Clinical trial • Phase III • Immunology|Dermatology

JNJ-77242113 for Moderate to severe plaque psoriasis|Plaque psoriasis

Phase III trial of JNJ-77242113 for Moderate to severe plaque psoriasis|Plaque psoriasis.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Moderate to severe plaque psoriasis|Plaque psoriasis
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
11-09-2023
First CTIS Authorization Date
17-01-2024

Trial design

Randomised, active comparator: deucravacitinib (deucravacitinib) oral film-coated tablet (comparator). placebo comparators: film-coated tablet without jnj-77242113 and film-coated tablet without deucravacitinib. dose and schedule not specified in the ctis record.-controlled Phase III trial across 64 sites in France, Italy, Germany and others.

Randomised
Yes
Comparator
Active comparator: DEUCRAVACITINIB (DEUCRAVACITINIB) oral film-coated tablet (comparator). Placebo comparators: Film-Coated Tablet without JNJ-77242113 and Film-Coated Tablet without Deucravacitinib. Dose and schedule not specified in the CTIS record.
Target Sample Size
422

Eligibility

Recruits 422 The trial record indicates "isVulnerablePopulationSelected": true. Informed consent is handled via subject information sheets and informed consent forms (multiple L1/L2 documents listed). ICFs and participant information documents are available in country/language-specific versions (examples include DE, EN, ES, PL, HU). Participants must be ≥18 years of age and therefore provide their own consent; no assent for minors is specified in the criteria..

Vulnerable Population
The trial record indicates "isVulnerablePopulationSelected": true. Informed consent is handled via subject information sheets and informed consent forms (multiple L1/L2 documents listed). ICFs and participant information documents are available in country/language-specific versions (examples include DE, EN, ES, PL, HU). Participants must be ≥18 years of age and therefore provide their own consent; no assent for minors is specified in the criteria.

Inclusion criteria

  • {"criterion_text":"- 1. ≥18 years of age at the screening visit."}
  • {"criterion_text":"- 2. Diagnosis of 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, deucravacitinib, or to any of the excipients or components of the study intervention."}
  • {"criterion_text":"- 5. Major surgical procedure, 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":"Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) plus at least a 2-grade improvement from baseline assessed at Week 16."}
  • {"endpoint_text":"- PASI 90 at Week 16.","definition_or_measurement_approach":"PASI 90 defined as a 90% improvement from baseline in the Psoriasis Area and Severity Index, assessed at Week 16."}

Recruitment

Digital Remote Recruitment
True, digital methods documented include web posts and web advertisements (Web Post, Web ad long/short) used in country-specific recruitment packs (DE, ES, HU, etc.).
Planned Sample Size
422
Recruitment Window Months
40
Consent Approach
Informed consent is obtained via subject information sheets and informed consent forms (multiple L1/L2 SIS and ICF documents). Country/language-specific ICFs are available (examples: DE_GER, ES_SPA, PL_POL, HU_HUN, EN_ENG). Participants are adults (≥18) who provide their own consent. Additional ICF addenda/documents exist for pregnancy, withdrawal, optional genetic samples, biopsy and photography sub-studies.

Methods

  • Germany: Web Post (REDACTED_K2_Recruitment material Web Post I/II_DE_GER), Web ads (long/short), Patient Flyer, Patient Brochure; channels: online web posts and printed patient-facing materials; target audience: patients with moderate to severe plaque psoriasis (documents associatedEntityId 143346).
  • Spain: Patient Flyer, Patient Study Information Brochure, recruitment arrangements (REDACTED_K1_Recruitment Arrangements _ES_EN), web/print ads and patient brochures; channels: online and print; target audience: patients with moderate to severe plaque psoriasis (associatedEntityId 275845).
  • Poland: Recruitment Arrangements (REDACTED_K1_Recruitment Arrangements _PL_POL), subject wallet card and country-specific ICFs; channels: local patient-facing materials and clinic outreach (associatedEntityId 249706).
  • Hungary: Web ad short, Poster, Patient Brochure and country-specific recruitment materials; channels: online ads and printed posters/brochures (associatedEntityId 292226).
  • General/Multiple countries: Patient letters, print ads (short/long), web ads, posters, patient brochures and flyers, and other country-specific recruitment arrangements and materials as listed in the CTIS documents.

Geography

Total Number Of Sites
64
Total Number Of Participants
320

France

Earliest CTIS Part Ii Submission Date
21-11-2023
Latest Decision Or Authorization Date
22-01-2024
Processing Time Days
62
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Hopital Prive D Antony
Department Name
Dermatology
Contact Person Name
Pierre-Andre BECHEREL
Contact Person Email
p.becherel@ramsaygds.fr
Site Name
Hospital Hotel Dieu
Department Name
Dermatology
Contact Person Name
Helene AUBERT
Contact Person Email
helene.aubert@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Dermatology
Contact Person Name
Carle PAUL
Contact Person Email
paul.rc@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Dermatology
Contact Person Name
Julie CHARLES
Contact Person Email
jcharles@chu-grenoble.Fr
Site Name
CHU De Rouen
Department Name
Dermatology
Contact Person Name
Anne-Benedicte DUVAL-MODESTE
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Dermatology
Contact Person Name
Herve BACHELEZ
Contact Person Email
herve.bachelez@aphp.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Dermatology
Contact Person Name
Matthieu LEVAVASSEUR

Italy

Earliest CTIS Part Ii Submission Date
30-11-2023
Latest Decision Or Authorization Date
22-01-2024
Processing Time Days
53
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Dipartimento Medico Specialistico ed Oncologico
Contact Person Name
Paola Savoia
Site Name
University Hospital Of Ferrara
Department Name
Dipartimento Oncologico Medico Specialistico
Contact Person Name
Monica Corazza
Contact Person Email
monica.corazza@unife.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento di medicina clinica e chirurgia - università degli studi di napoli federico II
Contact Person Name
Matteo Megna
Contact Person Email
Matteo.megna@unina.it
Site Name
Presidio Ospedaliero San Giovanni Di Dio
Department Name
Unità operativa complessa di dermatologia, Ospedale UOC di Dermatologia AU di Cagliari
Contact Person Name
Laura Atzori
Contact Person Email
atzoril@unica.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Dermatologia
Principal Investigator Name
Carlo Giovanni Carrera
Principal Investigator Email
carlo.carrera@policlinico.mi.it
Contact Person Name
Carlo Giovanni Carrera
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita (duplicate record not specified)

Germany

Earliest CTIS Part Ii Submission Date
27-11-2023
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
837
Number Of Sites
15
Number Of Participants
76

Sites

Site Name
Rostock University Medical Center
Department Name
Medizinische Fakultät Klinik und Poliklinik für Dermatologie und Venerologie
Contact Person Name
Alexander Thiem
Site Name
Klinische Forschung Dresden GmbH
Contact Person Name
Peter Heymer
Contact Person Email
heymer@kfdd.de
Site Name
Universitaet Leipzig
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Jan Christoph Simon
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
Contact Person Name
Sascha Gerdes
Site Name
Studienzentrum an der Hase Weyergraf/Frick/Heiber
Contact Person Name
Ansgar Weyergraf
Contact Person Email
aweyergraf_dzosn@web.de
Site Name
Studienzentrum Dr. Schwarz
Contact Person Name
Beate Schwarz
Contact Person Email
beate@hautarzt-langenau.de
Site Name
Praxis Fuer Dermatologie Und Venerologie
Contact Person Name
Beatrice Gerlach
Contact Person Email
dr.b.gerlach@t-online.de
Site Name
ISA Interdisciplinary Study Association GmbH
Contact Person Name
Margrit Simon
Contact Person Email
msimon@isa-research.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein
Contact Person Name
Danielle Rogner
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
Contact Person Name
Matthias Augustin
Contact Person Email
m.augustin@uke.de
Site Name
MVZ Corius Potsdam GmbH
Contact Person Name
Khusru Asadullah
Contact Person Email
khusru@web.de
Site Name
Universitaetsklinikum Schleswig-Holstein (Lübeck)
Department Name
Institut für Entzündungsmedizin
Contact Person Name
Diamant Thaci
Contact Person Email
diamant.thaci@uksh.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Klinik f. Dermatologie, Venerologie u. Allergologie
Contact Person Name
Marthe-Lisa Schaarschmidt
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klinik für Dermatologie
Contact Person Name
Stephan Meller
Site Name
MENSINGDERMAresearch GmbH
Contact Person Name
Christian Mensing

Poland

Earliest CTIS Part Ii Submission Date
30-11-2023
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
835
Number Of Sites
16
Number Of Participants
128

Sites

Site Name
Solumed Centrum Medyczne Sp. z o.o.
Contact Person Name
Kinga Adamska
Contact Person Email
kingabyczkowska@gmail.com
Site Name
Centrum Medyczne Dr Rajzer Sp. z o.o.
Contact Person Name
Lidia Rajzer
Contact Person Email
pentagram2@wp.pl
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Ingrid Dadej-Michalska
Contact Person Email
i.dad@wp.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Contact Person Name
Bartlomiej Kwiek
Contact Person Email
principal@klinikaambroziak.pl
Site Name
Specderm Poznanska Sp. j.
Contact Person Name
Maria Poznanska
Contact Person Email
drmariapoznanska@specderm.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Contact Person Name
Pawel Brzewski
Contact Person Email
brzewski@gmail.com
Site Name
Promed P.Lach R.Glowacki Sp. j.
Contact Person Name
Anna Stepien
Contact Person Email
astepien@cmpromed.pl
Site Name
Dermmedica Sp. z o.o.
Contact Person Name
Jolanta Weglowska
Contact Person Email
jolaweglowska@tlen.pl
Site Name
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Contact Person Name
Malgorzata Janczylo-Jankowska
Contact Person Email
jjgosia@gmail.com
Site Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c
Contact Person Name
Rafal Czajkowski
Contact Person Email
r.czajkowski@dermodent.pl
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Contact Person Name
Jan Brzezicki
Contact Person Email
janisb@poczta.onet.pl
Site Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Contact Person Name
Wioletta Laszczewska
Contact Person Email
w.laszczewska@ctw.com.pl
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Contact Person Name
Andrzej Kaszuba
Contact Person Email
andrzej.kaszuba@dermed.com.pl
Site Name
Dorota Bystrzanowska High­ Med Przychodnia Specjalistyczna
Contact Person Name
Dorota Bystrzanowska
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Contact Person Name
Wojciech Baran
Contact Person Email
wojciech.baran@umed.wroc.pl
Site Name
Centrum Medyczne Oporow
Contact Person Name
Joanna Maj
Contact Person Email
joanna.maj@cmoporow.com

Spain

Earliest CTIS Part Ii Submission Date
04-10-2023
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
891
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Dermaology
Contact Person Name
Eva Vilarrasa Rull
Contact Person Email
Evilarrasa@santpau.cat
Site Name
Bellvitge University Hospital
Department Name
Dermatology
Contact Person Name
Jaime Notario Rosa
Contact Person Email
jnotario@bellvitgehospital.cat
Site Name
Hospital Universitario La Paz
Department Name
Dermatology
Contact Person Name
Pedro Herranz Pinto
Contact Person Email
pherranzp@gmail.com
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Dermatology
Contact Person Name
Jose Carlos Ruiz Carrascosa
Contact Person Email
ruizcarrascosa@movistar.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Dermatology
Contact Person Name
Ofelia Beniandres Rodriguez
Contact Person Email
ofelia_baniandres@yahoo.es
Site Name
Hospital Universitario De Cruces
Department Name
Dermatology
Contact Person Name
Olatz Lasa Elgezua
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatology
Contact Person Name
Isabel Belinchon Romero
Contact Person Email
belinchon_isa@gva.es
Site Name
Hospital Universitario De La Princesa
Department Name
Dermatology
Contact Person Name
Mar Llamas Velasco
Contact Person Email
mar.llamasvelasco@gmail.com
Site Name
Hospital Universitario Infanta Leonor
Department Name
Dermatology
Contact Person Name
Emilio del Rio Pena
Contact Person Email
edelrio97@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Dermatology
Contact Person Name
Raquel Rivera Diaz
Contact Person Email
raquel.rivera@salud.madrid.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Dermatology
Contact Person Name
Rafael Botella Estrada
Contact Person Email
rbotellaes@gmail.com
Site Name
Icr Medical S.L.
Department Name
Dermatology
Contact Person Name
Alvaro Gonzalez Cantero

Hungary

Earliest CTIS Part Ii Submission Date
09-11-2023
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
900
Number Of Sites
8
Number Of Participants
36

Sites

Site Name
Derma-B Kft.
Contact Person Name
Emese Clemens-Herédi
Contact Person Email
emeseheredi@gmail.com
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Borgyogyaszat
Contact Person Name
Beata Fabos
Contact Person Email
fabosbeata@gmail.com
Site Name
Allergo-Derm Bakos Kft.
Contact Person Name
Noémi Bakos
Contact Person Email
bakosnoemidr@gmail.com
Site Name
University Of Szeged
Department Name
Bőrgyógyászati és Allergológiai Klinika
Contact Person Name
Rolland Gyulai
Site Name
University Of Pecs
Department Name
Bőrgyógyászati Klinika
Contact Person Name
Mehdi Moezzi
Contact Person Email
moezzi.mehdi@pte.hu
Site Name
University Of Debrecen
Department Name
Bőrgyógyaszat Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Obudai Egeszsegugyi Centrum Kft.
Contact Person Name
Judit Noll
Contact Person Email
nolljudit@gmail.com
Site Name
Medmare Bt.
Contact Person Name
Levente Pál Kővágó
Contact Person Email
drkovago@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: 7, 8 (as listed); contact email: David.Bailey@clario.com
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties code: 3 (as listed); contact email: Maria.caulfield@almacgroup.com
Name
Labcorp Central Laboratory Services LP
Responsibilities
Kit production (code 15) and sponsorDuties codes 4,5,6,8; contact email: jean-paul.lewest@covance.com

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7, 8 (as listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3 (as listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 15 (Kit production), 4, 5, 6, 8 (as listed)","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
prodAuthStatus:1; euMpNumber:PRD10321777
Investigational Product Name
DEUCRAVACITINIB
Active Substance
DEUCRAVACITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
oral
Authorisation Status
prodAuthStatus:2; euSubstNumber:SUB214583
Investigational Product Name
Film-Coated Tablet without JNJ-77242113 (placebo)
Modality
Other
Authorisation Status
authorisationCountryCode: IS (as listed)
Investigational Product Name
Film-Coated Tablet without Deucravacitinib (placebo)
Modality
Other
Authorisation Status
authorisationCountryCode: IS (as listed)

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