Clinical trial • Phase III • Immunology|Dermatology
JNJ-77242113 for Moderate to severe plaque psoriasis
Phase III trial of JNJ-77242113 for Moderate to severe plaque psoriasis.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Moderate to severe plaque psoriasis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-01-2025
- First CTIS Authorization Date
- 06-05-2025
Trial design
Randomised, active comparator: ustekinumab (stelara) — stelara 90 mg solution for injection in pre-filled syringe and stelara 45 mg solution for injection (doses 90 mg and 45 mg are specified); placebo controls: film-coated tablet without jnj-77242113 and solution for injection without ustekinumab (45 mg) and solution for injection in pre-filled syringe without ustekinumab (90) — schedule/frequency not specified in the record. Phase III trial in Austria, Germany, Poland and others.
- Randomised
- Yes
- Comparator
- Active comparator: Ustekinumab (STELARA) — STELARA 90 mg solution for injection in pre-filled syringe and STELARA 45 mg solution for injection (doses 90 mg and 45 mg are specified); Placebo controls: Film-Coated Tablet without JNJ-77242113 and Solution for injection without Ustekinumab (45 mg) and Solution for injection in pre-filled syringe without Ustekinumab (90) — schedule/frequency not specified in the record.
- Target Sample Size
- 273
Eligibility
Recruits 273 paediatric patients.
- Vulnerable Population
- Adolescents are included (minimum age ≥12 years) and the trial has selected vulnerable population status. Assent and parental/guardian consent procedures are provided (documents include Adolescent Assent, Child Assent, Parent/Guardian ICF, Optional Sample Assent/ICF, Optional Sub-study ICF). Materials and ICF/assent templates are available in multiple country/language versions as provided (examples: German, English, Portuguese, Polish, Hungarian, Spanish, French, Dutch, Danish). Parental/legal guardian consent is required for minors with adolescent/child assent as applicable.
Inclusion criteria
- {"criterion_text":"- 1.≥12 years of age at the screening visit."}
- {"criterion_text":"- 2. Diagnosis of moderate to severe plaque psoriasis, with or without PsA, for at least 26 weeks prior to the first administration of study intervention."}
- {"criterion_text":"- 3. Total BSA ≥10% at screening and baseline."}
- {"criterion_text":"- 4. Total PASI ≥12 at screening and baseline."}
- {"criterion_text":"- 5. Total IGA ≥3 at screening and baseline."}
Exclusion criteria
- {"criterion_text":"- 1.Nonplaque form of psoriasis"}
- {"criterion_text":"- 2.Current drug-induced psoriasis"}
- {"criterion_text":"- 3.A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances."}
- {"criterion_text":"- 4.Known allergies, hypersensitivity, or intolerance to JNJ-77242113, ustekinumab, or its excipients"}
- {"criterion_text":"- 5.Major surgical procedure (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgical procedure, or has a surgical procedure planned during the time the participant is expected to participate in the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16.","definition_or_measurement_approach":"IGA score of 0 or 1 and a ≥2 grade improvement from baseline at Week 16."}
- {"endpoint_text":"- PASI 90 at Week 16.","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 273
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent is obtained from adult participants and from parents/legal guardians for minors; adolescents/children provide assent. Multiple ICF and assent templates are provided (Adolescent Assent, Child Assent, Parent/Guardian ICF, Optional sample/optional sub-study ICF, Withdrawal forms, Pregnant partner ICF). Documents are provided in multiple country/language versions (examples: German, English, Portuguese, Polish, Hungarian, Spanish, French, Dutch, Danish) as indicated in the submitted materials.
Methods
- Social media and web posts / digital adverts (e.g., 'Adolescent Social Med Web AD', 'Social Media and Web Post') — country-specific versions indicated (DE, PL, PT, BE, DK, ES). Target audience: adolescents and caregivers.
- Patient flyers and study information brochures (e.g., 'Patient Flyer', 'Study Information Brochure') distributed via clinical sites and local channels — country-specific versions provided.
- Caregiver and adolescent brochures ('Caregiver and Adolescent Brochure') targeted to caregivers and adolescent participants.
- Dear Parent letters and emails (e.g., 'Dear Parent Letter', 'Dear Parent Email') targeted to parents/guardians of adolescent potential participants.
- Subject Wallet Card provided to participants ('Subject Wallet Card').
Geography
- Total Number Of Sites
- 69
- Total Number Of Participants
- 434
Austria
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 12-05-2025
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Klinik Hietzing
- Department Name
- Dermatologische Abteilung
- Principal Investigator Name
- Christian Posch
- Principal Investigator Email
- christian.posch@gesundheitsverbund.at
- Contact Person Name
- Christian Posch
- Contact Person Email
- christian.posch@gesundheitsverbund.at
- Site Name
- Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
- Department Name
- Abteilung für Dermatologie und Venerologie
- Principal Investigator Name
- Nina Haering
- Principal Investigator Email
- nina.haering@lkhf.at
- Contact Person Name
- Nina Haering
- Contact Person Email
- nina.haering@lkhf.at
- Site Name
- Noe LGA Gesundheit Region Mitte GmbH
- Department Name
- Klinische Abteilung für Haut- und Geschlechtskrankheiten
- Principal Investigator Name
- Knut Prillinger
- Principal Investigator Email
- knut.prillinger@stpoelten.lknoe.at
- Contact Person Name
- Knut Prillinger
- Contact Person Email
- knut.prillinger@stpoelten.lknoe.at
- Site Name
- Johannes Kepler University Linz
- Department Name
- Universitätsklinik für Dermatologie und Venerologie
- Principal Investigator Name
- Wolfram Hoetzenecker
- Principal Investigator Email
- Wolfram.Hoetzenecker@kepleruniklinikum.at
- Contact Person Name
- Wolfram Hoetzenecker
- Contact Person Email
- Wolfram.Hoetzenecker@kepleruniklinikum.at
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Dermatologie
- Principal Investigator Name
- Jonak Constanze
- Principal Investigator Email
- constanze.jonak@meduniwien.ac.at
- Contact Person Name
- Jonak Constanze
- Contact Person Email
- constanze.jonak@meduniwien.ac.at
Germany
- Earliest CTIS Part Ii Submission Date
- 23-04-2025
- Latest Decision Or Authorization Date
- 06-05-2025
- Processing Time Days
- 13
- Number Of Sites
- 13
- Number Of Participants
- 102
Sites
- Site Name
- Universitaet Muenster
- Department Name
- Universitätsklinikum Münster, Klinik für Hautkrankheiten
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- nina.magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- nina.magnolo@ukmuenster.de
- Site Name
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Principal Investigator Name
- Michael Sebastian
- Principal Investigator Email
- dr.sebastian@hautarztpraxis-mahlow.de
- Contact Person Name
- Michael Sebastian
- Contact Person Email
- dr.sebastian@hautarztpraxis-mahlow.de
- Site Name
- Hautarztpraxis Dr. Hoffmann
- Principal Investigator Name
- Matthias Hoffmann
- Principal Investigator Email
- drho@hautarzt-dr-hoffmann.de
- Contact Person Name
- Matthias Hoffmann
- Contact Person Email
- drho@hautarzt-dr-hoffmann.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Fachklinik Bad Bentheim Abteilung für Dermatologie
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Studienzentrum Dr. Schwarz
- Principal Investigator Name
- Beate Schwarz
- Principal Investigator Email
- beate@hautarzt-langenau.de
- Contact Person Name
- Beate Schwarz
- Contact Person Email
- beate@hautarzt-langenau.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Klinik fuer Dermatologie und Allergologie
- Principal Investigator Name
- Julia Welzel
- Principal Investigator Email
- julia.welzel@uk-augsburg.de
- Contact Person Name
- Julia Welzel
- Contact Person Email
- julia.welzel@uk-augsburg.de
- Site Name
- Studienzentrum an der Hase Weyergraf/Frick/Heiber GbR
- Principal Investigator Name
- Ansgar Weyergraf
- Principal Investigator Email
- aweyergraf_dzosn@web.de
- Contact Person Name
- Ansgar Weyergraf
- Contact Person Email
- aweyergraf_dzosn@web.de
- Site Name
- ISA Interdisciplinary Study Association GmbH
- Principal Investigator Name
- Margrit Simon
- Principal Investigator Email
- msimon@isa-research.de
- Contact Person Name
- Margrit Simon
- Contact Person Email
- msimon@isa-research.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Klinik für Dermatologie und Allergologie, Studienzentrum Dermatologie
- Principal Investigator Name
- Dagmar Wilsmann-Theis
- Principal Investigator Email
- dagmar.wilsmann-theis@ukbonn.de
- Contact Person Name
- Dagmar Wilsmann-Theis
- Contact Person Email
- dagmar.wilsmann-theis@ukbonn.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
- Principal Investigator Name
- Sascha Gerdes
- Principal Investigator Email
- sgerdes@dermatology.uni-kiel.de
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
- Site Name
- Rosenpark Research GmbH
- Principal Investigator Name
- Oliver Weirich
- Principal Investigator Email
- oliver.weirich@rosenparkresearch.de
- Contact Person Name
- Oliver Weirich
- Contact Person Email
- oliver.weirich@rosenparkresearch.de
- Site Name
- BAG Dres. med. Quist PartG
- Principal Investigator Name
- Sven Roy Quist
- Principal Investigator Email
- s.quist@dermatologie-quist.de
- Contact Person Name
- Sven Roy Quist
- Contact Person Email
- s.quist@dermatologie-quist.de
- Site Name
- Derma-Study-Center Friedrichshafen GmbH
- Principal Investigator Name
- Peter Radny
- Principal Investigator Email
- radny@dsc-fn.de
- Contact Person Name
- Peter Radny
- Contact Person Email
- radny@dsc-fn.de
Poland
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 13-05-2025
- Processing Time Days
- 15
- Number Of Sites
- 13
- Number Of Participants
- 150
Sites
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Department Name
- Klinika Ambroziak Dermatologia
- Principal Investigator Name
- Bartlomiej Kwiek
- Principal Investigator Email
- michal@klinikaambroziak.pl
- Contact Person Name
- Bartlomiej Kwiek
- Contact Person Email
- michal@klinikaambroziak.pl
- Site Name
- Care Clinic Sp. z o.o.
- Principal Investigator Name
- Dominika Wcislo-Dziadecka
- Principal Investigator Email
- poczta@careclinic.katowice.pl
- Contact Person Name
- Dominika Wcislo-Dziadecka
- Contact Person Email
- poczta@careclinic.katowice.pl
- Site Name
- Solumed Sp. z o.o. sp.k.
- Principal Investigator Name
- Kinga Adamska
- Principal Investigator Email
- office@solumed.pl
- Contact Person Name
- Kinga Adamska
- Contact Person Email
- office@solumed.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Joanna Maj
- Principal Investigator Email
- badania@cmoporow.com
- Contact Person Name
- Joanna Maj
- Contact Person Email
- badania@cmoporow.com
- Site Name
- Velocity Skierniewice Sp. z o.o.
- Principal Investigator Name
- Witold Urban
- Principal Investigator Email
- feasibility@VelocityClinical.com
- Contact Person Name
- Witold Urban
- Contact Person Email
- feasibility@VelocityClinical.com
- Site Name
- Specderm Poznanska Sp. j.
- Principal Investigator Name
- Maria Poznanska
- Principal Investigator Email
- badania@specderm.pl
- Contact Person Name
- Maria Poznanska
- Contact Person Email
- badania@specderm.pl
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- kontakt@ckb.elblag.pl
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- kontakt@ckb.elblag.pl
- Site Name
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
- Principal Investigator Name
- Agata Maciejewska-Radomska
- Principal Investigator Email
- tomaszpesta@etykaosrodek.pl
- Contact Person Name
- Agata Maciejewska-Radomska
- Contact Person Email
- tomaszpesta@etykaosrodek.pl
- Site Name
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy s.c.
- Principal Investigator Name
- Pawel Brzewski
- Principal Investigator Email
- info@dermatolog-brzewski.com
- Contact Person Name
- Pawel Brzewski
- Contact Person Email
- info@dermatolog-brzewski.com
- Site Name
- Dermed Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Andrzej Kaszuba
- Principal Investigator Email
- rejestracja.a2@dermed.com.pl
- Contact Person Name
- Andrzej Kaszuba
- Contact Person Email
- rejestracja.a2@dermed.com.pl
- Site Name
- Carpe Diem Centrum Medycyny Estetycznej
- Principal Investigator Name
- Weronika Molga
- Principal Investigator Email
- carpediem@carpediempl.eu
- Contact Person Name
- Weronika Molga
- Contact Person Email
- carpediem@carpediempl.eu
- Site Name
- Wromedica I Bielicka A Strzalkowska s.c.
- Principal Investigator Name
- Wojciech Baran
- Principal Investigator Email
- biuro@wromedica.pl
- Contact Person Name
- Wojciech Baran
- Contact Person Email
- biuro@wromedica.pl
- Site Name
- NZOZ ZDROWIE OSTEO-MEDIC
- Principal Investigator Name
- Malgorzata Janczylo-Jankowska
- Principal Investigator Email
- sekretariat@osteo-medic.pl
- Contact Person Name
- Malgorzata Janczylo-Jankowska
- Contact Person Email
- sekretariat@osteo-medic.pl
Hungary
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 07-05-2025
- Processing Time Days
- 44
- Number Of Sites
- 10
- Number Of Participants
- 75
Sites
- Site Name
- Medmare Bt.
- Principal Investigator Name
- Levente Kővágó
- Principal Investigator Email
- drkovago@gmail.com
- Contact Person Name
- Levente Kővágó
- Contact Person Email
- drkovago@gmail.com
- Site Name
- Derma-B Kft.
- Principal Investigator Name
- Emese Clemens-Herédi
- Principal Investigator Email
- emeseheredi@gmail.com
- Contact Person Name
- Emese Clemens-Herédi
- Contact Person Email
- emeseheredi@gmail.com
- Site Name
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Borgyogyaszati Osztaly
- Principal Investigator Name
- Ivan Orojan
- Principal Investigator Email
- orojani@kmk.hu
- Contact Person Name
- Ivan Orojan
- Contact Person Email
- orojani@kmk.hu
- Site Name
- Vasarhelyi Sarkanyfu Kft.
- Principal Investigator Name
- Eva Balazs
- Principal Investigator Email
- jimbies@gmail.hu
- Contact Person Name
- Eva Balazs
- Contact Person Email
- jimbies@gmail.hu
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Judit Noll
- Principal Investigator Email
- nolljudit@gmail.com
- Contact Person Name
- Judit Noll
- Contact Person Email
- nolljudit@gmail.com
- Site Name
- Gyoengyosi Bugat Pal Koerhaz
- Department Name
- Borgyogyaszati szakrendeles
- Principal Investigator Name
- Andrea Mihalik
- Principal Investigator Email
- dr.mihalika@gmail.com
- Contact Person Name
- Andrea Mihalik
- Contact Person Email
- dr.mihalika@gmail.com
- Site Name
- Allergo-Derm Bakos Kft.
- Principal Investigator Name
- Noémi Bakos
- Principal Investigator Email
- bakosnoemidr@gmail.com
- Contact Person Name
- Noémi Bakos
- Contact Person Email
- bakosnoemidr@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Bőrgyógyászat Klinika
- 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
- Uno Medical Trials Kft.
- Principal Investigator Name
- Eva Apostol
- Principal Investigator Email
- broadway21@freemail.hu
- Contact Person Name
- Eva Apostol
- Contact Person Email
- broadway21@freemail.hu
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- Borgyogyaszat
- Principal Investigator Name
- Beata Fabos
- Principal Investigator Email
- fabosbeata@gmail.com
- Contact Person Name
- Beata Fabos
- Contact Person Email
- fabosbeata@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 19-05-2025
- Processing Time Days
- 21
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Dermatology
- Principal Investigator Name
- Pedro Mendes Bastos
- Principal Investigator Email
- pedro.mm.bastos@cuf.pt
- Contact Person Name
- Pedro Mendes Bastos
- Contact Person Email
- pedro.mm.bastos@cuf.pt
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Tiago Torres
- Principal Investigator Email
- tiagotorres.dermatologia@chporto.min-saude.pt
- Contact Person Name
- Tiago Torres
- Contact Person Email
- tiagotorres.dermatologia@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude Da Regiao De Leiria E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Martinha Henrique
- Principal Investigator Email
- martinha.henrique@ulsrl.min-saude.pt
- Contact Person Name
- Martinha Henrique
- Contact Person Email
- martinha.henrique@ulsrl.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Miguel Coelho
- Principal Investigator Email
- miguel.coelho@ulssjose.min-saude.pt
- Contact Person Name
- Miguel Coelho
- Contact Person Email
- miguel.coelho@ulssjose.min-saude.pt
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Fernando Mota
- Principal Investigator Email
- fernandojrmota@gmail.com
- Contact Person Name
- Fernando Mota
- Contact Person Email
- fernandojrmota@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-04-2025
- Latest Decision Or Authorization Date
- 08-05-2025
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Dermatology
- Principal Investigator Name
- Jo Lambert
- Principal Investigator Email
- dermatologie@uzgent.be
- Contact Person Name
- Jo Lambert
- Contact Person Email
- dermatologie@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Dermatology
- Principal Investigator Name
- Tom Hillary
- Principal Investigator Email
- tom.hillary@uzleuven.be
- Contact Person Name
- Tom Hillary
- Contact Person Email
- tom.hillary@uzleuven.be
Spain
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 07-05-2025
- Processing Time Days
- 40
- Number Of Sites
- 16
- Number Of Participants
- 37
Sites
- Site Name
- Grupo Dermatologico Y Estetico Pedro Jaen S.A.
- Department Name
- Dermatology
- Principal Investigator Name
- Alvaro Gonzalez Cantero
- Principal Investigator Email
- alvarogc261893@hotmail.com
- Contact Person Name
- Alvaro Gonzalez Cantero
- Contact Person Email
- alvarogc261893@hotmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Dermatology
- Principal Investigator Name
- Maria Isabel Rodriguez Blanco
- Principal Investigator Email
- sabeblanco@gmail.com
- Contact Person Name
- Maria Isabel Rodriguez Blanco
- Contact Person Email
- sabeblanco@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Dermatology
- Principal Investigator Name
- Isabel Belinchon Romero
- Principal Investigator Email
- belinchon_isa@gva.es
- Contact Person Name
- Isabel Belinchon Romero
- Contact Person Email
- belinchon_isa@gva.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dermatology
- Principal Investigator Name
- Josep Riera Monroig
- Principal Investigator Email
- jriera@clinic.cat
- Contact Person Name
- Josep Riera Monroig
- Contact Person Email
- jriera@clinic.cat
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Tamara Gracia Cazana
- Principal Investigator Email
- tgraciac@salud.aragon.es
- Contact Person Name
- Tamara Gracia Cazana
- Contact Person Email
- tgraciac@salud.aragon.es
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Dermatology
- Principal Investigator Name
- Amelia Perez Gil
- Principal Investigator Email
- amalia.perezgil@gmail.com
- Contact Person Name
- Amelia Perez Gil
- Contact Person Email
- amalia.perezgil@gmail.com
- Site Name
- Hospital Marina Baixa De La Vila Joiosa
- Department Name
- Dermatology
- Principal Investigator Name
- Francisco Javier Mataix Diaz
- Principal Investigator Email
- mataixdiaz@hotmail.com
- Contact Person Name
- Francisco Javier Mataix Diaz
- Contact Person Email
- mataixdiaz@hotmail.com
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Dermatology
- Principal Investigator Name
- Jose Carlos Ruiz Carrascosa
- Principal Investigator Email
- ruizcarrascosa@movistar.es
- Contact Person Name
- Jose Carlos Ruiz Carrascosa
- Contact Person Email
- ruizcarrascosa@movistar.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Dermatology
- Principal Investigator Name
- Lara Ferrandiz Pulido
- Principal Investigator Email
- lferrandiz@e-derma.org
- Contact Person Name
- Lara Ferrandiz Pulido
- Contact Person Email
- lferrandiz@e-derma.org
- Site Name
- Hospital De Manises
- Department Name
- Dermatology
- Principal Investigator Name
- Antonio Martorell Calatayud
- Principal Investigator Email
- antmarto@hotmail.com
- Contact Person Name
- Antonio Martorell Calatayud
- Contact Person Email
- antmarto@hotmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Dermatology
- Principal Investigator Name
- Mar Llamas Velasco
- Principal Investigator Email
- mar.llamasvelasco@gmail.com
- Contact Person Name
- Mar Llamas Velasco
- Contact Person Email
- mar.llamasvelasco@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Dermatology
- Principal Investigator Name
- Raquel Rivera Diaz
- Principal Investigator Email
- raquel.rivera@salud.madrid.org
- Contact Person Name
- Raquel Rivera Diaz
- Contact Person Email
- raquel.rivera@salud.madrid.org
- Site Name
- Icr Medical S.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Alvaro Gonzalez Cantero
- Principal Investigator Email
- alvarogc261893@hotmail.com
- Contact Person Name
- Alvaro Gonzalez Cantero
- Contact Person Email
- alvarogc261893@hotmail.com
- Site Name
- Hospital Clinico Universitario Lozano Blesa
- Department Name
- Dermatology
- Principal Investigator Name
- Mariano Ara Martin
- Principal Investigator Email
- mariano_ara@yahoo.es
- Contact Person Name
- Mariano Ara Martin
- Contact Person Email
- mariano_ara@yahoo.es
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Dermatology
- Principal Investigator Name
- Olatz Lasa Elgezua
- Principal Investigator Email
- olatz.lasaelgezua@osakidetza.eus
- Contact Person Name
- Olatz Lasa Elgezua
- Contact Person Email
- olatz.lasaelgezua@osakidetza.eus
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Dermatology
- Principal Investigator Name
- Rafael Botella Estrada
- Principal Investigator Email
- rbotellaes@gmail.com
- Contact Person Name
- Rafael Botella Estrada
- Contact Person Email
- rbotellaes@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-04-2025
- Latest Decision Or Authorization Date
- 06-05-2025
- Processing Time Days
- 6
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Kawa Khaled Ajgeiy
- Principal Investigator Email
- kawa.ajgeiy@rsyd.dk
- Contact Person Name
- Kawa Khaled Ajgeiy
- Contact Person Email
- kawa.ajgeiy@rsyd.dk
- Site Name
- Gentofte Hospital
- Department Name
- Department of Dermatology and Allergy
- Principal Investigator Name
- Lone Skov
- Principal Investigator Email
- lone.skov.02@regionh.dk
- Contact Person Name
- Lone Skov
- Contact Person Email
- lone.skov.02@regionh.dk
- Site Name
- Region Hovedstaden
- Department Name
- Dep. Of Dermato-Venereology and wound healing
- Principal Investigator Name
- Simon Francis Thomsen
- Principal Investigator Email
- simon.francis.thomsen.02@regionh.dk
- Contact Person Name
- Simon Francis Thomsen
- Contact Person Email
- simon.francis.thomsen.02@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Afdeling for Hud- og Kønssygdomme
- Principal Investigator Name
- Kasper Fjellhauden Hjuler
- Principal Investigator Email
- kf.hjuler@rn.dk
- Contact Person Name
- Kasper Fjellhauden Hjuler
- Contact Person Email
- kf.hjuler@rn.dk
- Site Name
- Aarhus University Hospital
- Department Name
- Hud og kønssygdomme
- Principal Investigator Name
- Christian Vestergaard
- Principal Investigator Email
- chrivest@rm.dk
- Contact Person Name
- Christian Vestergaard
- Contact Person Email
- chrivest@rm.dk
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
- Sponsor third party (role code 3 indicated)
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Sponsor third party (role codes 7,8 indicated)
Third parties
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3 (role code provided in submission)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7, 8 (roles indicated by codes in submission)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"kit production; sponsorDuties codes: 15 (kit production), 4, 5, 6","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-77242113
- Active Substance
- JNJ-77242113
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Investigational (no marketing authorisation listed in record)
- Investigational Product Name
- STELARA 45 mg solution for injection
- Active Substance
- USTEKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation: EU/1/08/494/001)
- Starting Dose
- 45 mg
- Dose Levels
- 45 mg
- Investigational Product Name
- STELARA 90 mg solution for injection in pre-filled syringe
- Active Substance
- USTEKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Authorised (marketing authorisation: EU/1/08/494/004)
- Starting Dose
- 90 mg
- Dose Levels
- 90 mg
- Investigational Product Name
- Film-Coated Tablet without JNJ-77242113 (placebo)
- Modality
- Other
- Authorisation Status
- Not applicable (placebo)
- Investigational Product Name
- Solution for injection without Ustekinumab 45 (placebo injection)
- Modality
- Other
- Authorisation Status
- Not applicable (placebo)
- Investigational Product Name
- Solution for injection in pre-filled syringe without Ustekinumab 90 (placebo injection)
- Modality
- Other
- Authorisation Status
- Not applicable (placebo)
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