Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Start Date
8/8/2024
Completion Date
12/1/2034
Summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-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 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 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 have a safety follow up for 30 days after discontinuation from any time point within the study. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) 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
Age Range: 2 years to 17 years
Interventions
Upadacitinib
Conditions
Locations
UCSF Benioff Children's Hospital - Oakland /ID# 262217
Oakland, California 94609
United States
Lucile Packard Children's Hospital /ID# 262193
Palo Alto, California 94304
United States
Children's Hospital Colorado - Aurora /ID# 262207
Aurora, Colorado 80045
United States
Connecticut Children's Medical Center - Hartford /ID# 262256
Hartford, Connecticut 06106
United States
OSF St. Francis Medical Center /ID# 262192
Peoria, Illinois 61637-0001
United States
Indiana University Health Riley Hospital for Children /ID# 262215
Indianapolis, Indiana 46202
United States
Boston Children's Hospital /ID# 262191
Boston, Massachusetts 02115
United States
MNGI Digestive Health, P. A. /ID# 262204
Minneapolis, Minnesota 55413-2195
United States
Icahn School of Medicine at Mount Sinai /ID# 262216
New York, New York 10029
United States
Univ NC Chapel Hill /ID# 262198
Chapel Hill, North Carolina 27514-4220
United States
UH Cleveland Medical Center /ID# 262188
Cleveland, Ohio 44106
United States
Children's Hospital of Philadelphia - Main /ID# 262197
Philadelphia, Pennsylvania 19104-4319
United States
Sydney Children's Hospital /ID# 262352
Randwick, New South Wales 2031
Australia
Children's Hospital at Westmead /ID# 262350
Westmead, New South Wales 2145
Australia
Queensland Children's Hospital /ID# 262351
South Brisbane, Queensland 4101
Australia
Monash Health - Monash Medical Centre - Clayton /ID# 262878
Clayton, Victoria 3168
Australia
Perth Children'S Hospital /ID# 272905
Perth, Western Australia 6009
Australia
Uza /Id# 261745
Edegem, Antwerpen 2650
Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 261741
Brussels, Brussels Capital 1200
Belgium
Universitair Ziekenhuis Leuven /ID# 261740
Leuven, Vlaams-Brabant 3000
Belgium
Hospital Universite Enfants Reine Fabiola /ID# 261744
Brussels, 1020
Belgium
CHR de la Citadelle /ID# 261749
Liège, 4000
Belgium
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750
Namur, 5000
Belgium
Galileo Medical Research Ltda /ID# 262602
Juiz de Fora, Minas Gerais 36033-318
Brazil
Hospital Pequeno Príncipe /ID# 262600
Curitiba, Paraná 80250-060
Brazil
Santo Antônio Children's Hospital /ID# 262601
Porto Alegre, Rio Grande do Sul 90240-510
Brazil
Rocco & Nazato Servicos Medicos /ID# 262485
São Paulo, São Paulo 04543-011
Brazil
Hospital Sirio Libanes - Sao Paulo /ID# 262670
São Paulo, 01308-050
Brazil
UMHAT Sveti Georgi /ID# 262590
Plovdiv, 4002
Bulgaria
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589
Sofia, 1606
Bulgaria
BC Children's Hospital /ID# 262237
Vancouver, British Columbia V6H 3V4
Canada
IWK Health Center /ID# 262543
Halifax, Nova Scotia B3K 6R8
Canada
CHU Sainte-Justine /ID# 262096
Montreal, Quebec H3T 1C5
Canada
Beijing Children's Hospital /ID# 262258
Beijing, Beijing Municipality 100045
China
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596
Guangzhou, Guangdong 510620
China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807
Guangzhou, Guangdong 510655
China
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300
Zhengzhou, Henan 450018
China
Hunan Children's Hospital /ID# 262512
Changsha, Hunan 410007
China
Jiangxi Provincial Children's Hospital /ID# 262295
Nanchang, Jiangxi 330006
China
Shengjing Hospital of China Medical University /ID# 262301
Shenyang, Liaoning 110022
China
Children's Hospital of Shanghai /ID# 262356
Shanghai, Shanghai Municipality 200062
China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502
Shanghai, Shanghai Municipality 200065
China
The Children's Hospital of Zhejiang University School of Medicine /ID# 262337
Hangzhou, Zhejiang 310003
China
CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311
Caen, Calvados 14033
France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 263422
Bron, Rhone 69500
France
Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308
Paris, 75019
France
Agia Sofia Hospital /ID# 261792
Athens, Attica 11527
Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790
Athens, Attica 11527
Greece
University General Hospital of Heraklion PA.G.N.I /ID# 261791
Heraklion, Crete 71500
Greece
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384
San Giovanni Rotondo, Foggia 71013
Italy
Ospedale Pediatrico Bambino Gesù /ID# 262379
Rome, Roma 00165
Italy
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380
Messina, 98125
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 275276
Milan, 20122
Italy
Tsujinaka Hospital - Kashiwanoha /ID# 262454
Kashiwa-shi, Chiba 277-0871
Japan
Kurume University Hospital /ID# 262455
Kurume-shi, Fukuoka 830-0011
Japan
Miyagi Children's Hospital /ID# 262459
Sendai, Miyagi 989-3126
Japan
Osaka Women's and Children's Hospital /ID# 262549
Izumi-Shi, Osaka 594-1101
Japan
Saga University Hospital /ID# 262753
Saga, Saga-ken 849-8501
Japan
Saitama Children's Medical Center /ID# 262461
Saitama-shi, Saitama 330-8777
Japan
Institute of Science Tokyo Hospital /ID# 262510
Bunkyo-ku, Tokyo 113-8519
Japan
Tokyo Metropolitan Children's Medical Center /ID# 262550
Fuchu-shi, Tokyo 183-8561
Japan
National Center For Child Health And Development /ID# 262456
Setagaya City, Tokyo 157-8535
Japan
Toyama Prefectural Central Hospital /ID# 262739
Toyama, Toyama 930-8550
Japan
Starship Child Health /ID# 262576
Grafton, Auckland 1023
New Zealand
Christchurch Hospital. /ID# 262577
Christchurch, Canterbury 8011
New Zealand
Gastromed Sp. z o.o /ID# 262367
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366
Warsaw, Masovian Voivodeship 04-730
Poland
Clinical Research Investigator Group /ID# 262357
Bayamón, 00960
Puerto Rico
Puerto Rico Health Institute /ID# 262358
Dorado, 00646
Puerto Rico
Clinical Research Puerto Rico /ID# 279595
San Juan, 00909-1711
Puerto Rico
Seoul National University Hospital /ID# 262324
Seoul, Seoul Teugbyeolsi 03080
South Korea
Yonsei University Health System Severance Hospital /ID# 262721
Seoul, Seoul Teugbyeolsi 03722
South Korea
Samsung Medical Center /ID# 262323
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226
Ferrol, A Coruna 15405
Spain
Hospital Sant Joan de Deu /ID# 262599
Esplugues de Llobregat, Barcelona 08950
Spain
Hospital Regional Universitario de Malaga /ID# 262228
Málaga, 29011
Spain
Hospital Universitario Virgen del Rocio /ID# 262712
Seville, 41013
Spain
Hospital Clinico Universitario Lozano Blesa /ID# 262227
Zaragoza, 50009
Spain
National Taiwan University Hospital /ID# 261695
Taipei, 100
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 261696
Taoyuan City, 333
Taiwan
Addenbrookes Hospital /ID# 262707
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
Sheffield, England S10 2TH
United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
London, Greater London E1 2ES
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
Norwich, Norfolk NR4 7UY
United Kingdom
Royal Hospital for Children and Young People /ID# 262388
Edinburgh, EH16 4TJ
United Kingdom