Actively Recruiting
A Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate Safety of Guselkumab in Children With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
196
Participants Needed
42
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This study includes pediatric participants who have previously received guselkumab in primary studies and aims to monitor adverse events over an extended period. Participants who completed one of three primary pediatric guselkumab studies may join this long-term extension study if the investigator believes they will benefit from continued therapy. Guselkumab is given as a subcutaneous injection every 8 or 4 weeks, depending on the dosing regimen from the original study. Some participants have an option to adjust dosing frequency once during the extension, while others continue with their original schedule without changes. During the study, participants will have regular safety assessments focusing on treatment-emergent adverse events for up to nearly 7 years. Consent from parents or legal representatives and assent from children able to understand the study are required. Researchers will monitor participants closely, collecting data on safety and tolerability while allowing continued access to guselkumab throughout the extension period.
CONDITIONS
Brief Title
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have completed the dosing planned in the primary pediatric guselkumab study
- Must have received benefit from continued guselkumab therapy in the opinion of the investigator
- Must be either not of childbearing potential, or if of childbearing potential, not sexually active, practicing abstinence or using highly effective contraception and agree to continue during the study and for 12 weeks after the last dose
- Parent(s) or legal representative must sign informed consent
- Participants aged 7 years and older must provide assent when capable
You will not qualify if you...
- Participant aged 18 years or older living in a country where 2 years have passed since adult marketing authorization
- Participant under 18 years living in a country where 2 years have passed since pediatric marketing authorization
- Pregnant, nursing, or planning pregnancy or fathering a child
- Taken any disallowed therapies before first long-term extension dose
- Employee or family member of the investigator or study site involved in the study
- Any condition that the investigator believes could prevent, limit, or confound study assessments or is not in the participant's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years and 9 months
Participants receive guselkumab as a subcutaneous injection every 4 or 8 weeks, depending on their dosing regimen from the primary study. Dosing frequency may be adjusted based on investigator discretion and clinical status.
Visits every 4 or 8 weeks to receive guselkumab injections
Trial Site Locations
Total: 42 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States, 30342
Actively Recruiting
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
6
Instituto Caici
Rosario, Argentina, S2003CVB
Actively Recruiting
7
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, Australia, 6009
Actively Recruiting
8
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, Australia, 4101
Actively Recruiting
9
Capital Center For Children's health Capital Medical University
Beijing, China, 100020
Actively Recruiting
10
Changzhou No 2 Peoples Hospital
Changzhou, China, 213003
Actively Recruiting
11
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China, 310005
Actively Recruiting
12
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China, 310016
Actively Recruiting
13
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China, 200025
Actively Recruiting
14
Shengjing Hospital Of China Medical University
Shenyang, China, 110055
Actively Recruiting
15
Hospital Center University De Lille
Lille, France, 59000
Actively Recruiting
16
Schon Klinik Hamburg Eilbek
Hamburg, Germany, 22081
Actively Recruiting
17
Asklepios Klinik Sankt Augustin
Sankt Augustin, Germany, 53757
Actively Recruiting
18
ASST Papa Giovanni XXIII Bergamo
Bergamo, Italy, 24127
Actively Recruiting
19
Azienda USL di Bologna - Ospedale Maggiore
Bologna, Italy, 40121
Actively Recruiting
20
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
Actively Recruiting
21
IRCCS Materno Infantile Burlo Garofolo
Trieste, Italy, 34137
Actively Recruiting
22
Tokyo Metropolitan Children's Medical Center
Fuchū, Japan, 183 8561
Actively Recruiting
23
Kanazawa University Hospital
Kanazawa, Japan, 920 8641
Actively Recruiting
24
Kobe University Hospital
Kobe, Japan, 650 0017
Actively Recruiting
25
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan, 861 8520
Actively Recruiting
26
Shinshu University Hospital
Matsumoto, Japan, 390 8621
Actively Recruiting
27
Saga University Hospital
Saga, Japan, 849 0937
Actively Recruiting
28
Yokohama City University Medical Center
Yokohama, Japan, 232 0024
Actively Recruiting
29
Korczowski Bartosz Gabinet Lekarski
Rzeszów, Poland, 35-302
Actively Recruiting
30
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, Poland, 41 200
Actively Recruiting
31
Medical Network
Warsaw, Poland, 04-501
Actively Recruiting
32
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Actively Recruiting
33
Uls Braga - Hosp. Braga
Braga, Portugal, 4710 243
Actively Recruiting
34
Uls Sao Joao - Hosp. Sao Joao
Porto, Portugal, 4200 319
Actively Recruiting
35
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
36
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
37
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
38
Hosp. Univ. I Politecni La Fe
Valencia, Spain, 46026
Actively Recruiting
39
Gazi University Medical Faculty
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
40
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye), 34764
Actively Recruiting
41
Kocaeli Universitesi Hastanesi
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
42
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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