Actively Recruiting
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Led by AbbVie · Updated on 2026-05-13
120
Participants Needed
45
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC 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 maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 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 Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active ulcerative colitis with a modified Mayo Score from 5 to 9 and an endoscopic subscore of 2 to 3 confirmed by a central reader
- Intolerance or inadequate response to one or more drug types including aminosalicylates (except where not required), corticosteroids, systemic steroids, immunomodulators, and/or biologic therapies
- Documented ulcerative colitis history for at least 3 months before baseline, confirmed by colonoscopy and pathology results
You will not qualify if you...
- Major surgery within 12 weeks before baseline or planned during the study (such as hernia repair, gallbladder removal, or intestinal surgery)
- Clinically significant medical conditions other than ulcerative colitis or any condition that would interfere with participation or increase risk as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 45 locations
1
Phoenix Children's Hospital /ID# 273015
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Rady Children's Hospital /ID# 271873
San Diego, California, United States, 92123
Actively Recruiting
3
University of California San Francisco - Mission Bay /ID# 273022
San Francisco, California, United States, 94158
Actively Recruiting
4
Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585
Miami, Florida, United States, 33155
Actively Recruiting
5
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, Georgia, United States, 30342
Actively Recruiting
6
University of Chicago Medical Center /ID# 271588
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Goryeb Children's Hospital /ID# 271801
Morristown, New Jersey, United States, 07962
Actively Recruiting
8
University Hospitals Cleveland Medical Center /ID# 271831
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
The Children's Hospital of Philadelphia /ID# 273222
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Upmc Children'S Hospital Of Pittsburgh /ID# 272328
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
11
Patewood Medical Campus /ID# 272477
Greenville, South Carolina, United States, 29615
Actively Recruiting
12
Cliniques Universitaires UCL Saint-Luc /ID# 270123
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
13
Centre Hospitalier Régional de la Citadelle /ID# 270459
Liège, Liege, Belgium, 4000
Actively Recruiting
14
Hospital Universite Enfants Reine Fabiola /ID# 271860
Brussels, Belgium, 1020
Actively Recruiting
15
Hospital Pequeno Príncipe /ID# 271814
Curitiba, Paraná, Brazil, 80250-060
Actively Recruiting
16
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 271157
London, Ontario, Canada, N6A 5W9
Actively Recruiting
17
Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
Cottbus, Brandenburg, Germany, 03048
Actively Recruiting
18
Klinikum Kassel /ID# 271546
Kassel, Hesse, Germany, 34125
Actively Recruiting
19
Universitaetsklinikum Muenster /ID# 271898
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
20
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143
Athens, Attica, Greece, 11527
Actively Recruiting
21
University General Hospital Attikon /ID# 272361
Athens, Attica, Greece, 12462
Actively Recruiting
22
General Hospital of Thessaloniki Hippokrateio /ID# 271939
Thessaloniki, Greece, 54642
Actively Recruiting
23
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
24
Azienda Ospedaliera Universitaria Federico II /ID# 271895
Naples, Napoli, Italy, 80131
Actively Recruiting
25
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
Rome, Roma, Italy, 00168
Actively Recruiting
26
Ospedale Infantile Burlo Garofolo /ID# 274442
Trieste, Italy, 34137
Actively Recruiting
27
Tokyo Medical University Hospital /ID# 280850
Shinjuku-ku, Tokyo, Japan, 160-0023
Not Yet Recruiting
28
University Children's Hospital /ID# 269960
Belgrade, Beograd, Serbia, 11000
Actively Recruiting
29
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
Belgrade-Vračar, Beograd, Serbia, 11000
Actively Recruiting
30
Institute for Child and Youth Health Care of Vojvodina /ID# 269961
Novi Sad, Serbia, 21000
Actively Recruiting
31
Pusan National University Yangsan Hospital /ID# 272769
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
32
Seoul National University Hospital /ID# 272852
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
33
Kangbuk Samsung Hospital /ID# 273333
Seoul, Seoul Teugbyeolsi, South Korea, 03181
Actively Recruiting
34
Yonsei University Health System Severance Hospital /ID# 272894
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
35
Samsung Medical Center /ID# 272862
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
36
Hospital Teresa Herrera - CHUAC /ID# 271459
A Coruña, A Coruna, Spain, 15006
Actively Recruiting
37
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
38
Karolinska University Hospital Solna /ID# 271679
Solna, Stockholm County, Sweden, 171 64
Actively Recruiting
39
Sodersjukhuset /ID# 271678
Stockholm, Stockholm County, Sweden, 118 83
Actively Recruiting
40
Sahlgrenska Universitetssjukhuset /ID# 271675
Gothenburg, Västra Götaland County, Sweden, 413 46
Actively Recruiting
41
Taichung Veterans General Hospital /ID# 269242
Taichung, Taiwan, 407
Actively Recruiting
42
National Taiwan University Hospital /ID# 269244
Taipei, Taiwan, 100
Actively Recruiting
43
Addenbrookes Hospital /ID# 271489
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
44
Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
Sheffield, England, United Kingdom, S10 2TH
Actively Recruiting
45
Alder Hey Children's NHS Foundation Trust /ID# 271533
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
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