Actively Recruiting
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Led by AbbVie · Updated on 2026-05-13
110
Participants Needed
84
Research Sites
538 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weight at Screening and Baseline must be >= 10 kg
- Moderate to severe Crohn's Disease defined as Pediatric Crohn's Disease Activity Index (PCDAI) > 30 and endoscopic evidence of mucosal inflammation with SES-CD >= 6 (or >=4 for isolated ileal disease)
- Confirmed diagnosis of Crohn's Disease before Baseline by colonoscopy during screening, with biopsy results consistent with Crohn's Disease
- Inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, and/or biologic therapy, or medical contraindications to these treatments
- For US and South Korea participants, inadequate response, loss of response, or intolerance to one or more anti-TNFs is required
You will not qualify if you...
- Diagnosis of Crohn's Disease before 2 years of age
- Current complications such as active abscess (abdominal or perianal), symptomatic bowel strictures, more than 2 missing intestinal segments among terminal ileum, right colon, transverse colon, sigmoid, left colon, and rectum
- Presence of ostomy or ileoanal pouch
- Surgical bowel resection within 3 months prior to Baseline, or history of more than 3 bowel resections
- For Japan participants: positive or indeterminate beta-D-glucan test during screening
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic inflammatory bowel disease
- Fulminant colitis or toxic megacolon
- History of gastrointestinal perforation (excluding appendicitis or mechanical injury), diverticulitis, or high risk for GI perforation
- Current diagnosis of any primary immune deficiency
- Conditions interfering with drug absorption such as short bowel syndrome or gastric bypass surgery; history of gastric banding or segmentation is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 84 locations
1
UCSF Benioff Children's Hospital - Oakland /ID# 262217
Oakland, California, United States, 94609
Actively Recruiting
2
Lucile Packard Children's Hospital /ID# 262193
Palo Alto, California, United States, 94304
Actively Recruiting
3
Children's Hospital Colorado - Aurora /ID# 262207
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Connecticut Children's Medical Center - Hartford /ID# 262256
Hartford, Connecticut, United States, 06106
Actively Recruiting
5
OSF St. Francis Medical Center /ID# 262192
Peoria, Illinois, United States, 61637-0001
Actively Recruiting
6
Indiana University Health Riley Hospital for Children /ID# 262215
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Boston Children's Hospital /ID# 262191
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
MNGI Digestive Health, P. A. /ID# 262204
Minneapolis, Minnesota, United States, 55413-2195
Actively Recruiting
9
Icahn School of Medicine at Mount Sinai /ID# 262216
New York, New York, United States, 10029
Actively Recruiting
10
Univ NC Chapel Hill /ID# 262198
Chapel Hill, North Carolina, United States, 27514-4220
Actively Recruiting
11
UH Cleveland Medical Center /ID# 262188
Cleveland, Ohio, United States, 44106
Actively Recruiting
12
Children's Hospital of Philadelphia - Main /ID# 262197
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
13
Sydney Children's Hospital /ID# 262352
Randwick, New South Wales, Australia, 2031
Actively Recruiting
14
Children's Hospital at Westmead /ID# 262350
Westmead, New South Wales, Australia, 2145
Actively Recruiting
15
Queensland Children's Hospital /ID# 262351
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
16
Monash Health - Monash Medical Centre /ID# 262878
Clayton, Victoria, Australia, 3168
Actively Recruiting
17
Perth Children'S Hospital /ID# 272905
Perth, Western Australia, Australia, 6009
Actively Recruiting
18
Uza /Id# 261745
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
19
Cliniques Universitaires UCL Saint-Luc /ID# 261741
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
20
Universitair Ziekenhuis Leuven /ID# 261740
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
21
Hospital Universite Enfants Reine Fabiola /ID# 261744
Brussels, Belgium, 1020
Actively Recruiting
22
CHR de la Citadelle /ID# 261749
Liège, Belgium, 4000
Actively Recruiting
23
UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 261750
Namur, Belgium, 5000
Actively Recruiting
24
Galileo Medical Research Ltda /ID# 262602
Juiz de Fora, Minas Gerais, Brazil, 36033-318
Actively Recruiting
25
Hospital Pequeno Príncipe /ID# 262600
Curitiba, Paraná, Brazil, 80250-060
Actively Recruiting
26
Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 262601
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
27
Rocco & Nazato Servicos Medicos /ID# 262485
São Paulo, São Paulo, Brazil, 04543-011
Actively Recruiting
28
Hospital Sirio Libanes /ID# 262670
São Paulo, Brazil, 01308-050
Actively Recruiting
29
UMHAT Sveti Georgi /ID# 262590
Plovdiv, Bulgaria, 4002
Actively Recruiting
30
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 262589
Sofia, Bulgaria, 1606
Actively Recruiting
31
IWK Health Center /ID# 262543
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
32
CHU Sainte-Justine /ID# 262096
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
33
Beijing Children's Hospital /ID# 262258
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
34
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 262596
Guangzhou, Guangdong, China, 510620
Actively Recruiting
35
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 272807
Guangzhou, Guangdong, China, 510655
Actively Recruiting
36
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 262300
Zhengzhou, Henan, China, 450018
Actively Recruiting
37
Hunan Children's Hospital /ID# 262512
Changsha, Hunan, China, 410007
Actively Recruiting
38
Jiangxi Provincial Children's Hospital /ID# 262295
Nanchang, Jiangxi, China, 330006
Actively Recruiting
39
Shengjing Hospital of China Medical University /ID# 262301
Shenyang, Liaoning, China, 110022
Actively Recruiting
40
Children's Hospital of Shanghai /ID# 262356
Shanghai, Shanghai Municipality, China, 200062
Actively Recruiting
41
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 262502
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
42
The Children's Hospital of Zhejiang University School of Medicine /ID# 262337
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
43
CHU de CAEN - Hopital de la Cote de Nacre /ID# 262311
Caen, Calvados, France, 14033
Actively Recruiting
44
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 263422
Bron, Rhone, France, 69500
Actively Recruiting
45
Hopitaux de Paris (AP-HP) - Hopital Robert Debre - CHU /ID# 262308
Paris, France, 75019
Actively Recruiting
46
Agia Sofia Hospital /ID# 261792
Athens, Attica, Greece, 11527
Actively Recruiting
47
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 261790
Athens, Attica, Greece, 11527
Actively Recruiting
48
University General Hospital of Heraklion PA.G.N.I /ID# 261791
Heraklion, Crete, Greece, 71500
Actively Recruiting
49
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 262384
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
50
Ospedale Pediatrico Bambino Gesù /ID# 262379
Rome, Roma, Italy, 00165
Actively Recruiting
51
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 262380
Messina, Italy, 98125
Actively Recruiting
52
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 275276
Milan, Italy, 20122
Actively Recruiting
53
Tsujinaka Hospital - Kashiwanoha /ID# 262454
Kashiwa-shi, Chiba, Japan, 277-0871
Actively Recruiting
54
Kurume University Hospital /ID# 262455
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
55
Miyagi Children's Hospital /ID# 262459
Sendai, Miyagi, Japan, 989-3126
Actively Recruiting
56
Osaka Women's and Children's Hospital /ID# 262549
Izumi-Shi, Osaka, Japan, 594-1101
Actively Recruiting
57
Saga University Hospital /ID# 262753
Saga, Saga-ken, Japan, 849-8501
Actively Recruiting
58
Saitama Children's Medical Center /ID# 262461
Saitama-shi, Saitama, Japan, 330-8777
Actively Recruiting
59
Institute of Science Tokyo Hospital /ID# 262510
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
60
Tokyo Metropolitan Children's Medical Center /ID# 262550
Fuchu-shi, Tokyo, Japan, 183-8561
Actively Recruiting
61
National Center For Child Health And Development /ID# 262456
Setagaya City, Tokyo, Japan, 157-8535
Actively Recruiting
62
Toyama Prefectural Central Hospital /ID# 262739
Toyama, Toyama, Japan, 930-8550
Actively Recruiting
63
Christchurch Hospital. /ID# 262577
Christchurch, Canterbury, New Zealand, 8011
Actively Recruiting
64
Starship Child Health /ID# 262576
Auckland, New Zealand, 0629
Completed
65
Gastromed Sp. z o.o /ID# 262367
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
66
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 262366
Warsaw, Masovian Voivodeship, Poland, 04-730
Actively Recruiting
67
Clinical Research Investigator Group /ID# 262357
Bayamón, Puerto Rico, 00960
Actively Recruiting
68
Puerto Rico Health Institute /ID# 262358
Dorado, Puerto Rico, 00646
Actively Recruiting
69
Clinical Research Puerto Rico /ID# 279595
San Juan, Puerto Rico, 00909-1711
Actively Recruiting
70
Seoul National University Hospital /ID# 262324
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
71
Yonsei University Health System Severance Hospital /ID# 262721
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
72
Samsung Medical Center /ID# 262323
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
73
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 262226
Ferrol, A Coruna, Spain, 15405
Actively Recruiting
74
Hospital Sant Joan de Deu /ID# 262599
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
75
Hospital Regional Universitario de Malaga /ID# 262228
Málaga, Spain, 29011
Actively Recruiting
76
Hospital Universitario Virgen del Rocio /ID# 262712
Seville, Spain, 41013
Actively Recruiting
77
Hospital Clinico Universitario Lozano Blesa /ID# 262227
Zaragoza, Spain, 50009
Completed
78
National Taiwan University Hospital /ID# 261695
Taipei City, Taipei, Taiwan, 100
Actively Recruiting
79
Linkou Chang Gung Memorial Hospital /ID# 261696
Taoyuan City, Taiwan, 333
Actively Recruiting
80
Addenbrookes Hospital /ID# 262707
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
81
Sheffield Children's Hospital NHS Foundation Trust /ID# 261832
Sheffield, England, United Kingdom, S10 2TH
Actively Recruiting
82
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 262811
London, Greater London, United Kingdom, E1 2ES
Actively Recruiting
83
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 262778
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
84
Royal Hospital for Children and Young People /ID# 262388
Edinburgh, United Kingdom, EH16 4TJ
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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