Clinical trial • Phase III • Immunology|Dermatology|Gastroenterology

GUSELKUMAB for Juvenile psoriatic arthritis|Ulcerative colitis|Crohn's disease

Phase III trial of GUSELKUMAB for Juvenile psoriatic arthritis|Ulcerative colitis|Crohn's disease. open-label, none/not specified-controlled.

Overview

Trial Therapeutic Area
Immunology|Dermatology|Gastroenterology
Trial Disease
Juvenile psoriatic arthritis|Ulcerative colitis|Crohn's disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
11-04-2024
First CTIS Authorization Date
05-07-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Italy, Belgium, Norway and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
93
Trial Duration For Participant
364

Eligibility

Recruits 93 paediatric patients.

Pregnancy Exclusion
2. Are pregnant, nursing, or planning pregnancy or fathering a child.
Vulnerable Population
Parents or their legally designated representative must sign an ICF and assent is required of children capable of understanding the nature of the study. "Parent(s) or their legally designated representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study."

Inclusion criteria

  • {"criterion_text":"- 1. Must have completed the dosing planned in the primary pediatric guselkumab study."}
  • {"criterion_text":"- 2. Received benefit from continued guselkumab therapy in the opinion of the investigator."}
  • {"criterion_text":"- 3. Before enrollment, a participant must be either: a. not of childbearing potential. OR b. Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure."}
  • {"criterion_text":"- 4. Parent(s) or their legally designated representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study."}
  • {"criterion_text":"- 5. Must be willing and able to adhere to the lifestyle restrictions specified in the protocol."}

Exclusion criteria

  • {"criterion_text":"- 1. Is ≥18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication. Is <18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication."}
  • {"criterion_text":"- 2. Are pregnant, nursing, or planning pregnancy or fathering a child."}
  • {"criterion_text":"- 3. Taken any disallowed therapies before the planned first LTE dose of study intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- No primary or secondary endpoints will be collected in this study.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
93
Recruitment Window Months
86
Consent Approach
Parents or their legally designated representative must sign an Informed Consent Form (ICF); assent is required of children capable of understanding the nature of the study. An adolescent who signs assent will be given the opportunity to sign an adult ICF when they reach the age of majority during the study. Country-specific subject information and consent/assent forms are provided (documents available in multiple languages as submitted for each member state: e.g. Italian, English, Spanish, Norwegian, Polish, Portuguese, French, German, Dutch).

Geography

Total Number Of Sites
23
Total Number Of Participants
85

Italy

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
11-02-2025
Processing Time Days
68
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Department of Maternal - Child
Principal Investigator Name
Patrizia Alvisi
Principal Investigator Email
patrizia.alvisi@ausl.bologna.it
Contact Person Name
Patrizia Alvisi
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Department of Maternal and Child Health / Pediatric Gastroenterology and Hepatology Unit
Principal Investigator Name
Salvatore Oliva
Principal Investigator Email
salvatore.oliva@uniroma1.it
Contact Person Name
Salvatore Oliva
Contact Person Email
salvatore.oliva@uniroma1.it
Site Name
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Department Name
Pediatrics
Principal Investigator Name
Matteo Bramuzzo
Principal Investigator Email
matteo.bramuzzo@burlo.trieste.it
Contact Person Name
Matteo Bramuzzo
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Paediatric Hepatology Gastroenterology and Transplantation
Principal Investigator Name
Naire Sansotta
Principal Investigator Email
nsansotta@asst-pg23.it
Contact Person Name
Naire Sansotta
Contact Person Email
nsansotta@asst-pg23.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Hepatogastroenterology and Nutrition
Principal Investigator Name
Daniela Knafelz
Principal Investigator Email
daniela.knafelz@opbg.net
Contact Person Name
Daniela Knafelz
Contact Person Email
daniela.knafelz@opbg.net
Site Name
Casa Sollievo Della Sofferenza
Department Name
UOC of Paediatrics
Principal Investigator Name
Maria Rosa Pastore
Principal Investigator Email
m.pastore@operapadrepio.it
Contact Person Name
Maria Rosa Pastore
Contact Person Email
m.pastore@operapadrepio.it

Belgium

Earliest CTIS Part Ii Submission Date
12-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
26
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
UZ Leuven
Department Name
Kindergastro-enterologie
Principal Investigator Name
Ilse Hoffman
Principal Investigator Email
ilse.hoffman@uzleuven.be
Contact Person Name
Ilse Hoffman
Contact Person Email
ilse.hoffman@uzleuven.be
Site Name
UZ Brussel
Department Name
Gastro-Enterology
Principal Investigator Name
Elisabeth De Greef
Principal Investigator Email
elisabeth.degreef@uzbrussel.be
Contact Person Name
Elisabeth De Greef
Contact Person Email
elisabeth.degreef@uzbrussel.be

Norway

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
25-04-2025
Processing Time Days
10
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Akershus University Hospital
Department Name
Department Pediatrics and Adolescent Medicine
Principal Investigator Name
Christopher Inchley
Principal Investigator Email
christopher.stephen.inchley@ahus.no
Contact Person Name
Christopher Inchley
Site Name
Oslo Universitetssykehus HF
Department Name
Pediatric Department Gastroenterology
Principal Investigator Name
Gori Perminow
Principal Investigator Email
goeper@ous-hf.no
Contact Person Name
Gori Perminow
Contact Person Email
goeper@ous-hf.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Department of Pediatrics and Neonatal Medicine
Principal Investigator Name
Lene Nymo Trulsen
Principal Investigator Email
lene.nymo.trulsen@unn.no
Contact Person Name
Lene Nymo Trulsen
Contact Person Email
lene.nymo.trulsen@unn.no

Germany

Earliest CTIS Part Ii Submission Date
16-01-2025
Latest Decision Or Authorization Date
28-01-2025
Processing Time Days
12
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Asklepios Klinik Sankt Augustin GmbH
Department Name
Zentrum Allgemeine Kinderheilkunde und Neonatologie
Principal Investigator Name
Gerd Horneff
Principal Investigator Email
g.horneff@asklepios.com
Contact Person Name
Gerd Horneff
Contact Person Email
g.horneff@asklepios.com
Site Name
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Principal Investigator Name
Ivan Foeldvari
Principal Investigator Email
foeldvari@t-online.de
Contact Person Name
Ivan Foeldvari
Contact Person Email
foeldvari@t-online.de

Poland

Earliest CTIS Part Ii Submission Date
25-11-2024
Latest Decision Or Authorization Date
10-03-2025
Processing Time Days
105
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Prof. Kierkuś
Principal Investigator Name
Monika Meglicka
Principal Investigator Email
m.meglicka@wip.waw.pl
Contact Person Name
Monika Meglicka
Contact Person Email
m.meglicka@wip.waw.pl
Site Name
Korczowski Bartosz, Gabinet Lekarski
Principal Investigator Name
Bartosz Korczowski
Principal Investigator Email
korczowski@op.pl
Contact Person Name
Bartosz Korczowski
Contact Person Email
korczowski@op.pl
Site Name
Instytut Pomnik Centrum Zdrowia Dziecka
Department Name
Klinika Gastroenterologii, Hepatologii, Zabiurzeń odżywiania i Pediatrii
Principal Investigator Name
Jaroslaw Kierkus
Principal Investigator Email
j.kierkus@ipczd.pl
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@ipczd.pl
Site Name
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Department Name
Ośrodek Badań Klinicznych
Principal Investigator Name
Anna Gruenpeter
Principal Investigator Email
anna.gruenpeter@gmail.com
Contact Person Name
Anna Gruenpeter
Contact Person Email
anna.gruenpeter@gmail.com
Site Name
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Department Name
Klinika i Poliklinika Reumatologii Wieku Rozwojowego
Principal Investigator Name
Piotr Gietka
Principal Investigator Email
piotr.gietka@spartanska.pl
Contact Person Name
Piotr Gietka
Contact Person Email
piotr.gietka@spartanska.pl

Portugal

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
11
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Pediatrics Service (Pediatric Gastroenterology Unit)
Principal Investigator Name
Eunice Trindade
Principal Investigator Email
eunice.trindade@ulssjoao.min-saude.pt
Contact Person Name
Eunice Trindade
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Pediatrics Service (Pediatric Gastroenterology Unit)
Principal Investigator Name
Ana Filipa Neiva
Principal Investigator Email
ana.neiva@hb.min-saude.pt
Contact Person Name
Ana Filipa Neiva
Contact Person Email
ana.neiva@hb.min-saude.pt

France

Earliest CTIS Part Ii Submission Date
03-10-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
14
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Department of Gastroenterology
Principal Investigator Name
Delphine LEY
Principal Investigator Email
delphine.ley@chu-lille.fr
Contact Person Name
Delphine LEY
Contact Person Email
delphine.ley@chu-lille.fr

Spain

Earliest CTIS Part Ii Submission Date
23-05-2024
Latest Decision Or Authorization Date
05-07-2024
Processing Time Days
43
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Rheumatology
Principal Investigator Name
Eva Maria Perez Pampin
Principal Investigator Email
eva.perez.pampin@sergas.es
Contact Person Name
Eva Maria Perez Pampin
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Gastroenterology
Principal Investigator Name
Ester Donat Aliaga
Principal Investigator Email
donat_est@gva.es
Contact Person Name
Ester Donat Aliaga
Contact Person Email
donat_est@gva.es

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
4g Clinical LLC
Responsibilities
3
Name
IQVIA Limited
Responsibilities
6
Name
Medidata Solutions Inc.
Responsibilities
7

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
1
Investigational Product Name
Guselkumab
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Authorisation Status
1
Investigational Product Name
Guselkumab
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBDERMAL USE
Route
SUBDERMAL
Authorisation Status
1

Related trials

Other published trials that may interest you.