Actively Recruiting
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Led by AbbVie · Updated on 2026-05-13
110
Participants Needed
85
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. 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.
CONDITIONS
Official Title
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric individuals aged 2 to less than 18 years
- Moderately to severely active Crohn's Disease with PCDAI score over 30 at baseline
- Endoscopic evidence of mucosal inflammation with SES-CD score ≥6 for ileocolonic or colonic disease, or SES-CD ≥4 for isolated ileal disease
- Intolerance or inadequate response to one or more drugs including aminosalicylates (except in France, Italy, Netherlands, Spain, Sweden), oral corticosteroids, systemic steroids, immunomodulators, or biologics
You will not qualify if you...
- History of hereditary fructose intolerance or allergy to risankizumab or similar drugs
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic inflammatory bowel disease
- Crohn's Disease diagnosed before age 2
- Diagnosis or suspected primary immunodeficiency
- Known complications of Crohn's Disease including active abscess, symptomatic bowel strictures, more than 2 missing bowel segments, fulminant colitis, toxic megacolon, or conditions requiring surgery during study
- Presence of ostomy or ileoanal pouch
- Diagnosis of short gut or short bowel syndrome
- Bowel resection surgery within 3 months before baseline or more than 3 prior bowel resections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 85 locations
1
Phoenix Children's Hospital /ID# 255766
Phoenix, Arizona, United States, 85016-7710
Actively Recruiting
2
Arkansas Children's Hospital /ID# 255762
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
UCSF Benioff Children's Hospital - Oakland /ID# 258327
Oakland, California, United States, 94609
Actively Recruiting
4
Children's Hospital Colorado - Aurora /ID# 255764
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Arnold Palmer Hospital for Children Center Digestive Health & Nutrition - Orland /ID# 255437
Orlando, Florida, United States, 32806-1141
Actively Recruiting
6
Indiana University Health Riley Hospital for Children /ID# 256454
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Massachusetts General Hospital /ID# 255767
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
MNGI Digestive Health, P. A. /ID# 255366
Minneapolis, Minnesota, United States, 55413-2195
Actively Recruiting
9
Goryeb Childrens Hospital /ID# 256452
Morristown, New Jersey, United States, 07960
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai /ID# 254880
New York, New York, United States, 10029
Actively Recruiting
11
Cleveland Clinic - Cleveland /ID# 256453
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Uza /Id# 255114
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
13
Cliniques Universitaires UCL Saint-Luc /ID# 255108
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
14
Universitair Ziekenhuis Brussel /ID# 255109
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
15
Groupe Sante CHC - Clinique du MontLegia /ID# 255620
Liège, Liege, Belgium, 4000
Actively Recruiting
16
Universitair Ziekenhuis Leuven /ID# 255098
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
17
Hospital Universite Enfants Reine Fabiola /ID# 255112
Brussels, Belgium, 1020
Actively Recruiting
18
UMHAT Sveti Georgi /ID# 255386
Plovdiv, Bulgaria, 4002
Actively Recruiting
19
Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
Sofia, Bulgaria, 1606
Actively Recruiting
20
UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358
Varna, Bulgaria, 9009
Actively Recruiting
21
Alberta Children's Hospital /ID# 255357
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
22
Edmonton Clinic Health Academy /ID# 255361
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
23
BC Children's Hospital /ID# 255359
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
24
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598
London, Ontario, Canada, N6A 5W9
Actively Recruiting
25
Beijing Children's Hospital /ID# 256081
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
26
Peking University Third Hospital /ID# 255876
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
27
Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428
Guangzhou, Guangdong, China, 510620
Actively Recruiting
28
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589
Guangzhou, Guangdong, China, 510655
Actively Recruiting
29
Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562
Zhengzhou, Henan, China, 450018
Actively Recruiting
30
Hunan Children's Hospital /ID# 255610
Changsha, Hunan, China, 410007
Actively Recruiting
31
Jiangxi Provincial Children's Hospital /ID# 255564
Nanchang, Jiangxi, China, 330006
Actively Recruiting
32
Shengjing Hospital of China Medical University /ID# 255563
Shenyang, Liaoning, China, 110022
Actively Recruiting
33
Children's Hospital of Shanghai /ID# 255531
Shanghai, Shanghai Municipality, China, 200062
Actively Recruiting
34
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
35
Vseobecna Fakultni nemocnice v Praze /ID# 256096
Prague, Praha 17, Czechia, 128 00
Completed
36
Fakultni nemocnice Motol a Homolka /ID# 256547
Prague, Praha 5, Czechia, 150 06
Completed
37
CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
Tours, Centre-Val de Loire, France, 37044
Actively Recruiting
38
CHU Bordeaux - Hopital Pellegrin /ID# 257060
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
39
Hospices Civils de Lyon - Hôpital Femme Mère Enfant /ID# 255443
Bron, Rhone, France, 69500
Actively Recruiting
40
AP-HP - Hopital Necker /ID# 255608
Paris, France, 75015
Actively Recruiting
41
CHU Toulouse - Hopital Paule de Viguier /ID# 255609
Toulouse, France, 31059
Actively Recruiting
42
Dr. von Haunerschen Kinderspital /ID# 255577
Munich, Bavaria, Germany, 80337
Actively Recruiting
43
Universitaetsklinikum Muenster /ID# 256762
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
44
Schneider Children's Medical Center /ID# 254950
Petah Tikva, Central District, Israel, 4920235
Actively Recruiting
45
Shaare Zedek Medical Center /ID# 254951
Jerusalem, Jerusalem, Israel, 91031
Actively Recruiting
46
IRCCS Istituto Giannina Gaslini /ID# 255262
Genoa, Genova, Italy, 16147
Actively Recruiting
47
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045
Naples, Napoli, Italy, 80131
Actively Recruiting
48
Ospedale Pediatrico Bambino Gesù /ID# 255043
Rome, Roma, Italy, 00165
Actively Recruiting
49
Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
Messina, Italy, 98125
Actively Recruiting
50
Aichi Children'S Health And Medical Center /ID# 272085
Ōbu, Aichi-ken, Japan, 474-8710
Actively Recruiting
51
Tsujinaka Hospital - Kashiwanoha /ID# 268409
Kashiwa-shi, Chiba, Japan, 277-0871
Actively Recruiting
52
Kurume University Hospital /ID# 268418
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
53
Gunma University Hospital /ID# 270560
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
54
Japanese Red Cross Kumamoto Hospital /ID# 268586
Kumamoto, Kumamoto, Japan, 861-8520
Actively Recruiting
55
Osaka Women's and Children's Hospital /ID# 268419
Izumi-Shi, Osaka, Japan, 594-1101
Actively Recruiting
56
Saitama Children's Medical Center /ID# 268410
Saitama-shi, Saitama, Japan, 330-8777
Actively Recruiting
57
Institute of Science Tokyo Hospital /ID# 269175
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
58
Tokyo Metropolitan Children's Medical Center /ID# 268415
Fuchu-shi, Tokyo, Japan, 183-8561
Actively Recruiting
59
National Center For Child Health And Development /ID# 268420
Setagaya City, Tokyo, Japan, 157-8535
Actively Recruiting
60
Amsterdam UMC, locatie AMC /ID# 254827
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
61
Gastromed Sp. z o.o /ID# 255939
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Completed
62
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
Warsaw, Masovian Voivodeship, Poland, 04-730
Actively Recruiting
63
Puerto Rico Health Institute /ID# 255071
Dorado, Puerto Rico, 00646
Actively Recruiting
64
Clinical Research Puerto Rico /ID# 266479
San Juan, Puerto Rico, 00909-1711
Actively Recruiting
65
Seoul National University Hospital /ID# 255318
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
66
Yonsei University Health System Severance Hospital /ID# 256976
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
67
Samsung Medical Center /ID# 255284
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
68
Kyungpook National University Chilgok Hospital /ID# 255817
Daegu, South Korea, 41404
Actively Recruiting
69
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
Ferrol, A Coruna, Spain, 15405
Actively Recruiting
70
Hospital Infantil Universitario Nino Jesus /ID# 255012
Madrid, Spain, 28009
Actively Recruiting
71
Hospital Regional Universitario de Malaga /ID# 257553
Málaga, Spain, 29011
Actively Recruiting
72
Sodersjukhuset /ID# 255239
Stockholm, Stockholm County, Sweden, 118 83
Actively Recruiting
73
Astrid Lindgrens Barnsjukhus /ID# 255240
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
74
Sahlgrenska Universitetssjukhuset /ID# 255236
Gothenburg, Västra Götaland County, Sweden, 413 46
Actively Recruiting
75
University Children's Hospital Zurich - Eleonorenstiftung /ID# 255337
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
76
Inselspital, Universitaetsspital Bern /ID# 255321
Bern, Switzerland, 3010
Actively Recruiting
77
National Taiwan University Hospital /ID# 255679
Taipei City, Taipei, Taiwan, 100
Actively Recruiting
78
Changhua Christian Hospital /ID# 256082
Changhua City, Changhua County, Taiwan, 50006
Actively Recruiting
79
Gazi University Medical Faculty /ID# 255086
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
80
Sariyer Hamidiye Etfal Eğitim Ve Araştirma Hastanesi /ID# 257143
Istanbul, Turkey (Türkiye), 34453
Actively Recruiting
81
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020
Istanbul, Turkey (Türkiye), 34899
Actively Recruiting
82
Kocaeli University Med Faculty /ID# 256922
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
83
Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
Sheffield, England, United Kingdom, S10 2TH
Actively Recruiting
84
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
London, Greater London, United Kingdom, E1 2ES
Actively Recruiting
85
Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
Birmingham, United Kingdom, B4 6NH
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
15
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