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|Small molecule

Key dates

Initial CTIS Submission Date
21-11-2023
First CTIS Authorization Date
19-03-2024

Trial design

Randomised, placebo (film-coated tablet without jnj-77242113) and active comparator deucravacitinib (deucravacitinib, film-coated tablet; dosing/schedule not specified).-controlled Phase III trial in Germany, Hungary, Romania and others.

Randomised
Yes
Comparator
Placebo (Film-Coated Tablet without JNJ-77242113) and active comparator Deucravacitinib (DEUCRAVACITINIB, film-coated tablet; dosing/schedule not specified).
Target Sample Size
356

Eligibility

Recruits 356 Vulnerable population selected; specific consent/assent handling not specified in the provided data..

Vulnerable Population
Vulnerable population selected; specific consent/assent handling not specified in the provided data.

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":"IGA score measured at Week 16; defined as IGA 0 or 1 and a ≥2-grade improvement from baseline."}
  • {"endpoint_text":"- PASI 90 at Week 16.","definition_or_measurement_approach":"PASI 90 measured at Week 16 (achievement of PASI 90 response vs baseline)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
356
Recruitment Window Months
44
Consent Approach
Informed consent obtained from participants (≥18 years). Subject information and informed consent form documents available in multiple languages (documents listed in English, German, Spanish, Hungarian, Polish, Italian, Romanian). Optional ICFs provided for genetic research, biopsy substudy, photography substudy, withdrawal, and pregnant partner.

Methods

  • Web posts (country-specific recruitment web posts listed for Germany)
  • Web advertisements (e.g., Web ad Short for Hungary)
  • Patient flyers and patient brochures (documents listed for Germany, Hungary, Poland)
  • Posters (Hungary)
  • Patient information brochures and study information materials (multiple countries)

Geography

Total Number Of Sites
51
Total Number Of Participants
374

Germany

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
763
Number Of Sites
17
Number Of Participants
62

Sites

Site Name
Hautarztpraxis Dr. Hoffmann
Department Name
dermatology, allergology, oncology
Contact Person Name
Matthias Hoffmann
Contact Person Email
drho@hautarzt-dr-hoffmann.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Klinikum Oldenburg AöR
Department Name
Dermatologie und Allergologie
Contact Person Name
Nikolaos Patsinakidis
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Department Name
Not Applicable
Contact Person Name
Johannes Niesmann
Site Name
Privatpraxis Dr. Hilton & Partner
Department Name
Dermatology, Venerology
Contact Person Name
Rodrigo da Mota
Contact Person Email
damota@dr-hilton.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatology
Contact Person Name
Athanasios Tsianakas
Site Name
Eurofins bioskin GmbH
Department Name
Research Center Dermatology
Contact Person Name
Swarna Ekanayake-Bohlig
Site Name
CRS Clinical Research Services Management GmbH
Department Name
Dermatology
Contact Person Name
Denise Barry
Contact Person Email
denise.barry@crs-group.de
Site Name
Technische Universitat Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Contact Person Name
Stefan Beissert
Site Name
Hms GmbH
Department Name
Dermatology
Contact Person Name
Sebastian Zimmer
Contact Person Email
science@hautmedizin-saar.de
Site Name
Hautarztpraxis Dr. Mihaescu
Department Name
Not Applicable
Contact Person Name
Virgil-Oreste Mihaescu
Contact Person Email
info@dr-mihaescu.de
Site Name
Hautzentrum Dülmen
Department Name
Not Applicable
Contact Person Name
Rolf Dominicus
Contact Person Email
praxis@hautzentrum-duelmen.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik
Contact Person Name
Petra Staubach-Renz
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Department Name
Not Applicable
Contact Person Name
Michael Sebastian
Contact Person Email
m.sebastian@derma-mahlow.de
Site Name
Derma-Study-Center Friedrichshafen GmbH
Department Name
Not Applicable
Contact Person Name
Peter Radny
Contact Person Email
info@dsc-fn.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Dermatology
Contact Person Name
Knut Schaekel
Site Name
Klinikum Darmstadt GmbH
Department Name
Dermatology
Contact Person Name
Mana zur Brügge

Hungary

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
780
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Uno Medical Trials Kft.
Department Name
Not Applicable
Contact Person Name
Eva Apostol
Contact Person Email
broadway21@freemail.hu
Site Name
Gyongyosi Bugat Pal Korhaz
Department Name
Borgyogyaszati szakrendeles
Contact Person Name
Andrea Mihalik
Contact Person Email
dr.mihalika@gmail.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Borgyogyaszati Osztaly
Contact Person Name
Ivan Orojan
Contact Person Email
orojani@kmk.hu

Romania

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
753
Number Of Sites
7
Number Of Participants
38

Sites

Site Name
Spitalul Clinic Judetean Mures
Department Name
Dermatology
Contact Person Name
Silviu Horia Morariu
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Dermatology
Contact Person Name
Ilarie Brihan
Contact Person Email
brihan_drm@yahoo.com
Site Name
CABINET MEDICAL DE DERMATO VENEROLOGIE Prof.Dr. ORASAN R. REMUS IOAN
Department Name
Dermatology
Contact Person Name
Remus Ioan Orasan
Contact Person Email
rorasan@yahoo.com
Site Name
Iasiprest S.R.L.
Department Name
Dermatology
Contact Person Name
Dorin Mihalache
Contact Person Email
office@iasiprest.ro
Site Name
Spitalul Clinic Judetean De Urgenta Craiova
Department Name
Dermatology
Contact Person Name
Elena Loredana Stoica
Contact Person Email
scjuc.craiova@gmail.com
Site Name
Newderm Clinic S.R.L.
Department Name
Dermatology
Contact Person Name
Caius Solovan
Contact Person Email
office@newdermclinic.ro
Site Name
Vitaplus Medclin S.R.L.
Department Name
Dermatology
Contact Person Name
Florin Marius Romanescu
Contact Person Email
office@vitaplusmedical.ro

Spain

Earliest CTIS Part Ii Submission Date
08-12-2023
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
826
Number Of Sites
11
Number Of Participants
44

Sites

Site Name
Hospital Universitario Virgen De Valme
Department Name
Dermatology
Contact Person Name
Amalia Perez Gil
Contact Person Email
amalia.perezgil@gmail.com
Site Name
Hospital Marina Baixa De La Vila Joiosa
Department Name
Dermatology
Contact Person Name
Javier Mataix Diaz
Contact Person Email
mataixdiaz@hotmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Dermatology
Contact Person Name
Manuel Javier Ginarte Val
Contact Person Email
Javier.Ginarte.Val@sergas.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Dermatology
Contact Person Name
Mariano Ara Gil
Contact Person Email
mariano_ara@yahoo.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Dermatology
Contact Person Name
Jose Manuel Carrascosa Carrillo
Contact Person Email
jmcarrascosac@hotmail.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Dermatology
Contact Person Name
Jose Luis Lopez Estebaranz
Contact Person Email
jlestebaranz@salud.madrid.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Dermatology
Contact Person Name
Lara Ferrandiz Pulido
Contact Person Email
lferrandiz@e-derma.org
Site Name
Hospital Universitario De Salamanca
Department Name
Dermatology
Contact Person Name
Monica Roncero Riesco
Contact Person Email
monironcero@hotmail.com
Site Name
Hospital De Manises
Department Name
Dermatology
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com
Site Name
Clinica Gaias Santiago
Department Name
Dermatology
Contact Person Name
Hae Jin Suh Oh
Contact Person Email
haejin@clinicasuh.com
Site Name
Hospital Clinic De Barcelona
Department Name
Dermatology
Contact Person Name
Josep Riera Monroig
Contact Person Email
jriera@clinic.cat

Poland

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
752
Number Of Sites
13
Number Of Participants
200

Sites

Site Name
Provita Sp. z o.o.
Department Name
Centrum Medyczne Angelius Provita
Contact Person Name
Anita Lewartowska-Bialek
Contact Person Email
badania-kliniczne@angelius.pl
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Contact Person Name
Agata Maciejewska-Radomska
Contact Person Email
tomaszpesta@etykaosrodek.pl
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Contact Person Name
Magdalena Nastalek
Contact Person Email
monika.patola.dzierwa@jci.pl
Site Name
Krakowskie Centrum Badan Klinicznych Sp. z o.o.
Contact Person Name
Marzena Czubak-Macugowska
Contact Person Email
badania@kcbk.com.pl
Site Name
Wromedica I Bielicka A Strzalkowska s.c.
Contact Person Name
Wojciech Baran
Contact Person Email
biuro@wromedica.pl
Site Name
Diamond Clinic Sp. z o.o.
Contact Person Name
Barbara Rewerska
Contact Person Email
prewerski@diamondclinic.eu
Site Name
Royalderm Agnieszka Nawrocka
Contact Person Name
Witold Owczarek
Contact Person Email
kontakt@royalderm.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Contact Person Name
Pawel Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Renew Clinic Sp. z o.o.
Contact Person Name
Hanna Mysliwiec
Contact Person Email
badania.koordynator@gmail.com
Site Name
Synexus Polska Sp. z o.o.
Department Name
Oddzial w Warszawie
Contact Person Name
Ryszard Galus
Site Name
Care Clinic Sp. z o.o.
Contact Person Name
Dominika Wcislo-Dziadecka
Contact Person Email
poczta@careclinic.katowice.pl
Site Name
Carpe Diem Centrum Medycyny Estetycznej
Contact Person Name
Weronika Molga
Contact Person Email
carpediem@carpediempl.eu
Site Name
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Contact Person Name
Elzbieta Klujszo
Contact Person Email
klujszoe@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties codes: [3]; contact: Maria.caulfield@almacgroup.com
Name
Labcorp Central Laboratory Services LP
Responsibilities
Kit production and laboratory services; contact: jean-paul.lewest@covance.com
Name
Eresearchtechnology Inc.
Responsibilities
clinical trial support functions (sponsorDuties codes 7,8); contact: David.Bailey@clario.com

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Kit production; sponsorDuties codes: [15,4,5,6,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: [7,8]","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 USE
Investigational Product Name
DEUCRAVACITINIB
Active Substance
DEUCRAVACITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
The commercially available tablets will be supplied as over-encapsulated capsules.
Investigational Product Name
Film-Coated Tablet without JNJ-77242113
Modality
Other
Investigational Product Name
Film-Coated Tablet without Deucravacitinib
Modality
Other

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