    Saitama-shi, Saitama 330-8777
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital /ID# 251929

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Hospital /ID# 251929

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Children's Medical Center /ID# 252477

    Fuchu City, Tokyo 183-8524
    Japan

    Site Not Available

  • Tokyo Metropolitan Children's Medical Center /ID# 252477

    Fuchu-shi, Tokyo 183-8561
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Children's Medical Center /ID# 252477

    Fucyu-shi, Tokyo 183-8561
    Japan

    Site Not Available

  • National Center for Child Health and Development /ID# 251926

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Tokyo Metropolitan Children's Medical Center /ID# 252477

    府中市, Tokyo 〒183-8524
    Japan

    Site Not Available

  • Saitama Children's Medical Center - Shintoshin /ID# 252362

    Saitama, 330-8777
    Japan

    Site Not Available

  • Samsung Medical Center /ID# 252023

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 252024

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital /ID# 252663

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • Panamerican Clinical Research Mexico S.A de C.V /ID# 252229

    Cuernavaca, Morelos 62290
    Mexico

    Site Not Available

  • Servicios de Oncologia Medica Integral SA de CV /ID# 252974

    San Pedro Garza Garcia, Nuevo Leon 66220
    Mexico

    Active - Recruiting

  • Amsterdam UMC, locatie AMC /ID# 250845

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Academisch Medisch Centrum /ID# 250845

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Groningen /ID# 252003

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Starship Child Health /ID# 254702

    Grafton, Auckland 1023
    New Zealand

    Site Not Available

  • Christchurch Hospital /ID# 254703

    Christchurch, Canterbury 8011
    New Zealand

    Active - Recruiting

  • Starship Child Health /ID# 254702

    Auckland, 0629
    New Zealand

    Active - Recruiting

  • Gastromed /Id# 251290

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • Gastromed Sp. z o.o /ID# 251290

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 251387

    Krakow, Malopolskie 30-663
    Poland

    Site Not Available

  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 251289

    Warszawa, Mazowieckie 04-730
    Poland

    Active - Recruiting

  • Clinical Research Puerto Rico /ID# 266477

    San Juan, 00909-1711
    Puerto Rico

    Active - Recruiting

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 252105

    Ferrol, A Coruna 15405
    Spain

    Active - Recruiting

  • Hospital Sant Joan de Deu /ID# 251194

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron /ID# 252104

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga /ID# 251193

    Malaga, 29011
    Spain

    Active - Recruiting

  • National Taiwan University Hospital /ID# 251650

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 251654

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Ankara Universitesi Fakultesi /ID# 252487

    Ankara, 06620
    Turkey

    Site Not Available

  • Gazi University Medical Faculty /ID# 251768

    Ankara, 06560
    Turkey

    Site Not Available

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 252002

    Istanbul, 34098
    Turkey

    Site Not Available

  • Sheffield Children's Hospital NHS Foundation Trust /ID# 251600

    Sheffield, England S10 2TH
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust /ID# 251917

    London, Greater London E1 2ES
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Children's Hospital /ID# 252126

    London, Greater London WC1N 3HZ
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust /ID# 252097

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children /ID# 252126

    London, London, City Of WC1N 3JH
    United Kingdom

    Site Not Available

  • Birmingham Women's and Children's NHS Foundation Trust /ID# 253072

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital /ID# 251600

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's NHS Foundation Trust /ID# 251600

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Phoenix Children's Hospital /ID# 250135

    Phoenix, Arizona 85016-7710
    United States

    Active - Recruiting

  • Arkansas Children's Hospital /ID# 250106

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Kindred Medical Institute - Corona /ID# 255484

    Corona, California 92879-3104
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital - Oakland /ID# 255067

    Oakland, California 94609
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital Oakland /ID# 255067

    Oakland, California 94609-1809
    United States

    Active - Recruiting

  • Children's Hospital Colorado - Aurora /ID# 250110

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's Hospital Colorado /ID# 250110

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Nemours/Alfred duPont Hospital for Children /ID# 255483

    Wilmington, Delaware 19803
    United States

    Completed

  • Childrens Healthcare of Atlanta - Center for Advanced Pediatrics /ID# 255069

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • OSF St. Francis Medical Center /ID# 256968

    Peoria, Illinois 61637-0001
    United States

    Active - Recruiting

  • Boston Children's Hospital /ID# 250108

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital /ID# 250142

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island /ID# 250136

    Mineola, New York 11501
    United States

    Active - Recruiting

  • NYU Langone Hospital-Long Island /ID# 250136

    Mineola, New York 11501
    United States

    Site Not Available

  • The Mount Sinai Hospital /ID# 250141

    New York, New York 10029
    United States

    Active - Recruiting

  • Univ NC Chapel Hill /ID# 254541

    Chapel Hill, North Carolina 27514-4220
    United States

    Active - Recruiting

  • Levine Children's Hospital /ID# 250131

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Levine Children's Specialty Center- Charlotte /ID# 250131

    Charlotte, North Carolina 28203-5866
    United States

    Active - Recruiting

  • UH Cleveland Medical Center /ID# 250134

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia - Main /ID# 258773

    Philadelphia, Pennsylvania 19104-4319
    United States

    Active - Recruiting

  • Children's Hospital of Pittsburgh of UPMC /ID# 250118

    Pittsburgh, Pennsylvania 15224-1334
    United States

    Site Not Available

  • Children's Specialty Group /ID# 256966

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • University of Wisconsin - Madison /ID# 250632

    Madison, Wisconsin 53715-1218
    United States

    Active - Recruiting

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