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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.
Sponsor: AbbVie
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.
Official title: A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2023-11-06
Completion Date
2033-10
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Oral Solution/ Tablets
Locations (89)
Phoenix Children's Hospital /ID# 250135
Phoenix, Arizona, United States
Arkansas Children's Hospital /ID# 250106
Little Rock, Arkansas, United States
Kindred Medical Institute - Corona /ID# 255484
Corona, California, United States
UCSF Benioff Children's Hospital - Oakland /ID# 255067
Oakland, California, United States
Lucile Packard Children's Hospital /ID# 258430
Palo Alto, California, United States
Children's Hospital Colorado - Aurora /ID# 250110
Aurora, Colorado, United States
Nemours/Alfred duPont Hospital for Children /ID# 255483
Wilmington, Delaware, United States
Childrens Healthcare of Atlanta - Center for Advanced Pediatrics /ID# 255069
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 254505
Chicago, Illinois, United States
OSF St. Francis Medical Center /ID# 256968
Peoria, Illinois, United States
Massachusetts General Hospital /ID# 250142
Boston, Massachusetts, United States
Boston Children's Hospital /ID# 250108
Boston, Massachusetts, United States
NYU Langone Hospital - Long Island /ID# 250136
Mineola, New York, United States
The Mount Sinai Hospital /ID# 250141
New York, New York, United States
Univ NC Chapel Hill /ID# 254541
Chapel Hill, North Carolina, United States
Levine Children's Hospital /ID# 250131
Charlotte, North Carolina, United States
UH Cleveland Medical Center /ID# 250134
Cleveland, Ohio, United States
Children's Hospital of Philadelphia - Main /ID# 258773
Philadelphia, Pennsylvania, United States
Children's Specialty Group /ID# 256966
Norfolk, Virginia, United States
University of Wisconsin - Madison /ID# 250632
Madison, Wisconsin, United States
Children's Hospital at Westmead /ID# 255556
Westmead, New South Wales, Australia
Queensland Children's Hospital /ID# 261032
South Brisbane, Queensland, Australia
Monash Health - Monash Medical Centre /ID# 254726
Clayton, Victoria, Australia
Perth Children'S Hospital /ID# 254727
Perth, Western Australia, Australia
Universitair Ziekenhuis Antwerpen /ID# 251184
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Leuven /ID# 251185
Leuven, Vlaams-Brabant, Belgium
Hospital Pequeno Príncipe /ID# 251911
Curitiba, Paraná, Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas /ID# 251912
Campinas, São Paulo, Brazil
Rocco & Nazato Servicos Medicos /ID# 251910
São Paulo, São Paulo, Brazil
UMHAT Sveti Georgi /ID# 251949
Plovdiv, Bulgaria
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 251285
Sofia, Bulgaria
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 251948
Varna, Bulgaria
Alberta Health Services /ID# 252088
Edmonton, Alberta, Canada
South Edmonton Gastroenterology /ID# 276669
Edmonton, Alberta, Canada
BC Children's Hospital /ID# 250947
Vancouver, British Columbia, Canada
IWK Health Center /ID# 250943
Halifax, Nova Scotia, Canada
Hospital for Sick Children /ID# 250945
Toronto, Ontario, Canada
Fakultní Nemocnice Plzeň-Lochotín /ID# 253284
Pilsen, Plzen-jih, Czechia
Fakultní nemocnice v Motole /ID# 251955
Prague, Praha 5, Czechia
CHU Bordeaux - Hopital Pellegrin /ID# 253182
Bordeaux, Nouvelle-Aquitaine, France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 251502
Bron, Rhone, France
AP-HP - Hopital Necker /ID# 251658
Paris, France
Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 252069
Paris, France
CHU Toulouse - Hopital Paule de Viguier /ID# 252070
Toulouse, France
Dr. von Haunerschen Kinderspital /ID# 251440
Munich, Bavaria, Germany
Universitaetsklinikum Muenster /ID# 256763
Münster, North Rhine-Westphalia, Germany
Klinikum St. Georg gGmbH /ID# 262481
Leipzig, Saxony, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 251434
Berlin, Germany
Agia Sofia Hospital /ID# 250697
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 250696
Heraklion, Crete, Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 251835
Debrecen, Hajdú-Bihar, Hungary
Semmelweis Egyetem /ID# 251083
Budapest, Hungary
Schneider Children's Medical Center /ID# 254833
Petah Tikva, Central District, Israel
Shaare Zedek Medical Center /ID# 254832
Jerusalem, Jerusalem, Israel
Azienda Ospedaliero Universitaria Meyer /ID# 251624
Florence, Firenze, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 251625
Rome, Roma, Italy
Ospedale Maggiore Carlo Alberto Pizzardi /ID# 251626
Bologna, Italy
Tsujinaka Hospital - Kashiwanoha /ID# 251930
Kashiwa-shi, Chiba, Japan
Kurume University Hospital /ID# 251927
Kurume-shi, Fukuoka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 251928
Sapporo, Hokkaido, Japan
Miyagi Children's Hospital /ID# 251931
Sendai, Miyagi, Japan
Osaka Women's and Children's Hospital /ID# 252397
Izumi-Shi, Osaka, Japan
Osaka General Medical Center /ID# 253678
Osaka, Osaka, Japan
Saitama Children's Medical Center /ID# 252362
Saitama-shi, Saitama, Japan
Institute of Science Tokyo Hospital /ID# 251929
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Children's Medical Center /ID# 252477
Fuchu-shi, Tokyo, Japan
National Center For Child Health And Development /ID# 251926
Setagaya City, Tokyo, Japan
Servicios de Oncologia Medica Integral SA de CV /ID# 252974
San Pedro Garza García, Nuevo León, Mexico
Amsterdam UMC, locatie AMC /ID# 250845
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 252003
Groningen, Netherlands
Christchurch Hospital. /ID# 254703
Christchurch, Canterbury, New Zealand
Starship Child Health /ID# 254702
Auckland, New Zealand
Gastromed Sp. z o.o /ID# 251290
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 251289
Warsaw, Masovian Voivodeship, Poland
Clinical Research Puerto Rico /ID# 266477
San Juan, Puerto Rico
Seoul National University Hospital /ID# 252024
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 252023
Seoul, Seoul Teugbyeolsi, South Korea
Kyungpook National University Chilgok Hospital /ID# 252663
Daegu, South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 252105
Ferrol, A Coruna, Spain
Hospital Sant Joan de Deu /ID# 251194
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Vall de Hebron /ID# 252104
Barcelona, Spain
Hospital Regional Universitario de Malaga /ID# 251193
Málaga, Spain
National Taiwan University Hospital /ID# 251650
Taipei City, Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 251654
Taoyuan, Taiwan
Sheffield Children's Hospital NHS Foundation Trust /ID# 251600
Sheffield, England, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 251917
London, Greater London, United Kingdom
Great Ormond Street Children's Hospital /ID# 252126
London, Greater London, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 252097
Southampton, Hampshire, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust /ID# 253072
Birmingham, United Kingdom