Clinical trial • Phase III • Immunology|Dermatology

GUSELKUMAB for Chronic plaque psoriasis

Phase III trial of GUSELKUMAB for Chronic plaque psoriasis.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Chronic plaque psoriasis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Peptide/protein/enzyme
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
19-12-2023
First CTIS Authorization Date
17-01-2024

Trial design

Randomised, enbrel (etanercept) 50 mg solution for injection in pre-filled syringe; enbrel 25 mg powder and solvent for solution for injection. placebo arms: guselkumab 1 ml pfs placebo and guselkumab 0.5 ml varioject placebo. (no dosing schedules specified in the available data.)-controlled Phase III trial across 15 sites in Belgium, Germany, Hungary and others.

Randomised
Yes
Comparator
Enbrel (etanercept) 50 mg solution for injection in pre-filled syringe; Enbrel 25 mg powder and solvent for solution for injection. Placebo arms: Guselkumab 1 mL PFS Placebo and Guselkumab 0.5 mL Varioject Placebo. (No dosing schedules specified in the available data.)

Eligibility

Recruits 97 paediatric patients.

Vulnerable Population
Pediatric participants aged ≥6 to <18 years are included. The trial uses age-appropriate assent and consent processes: separate child, adolescent (including specific 16-17 assent), parent/guardian and parent-guardian consent forms and addenda are provided. Country-specific and language-specific information and consent/assent documents are supplied (examples in English, French, Dutch, Hungarian, German, Italian, Polish). Consent is obtained from parent(s)/guardian(s) and assent from minors as appropriate per age/region; documentation and versions for adolescents, children and parents/guardians are included in the submission.

Inclusion criteria

  • {"criterion_text":"- Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis [PsA]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (>=) 3, Psoriasis Area and Severity Index (PASI) >=12, >=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI>=20, >20% BSA involvement, or IGA=4\n- Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)\n- Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy\n- Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling\n- Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n- Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention"}

Exclusion criteria

  • {"criterion_text":"- Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)\n- Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)\n- Has previously received guselkumab or etanercept\n- Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers\n- Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly\n- The proportion of participants achieving an IGA score of cleared (0) or minimal (1) at Week 16."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The proportion of participants with a PASI 75 response at Week 16.","definition_or_measurement_approach":""}

Recruitment

Recruitment Window Months
93
Consent Approach
Informed consent is obtained from parent(s)/guardian(s) and assent from pediatric participants as appropriate. The submission includes separate subject information and informed consent form documents for adults/parents and age-specific assent documents for adolescents and children (including specific 16-17 assent forms), plus country-specific and language versions. Documents are available in multiple languages (English, French, Dutch, Hungarian, German, Italian, Polish) and include parent/guardian forms, child/adolescent assent forms, and addenda (e.g., COVID addenda) as required.

Geography

Total Number Of Sites
15
Total Number Of Participants
97

Belgium

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
568
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
CHU De Liege
Department Name
Dermatology
Principal Investigator Name
Arjen Nikkels
Principal Investigator Email
af.nikkels@chu.ulg.ac.be
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chu.ulg.ac.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology
Principal Investigator Name
Pierre-Dominique Ghislain
Principal Investigator Email
pierre-dominique.ghislain@uclouvain.be
Contact Person Name
Pierre-Dominique Ghislain
Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Principal Investigator Name
Jo Lambert
Principal Investigator Email
jo.lambert@ugent.be
Contact Person Name
Jo Lambert
Contact Person Email
jo.lambert@ugent.be

Germany

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
568
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Hautarztpraxis Dr. Leitz Und Kollegen
Principal Investigator Name
Nicolas Leitz
Principal Investigator Email
nicolas.leitz@gmail.com
Contact Person Name
Nicolas Leitz
Contact Person Email
nicolas.leitz@gmail.com
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Principal Investigator Name
Dagmar Wilsmann-Theis
Principal Investigator Email
dagmar.wilsmann-theis@ukbonn.de
Contact Person Name
Dagmar Wilsmann-Theis
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Principal Investigator Name
Stefan Beissert
Principal Investigator Email
stefan.beissert@uniklinikum-dresden.de
Contact Person Name
Stefan Beissert

Hungary

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
568
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
University Of Debrecen
Department Name
Dermatology
Principal Investigator Name
Andrea Szegedi
Principal Investigator Email
aszegedi@med.unideb.hu
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Department of Infant and Paediatrics
Principal Investigator Name
Erzsebet Szakos
Principal Investigator Email
szakose1@t-online.hu
Contact Person Name
Erzsebet Szakos
Contact Person Email
szakose1@t-online.hu
Site Name
Obudai Egeszsegugyi Centrum Kft.
Principal Investigator Name
Judit Noll
Principal Investigator Email
nolljudit@gmail.com
Contact Person Name
Judit Noll
Contact Person Email
nolljudit@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
568
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Azienda Ospedale-Universita Padova
Department Name
Dipartimento di Medicina DIMED
Principal Investigator Name
Anna Belloni Fortina
Principal Investigator Email
anna.bellonifortina@gmail.com
Contact Person Name
Anna Belloni Fortina
Contact Person Email
anna.bellonifortina@gmail.com
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dermatologia
Principal Investigator Name
Iria Neri
Principal Investigator Email
iria.neri@aosp.bo.it
Contact Person Name
Iria Neri
Contact Person Email
iria.neri@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dermatologia
Principal Investigator Name
Oriana Simonetti
Principal Investigator Email
oriana.simonetti@ospedaliriuniti.marche.it
Contact Person Name
Oriana Simonetti

Poland

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
568
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Uniwersyteckie Centrum Dermatologii Ogólnej i Onkologicznej
Principal Investigator Name
Wojciech Baran
Principal Investigator Email
wojciech.baran@umw.edu.pl
Contact Person Name
Wojciech Baran
Contact Person Email
wojciech.baran@umw.edu.pl
Site Name
Szpital Dzieciecy Im. Prof. Dr Med. Jana Bogdanowicza Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Pododdzial dermatologiczny
Principal Investigator Name
Dagmara Maranska
Principal Investigator Email
d.maranska@yahoo.pl
Contact Person Name
Dagmara Maranska
Contact Person Email
d.maranska@yahoo.pl
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
/
Principal Investigator Name
Andrzej Kaszuba
Principal Investigator Email
andrzej.kaszuba@dermed.com.pl
Contact Person Name
Andrzej Kaszuba
Contact Person Email
andrzej.kaszuba@dermed.com.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Imperial Clinical Research Services International Ltd.
Responsibilities
Materials

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Materials","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Tata Consultancy Services Deutschland GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Guselkumab
Active Substance
GUSELKUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
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
Authorised
Investigational Product Name
Guselkumab 1 mL PFS Placebo
Modality
Other
Investigational Product Name
Guselkumab 0.5 mL Varioject Placebo
Modality
Other
Investigational Product Name
Enbrel 50 mg solution for injection in pre-filled syringe
Active Substance
ETANERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
50 mg (product name)
Investigational Product Name
Enbrel 25 mg powder and solvent for solution for injection
Active Substance
ETANERCEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
25 mg (product name)

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