Clinical trial • Phase III • Immunology|Musculoskeletal

JNJ-77242113 for Psoriatic arthritis|Active Psoriatic Arthritis

Phase III trial of JNJ-77242113 for Psoriatic arthritis|Active Psoriatic Arthritis.

Overview

Trial Therapeutic Area
Immunology|Musculoskeletal
Trial Disease
Psoriatic arthritis|Active Psoriatic Arthritis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
05-12-2024
First CTIS Authorization Date
02-04-2025

Trial design

Randomised, placebo-controlled: placebo tablet (jnj-77242113-aac placebo tablet) is specified as the control for jnj-77242113; placebo injections ("solution for injection in pre-filled syringe without ustekinumab 45/90") are provided as matching placebo for ustekinumab formulations. active study arms are jnj-77242113 200 mg and 400 mg (oral film-coated tablet) versus placebo; specific dosing schedule details are not provided in the ctis metadata. Phase III trial across 75 sites in Bulgaria, Czechia, Denmark and others.

Randomised
Yes
Comparator
Placebo-controlled: placebo tablet (JNJ-77242113-AAC Placebo tablet) is specified as the control for JNJ-77242113; placebo injections ("Solution for injection in pre-filled syringe without Ustekinumab 45/90") are provided as matching placebo for ustekinumab formulations. Active study arms are JNJ-77242113 200 mg and 400 mg (oral film-coated tablet) versus placebo; specific dosing schedule details are not provided in the CTIS metadata.
Target Sample Size
210
Trial Duration For Participant
700

Eligibility

Recruits 210 Vulnerable population flag is selected in the trial record. Participants must be adults (≥18 years). Subject information sheets and informed consent forms (L1 SIS and ICF) and several addenda are provided (multiple country-specific and language versions are listed among the study documents), indicating formal informed consent procedures; however the CTIS record does not provide detailed text excerpts describing special assent/consent handling for vulnerable subgroups in the available metadata..

Vulnerable Population
Vulnerable population flag is selected in the trial record. Participants must be adults (≥18 years). Subject information sheets and informed consent forms (L1 SIS and ICF) and several addenda are provided (multiple country-specific and language versions are listed among the study documents), indicating formal informed consent procedures; however the CTIS record does not provide detailed text excerpts describing special assent/consent handling for vulnerable subgroups in the available metadata.

Inclusion criteria

  • {"criterion_text":"- 1. At least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age.\n- 2. Have a diagnosis of PsA for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.\n- 3. Have active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at screening and at baseline; and b. C-reactive protein (CRP) ≥0.1 mg/dL at screening from the central laboratory. NOTE: A one-time repeat assessment of CRP level is allowed during the screening phase and the Investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.\n- 4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.\n- 5. Have active plaque psoriasis with at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis.\n- 6. Participants must be considered in the opinion of the investigator, to be a suitable candidate for treatment with ustekinumab per locally-approved labeling and have no contraindications to receive ustekinumab per local label.\n- 7. Have active PsA despite current or previous non-biologic DMARD and/or apremilast. Non-biologic DMARD (limited to MTX, SSZ, HCQ, or LEF) therapy is defined as taking a non-biologic DMARD for at least 12 weeks before first administration of study intervention, or evidence of non-biologic DMARD intolerance. Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 12 weeks before first administration of study intervention, or evidence of apremilast intolerance.\n- 8. If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 12 weeks prior and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a) If using MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg/week. b) If receiving SSZ, the dose must be stable and ≤ 3 g/day c) If receiving HCQ, the dose must be stable and ≤ 400 mg/day d) If receiving LEF, the dose must be stable and ≤ 20 mg/day (NOTE: use of LEF and MTX combination therapy is not allowed) If using apremilast at baseline, participants must be on a stable dose and ≤ 30 mg twice daily for at least 12 weeks before first administration of study intervention. If currently not using apremilast, the participant must not have received apremilast within 4 weeks before first administration of study intervention. If using NSAIDs for PsA at baseline, participants must be on a stable dose for at least 2 weeks before first administration of study intervention. If currently not using NSAIDs for PsA, must not have received NSAIDs for PsA within 2 weeks before first administration of study intervention. If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study intervention. If currently not using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks before first administration of study intervention."}

Exclusion criteria

  • {"criterion_text":"- 1. Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances.\n- 2. Currently has a malignancy or has a history of malignancy within 5 years prior to screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 12 weeks prior to the first study intervention administration).\n- 3. Has known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients, or to ustekinumab excipients (refer to the IB).\n- 4. Has unstable cardiovascular disease, defined as a clinical deterioration (eg, unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 12 weeks prior to screening or a cardiac hospitalization within the last 12 weeks prior to screening.\n- 5. Has other inflammatory diseases that might confound the evaluations of benefit of JNJ-77242113 therapy, including but not limited to RA, systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).\n- 6. Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator’s opinion, would have potential to interfere with efficacy assessments.\n- 27. Restricted or Prohibited Medication or Class of Medications: Has previously received the following agents for PsA or psoriasis: - JAK inhibitors, -TYK inhibitors (such as deucravacitinib) Restriction Duration: Ever (ie, any previous use is exclusionary)\n- 28. Restricted or Prohibited Medication or Class of Medications: Has previously received any biologic DMARDs for PsA or psoriasis such as: -Anti-IL-23 agents or biosimilars -Anti-IL-12/23 agents or biosimilars -Abatacept or biosimilars -Anti-IL-17 agent or biosimilars -Anti-TNFα agent or biosimilars Restriction Duration: Ever (ie, any previous use is exclusionary)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the American College of Rheumatology (ACR) 20 response at Week 16","definition_or_measurement_approach":"Measured as the American College of Rheumatology (ACR) 20 response at Week 16 (ACR20) as stated in the endpoint description."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
210
Recruitment Window Months
31
Consent Approach
Informed consent is via subject information sheets and informed consent forms (L1 SIS and ICF) with country- and language-specific versions and addenda provided (documents listed for BG, CZ, DK, DE, PL, ES, HU and English versions). Participants are adults (≥18) who provide their own consent; no assent process is described in the CTIS metadata.

Methods

  • Germany: multiple recruitment materials documented including awareness flyers, brochures, digital ads, print ads, letters and flyers (documents: 'REDACTED_K2_Recruitment material', 'Digital Ads', 'Print Ads', 'Flyer', 'Letter' in German).
  • Spain: awareness flyers, brochures and flyers for participant recruitment (documents: 'REDACTED_K2_Recruitment material' in Spanish).
  • Poland: digital outreach ads and participant recruitment flyers ('Digital Outreach Ads', 'Participant Recruitment Flyer').
  • Denmark: participant recruitment brochure and flyer (country-specific K1/K2 documents).
  • Czechia, Bulgaria, Hungary, Poland: country-specific recruitment brochures and participant recruitment materials (K1/K2 documents listed).
  • Digital channels are explicitly included (documents titled 'Digital Ads' / 'Digital Outreach Ads').

Geography

Total Number Of Sites
75
Total Number Of Participants
337

Bulgaria

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
437
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Medical Center Exacta Medica OOD
Principal Investigator Name
Krasimira Tsoneva
Principal Investigator Email
ktsoneva2011@abv.bg
Contact Person Name
Krasimira Tsoneva
Contact Person Email
ktsoneva2011@abv.bg
Site Name
Medical Center Medtech Services Ltd.
Principal Investigator Name
Krasimir Kraev
Principal Investigator Email
kkraev@hotmail.com
Contact Person Name
Krasimir Kraev
Contact Person Email
kkraev@hotmail.com
Site Name
Medical Center Artmed Ltd.
Principal Investigator Name
Mariela Geneva-Popova
Principal Investigator Email
genevapopova@yahoo.com
Contact Person Name
Mariela Geneva-Popova
Contact Person Email
genevapopova@yahoo.com
Site Name
Medical Center Teodora EOOD
Principal Investigator Name
Margarita Velkova
Principal Investigator Email
dr_margarita_velkova@gmai.bg
Contact Person Name
Margarita Velkova
Contact Person Email
dr_margarita_velkova@gmai.bg

Czechia

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
384
Number Of Sites
13
Number Of Participants
63

Sites

Site Name
MUDr. Zuzana Stejfova
Principal Investigator Name
Zuzana Stejfova
Principal Investigator Email
revma.ste@seznam.cz
Contact Person Name
Zuzana Stejfova
Contact Person Email
revma.ste@seznam.cz
Site Name
Medical Plus s.r.o.
Principal Investigator Name
Eva Dokoupilova
Principal Investigator Email
evadokoupil@gmail.com
Contact Person Name
Eva Dokoupilova
Contact Person Email
evadokoupil@gmail.com
Site Name
Revmatologie s.r.o.
Principal Investigator Name
Leona Prochazkova
Principal Investigator Email
revmatologie.prochazkova@seznam.cz
Contact Person Name
Leona Prochazkova
Site Name
Fakultni Nemocnice V Motole
Department Name
Oddeleni revmatologie deti a dospelych
Principal Investigator Name
Rudolf Horvath
Principal Investigator Email
rudolf.horvath@fnmotol.cz
Contact Person Name
Rudolf Horvath
Contact Person Email
rudolf.horvath@fnmotol.cz
Site Name
Rheuma s.r.o.
Principal Investigator Name
Jaroslava Spevakova
Principal Investigator Email
spevako.revma@seznam.cz
Contact Person Name
Jaroslava Spevakova
Contact Person Email
spevako.revma@seznam.cz
Site Name
Revmacentrum MUDr. Mostera s.r.o.
Principal Investigator Name
Erik Moster
Principal Investigator Email
info@revmacentrum.cz
Contact Person Name
Erik Moster
Contact Person Email
info@revmacentrum.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Principal Investigator Name
Libor Novosad
Principal Investigator Email
arthrocentrum@email.cz
Contact Person Name
Libor Novosad
Contact Person Email
arthrocentrum@email.cz
Site Name
PV Medical Services s.r.o.
Principal Investigator Name
Petr Vitek
Principal Investigator Email
pv.medical@seznam.cz
Contact Person Name
Petr Vitek
Contact Person Email
pv.medical@seznam.cz
Site Name
MUDr. Rosypalova s.r.o.
Principal Investigator Name
Miroslava Rosypalova
Principal Investigator Email
mirka.rosypalova@seznam.cz
Contact Person Name
Miroslava Rosypalova
Contact Person Email
mirka.rosypalova@seznam.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Klinika revmatologie a rehabilitace 3. LF UK a FTN
Principal Investigator Name
Petr Kopsa
Principal Investigator Email
petr.kopsa@ftn.cz
Contact Person Name
Petr Kopsa
Contact Person Email
petr.kopsa@ftn.cz
Site Name
Revmatologicky Ustav
Principal Investigator Name
Jana Tomasova Studynkova
Principal Investigator Email
tomasova@revma.cz
Contact Person Name
Jana Tomasova Studynkova
Contact Person Email
tomasova@revma.cz
Site Name
Revimex pro s.r.o.
Principal Investigator Name
Gabriela Stolarz
Principal Investigator Email
revimex@email.cz
Contact Person Name
Gabriela Stolarz
Contact Person Email
revimex@email.cz
Site Name
CCR Ostrava s.r.o.
Principal Investigator Name
Sylva Brtnikova
Principal Investigator Email
sylva.brtnikova@ccrostrava.com
Contact Person Name
Sylva Brtnikova
Contact Person Email
sylva.brtnikova@ccrostrava.com

Denmark

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
357
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Lillebaelt Hospital
Department Name
Reumatogy department
Principal Investigator Name
Myriam Liz Grana
Principal Investigator Email
myriam.liz.grana@rsyd.dk
Contact Person Name
Myriam Liz Grana
Contact Person Email
myriam.liz.grana@rsyd.dk
Site Name
Region Midtjylland
Department Name
Klinik for Led og bindevævssygdomme
Principal Investigator Name
Ellen Margrethe Hauge
Principal Investigator Email
ellen.hauge@aarhus.rm.dk
Contact Person Name
Ellen Margrethe Hauge
Contact Person Email
ellen.hauge@aarhus.rm.dk
Site Name
Odense University Hospital
Department Name
Reumatologisk Ambulatorium
Principal Investigator Name
Soeren Andreas Just
Principal Investigator Email
Soeren.Andreas.Just@rsyd.dk
Contact Person Name
Soeren Andreas Just
Contact Person Email
Soeren.Andreas.Just@rsyd.dk
Site Name
Region Midtjylland
Department Name
Medicinsk afdeling
Principal Investigator Name
René Oestgaard
Principal Investigator Email
reneoest@rm.dk
Contact Person Name
René Oestgaard
Contact Person Email
reneoest@rm.dk
Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Department of Rheumatology
Principal Investigator Name
Philip Rask Lage-Hansen
Principal Investigator Email
philip.rask.lage-hansen3@rsyd.dk
Contact Person Name
Philip Rask Lage-Hansen
Site Name
Frederiksberg Hospital
Department Name
Department of Rheumatology
Principal Investigator Name
Bjarke Brandt Hansen
Principal Investigator Email
bjarke.brandt.hansen@regionh.dk
Contact Person Name
Bjarke Brandt Hansen

Germany

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
366
Number Of Sites
10
Number Of Participants
29

Sites

Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentrum II Dr. Andrea Everding GmbH GbR
Principal Investigator Name
Andrea Everding
Principal Investigator Email
everding@hotmail.de
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Technische Universitaet Dresden
Department Name
Universitaetsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Stefan Beissert
Principal Investigator Email
Stefan.Beissert@ukdd.de
Contact Person Name
Stefan Beissert
Contact Person Email
Stefan.Beissert@ukdd.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
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Charité Mitte (CCM) Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
Principal Investigator Name
David Nils Simon
Principal Investigator Email
david.simon@charite.de
Contact Person Name
David Nils Simon
Contact Person Email
david.simon@charite.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
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum Ruhrgebiet
Principal Investigator Name
Ioana Andreica
Principal Investigator Email
Ioana.Andreica@elisabethgruppe.de
Contact Person Name
Ioana Andreica
Site Name
Eberhard Karls Universitaet Tuebingen
Department Name
Universitaetsklinikum Tuebingen / Universitaets-Hautklinik Psoriasiszentrum
Principal Investigator Name
Matthias Hahn
Principal Investigator Email
matthias.hahn@med.uni-tuebingen.de
Contact Person Name
Matthias Hahn
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Fachklinik Bad Bentheim Abteilung für Rheumatologie
Principal Investigator Name
Thomas Rath
Principal Investigator Email
t.rath@fk-bentheim.de
Contact Person Name
Thomas Rath
Contact Person Email
t.rath@fk-bentheim.de
Site Name
Medical Center - University Of Freiburg
Department Name
Universitaetsklinikum Freiburg Klinik f. Rheumatologie u. Klinische Immunologie
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
stephanie.finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
Johannes Wesling Klinikum Minden
Department Name
Klinik für Rheumatologie und klinische Immunologie
Principal Investigator Name
Gunter Assmann
Principal Investigator Email
gunter.assmann@muehlenkreiskliniken.de
Contact Person Name
Gunter Assmann

Poland

Earliest CTIS Part Ii Submission Date
10-01-2025
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
437
Number Of Sites
19
Number Of Participants
179

Sites

Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Torun
Principal Investigator Name
Slawomir Jeka
Principal Investigator Email
Idalia.Lewandowska@mics.medicover.com
Contact Person Name
Slawomir Jeka
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Department Name
Malopolskie Badania Kliniczne sp. z o.o.​
Principal Investigator Name
Bogdan Batko
Principal Investigator Email
biuro@mbk.clinic
Contact Person Name
Bogdan Batko
Contact Person Email
biuro@mbk.clinic
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa
Principal Investigator Name
Malgorzata Gryka-Marton
Principal Investigator Email
kontakt@medycynakliniczna.pl
Contact Person Name
Malgorzata Gryka-Marton
Contact Person Email
kontakt@medycynakliniczna.pl
Site Name
Specderm Poznanska Sp. j.
Department Name
SPECDERM Poznanska sp.j
Principal Investigator Name
Magdalena Bagrowska
Principal Investigator Email
badania@specderm.pl
Contact Person Name
Magdalena Bagrowska
Contact Person Email
badania@specderm.pl
Site Name
Reumed Sp. z o.o.
Department Name
Zespol Poradni Specjalistycznych REUMED Filia nr 1
Principal Investigator Name
Marcin Mazurek
Principal Investigator Email
reumedlublinpl@gmail.com
Contact Person Name
Marcin Mazurek
Contact Person Email
reumedlublinpl@gmail.com
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
„DERMED” Centrum Medyczne Sp. zo.o
Principal Investigator Name
Andrzej Kaszuba
Principal Investigator Email
gabinety@dermed.com.pl
Contact Person Name
Andrzej Kaszuba
Contact Person Email
gabinety@dermed.com.pl
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Department Name
Centrum Medyczne "All-med" Badania Kliniczne
Principal Investigator Name
Grazyna Pulka
Principal Investigator Email
allmed.recepcja@gmail.com
Contact Person Name
Grazyna Pulka
Contact Person Email
allmed.recepcja@gmail.com
Site Name
Ambulatorium Sp. z o.o.
Department Name
Ambulatorium Sp.zo.o
Principal Investigator Name
Anna Bazela-Ostromecka
Principal Investigator Email
ambulatorium@ambulatorium.pl
Contact Person Name
Anna Bazela-Ostromecka
Contact Person Email
ambulatorium@ambulatorium.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Ukladowych Chorob Tkanki laczne
Principal Investigator Name
Rafal Wojciechowski
Principal Investigator Email
reumatologia@biziel.pl
Contact Person Name
Rafal Wojciechowski
Contact Person Email
reumatologia@biziel.pl
Site Name
NZOZ Lecznica Mak Med s.c.
Department Name
NZOZ Lecznica MAK-MED. S.C.
Principal Investigator Name
Marek Krogulec
Principal Investigator Email
marekkrogulec@wp.pl
Contact Person Name
Marek Krogulec
Contact Person Email
marekkrogulec@wp.pl
Site Name
Centrum Medyczne Oporow
Department Name
Centrum Medyczne Oporow
Principal Investigator Name
Maria Misterska-Skora
Principal Investigator Email
badania@cmoporow.com
Contact Person Name
Maria Misterska-Skora
Contact Person Email
badania@cmoporow.com
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Gdynia
Principal Investigator Name
Anna Sylwestrzak
Principal Investigator Email
kontakt@pratia.com
Contact Person Name
Anna Sylwestrzak
Contact Person Email
kontakt@pratia.com
Site Name
Clinicmed Daniluk Nowak Sp. k.
Department Name
ClinicMed Daniluk, Nowak Sp.k.
Principal Investigator Name
Stefan Daniluk
Principal Investigator Email
rejestracja@clinicmed.pl
Contact Person Name
Stefan Daniluk
Contact Person Email
rejestracja@clinicmed.pl
Site Name
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Department Name
„Osteo-Medic” spolka cywilna Artur Racewicz, Jerzy Supronik
Principal Investigator Name
Artur Racewicz
Principal Investigator Email
sekretariat@osteo-medic.pl
Contact Person Name
Artur Racewicz
Contact Person Email
sekretariat@osteo-medic.pl
Site Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Department Name
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze spolka partnerska
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
Dermmedica Sp. z o.o.
Department Name
Centrum Columbus
Principal Investigator Name
Jolanta Weglowska
Principal Investigator Email
office@dermmedica.pl
Contact Person Name
Jolanta Weglowska
Contact Person Email
office@dermmedica.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Department Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski 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
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Principal Investigator Name
Ewa Matyska-Piekarska
Principal Investigator Email
info@reumatika.pl
Contact Person Name
Ewa Matyska-Piekarska
Contact Person Email
info@reumatika.pl

Spain

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
381
Number Of Sites
12
Number Of Participants
22

Sites

Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Rheumatology
Principal Investigator Name
Francisco Javier Blanco Garcia
Principal Investigator Email
fblagar@sergas.es
Contact Person Name
Francisco Javier Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Hospital Clinic De Barcelona
Department Name
Rheumatology
Principal Investigator Name
Julio Ramirez Garcia
Principal Investigator Email
julramga@gmail.com
Contact Person Name
Julio Ramirez Garcia
Contact Person Email
julramga@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Rheumatology
Principal Investigator Name
Elena Alonso Blanco-Morales
Principal Investigator Email
elenaabm@hotmail.com
Contact Person Name
Elena Alonso Blanco-Morales
Contact Person Email
elenaabm@hotmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Rheumatology
Principal Investigator Name
Antonio Fernandez Nebro
Principal Investigator Email
afnebro@gmail.com
Contact Person Name
Antonio Fernandez Nebro
Contact Person Email
afnebro@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Rheumatology
Principal Investigator Name
Jose Javier Perez Venegas
Principal Investigator Email
perez.venegas@gmail.com
Contact Person Name
Jose Javier Perez Venegas
Contact Person Email
perez.venegas@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Rheumatology
Principal Investigator Name
Beatriz Joven Ibañez
Principal Investigator Email
beatrizjoven@hotmail.com
Contact Person Name
Beatriz Joven Ibañez
Contact Person Email
beatrizjoven@hotmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Rheumatology
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
rblancovela@gmail.com
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
rblancovela@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Rheumatology
Principal Investigator Name
Alba Erra Duran
Principal Investigator Email
alba.erra@vallhebron.cat
Contact Person Name
Alba Erra Duran
Contact Person Email
alba.erra@vallhebron.cat
Site Name
Parc Tauli Hospital Universitari
Department Name
Rheumatology
Principal Investigator Name
Mireia Moreno Martinez-Losa
Principal Investigator Email
Moreno.parctauli@gmail.com
Contact Person Name
Mireia Moreno Martinez-Losa
Contact Person Email
Moreno.parctauli@gmail.com
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Rheumatology
Principal Investigator Name
Nadia Abdel-Kader Martin
Principal Investigator Email
abdelmartin@hotmail.com
Contact Person Name
Nadia Abdel-Kader Martin
Contact Person Email
abdelmartin@hotmail.com
Site Name
Hospital Quironsalud Sagrado Corazon
Department Name
Rheumatology
Principal Investigator Name
Paula Cejas
Principal Investigator Email
pcejashil@gmail.com
Contact Person Name
Paula Cejas
Contact Person Email
pcejashil@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Rheumatology
Principal Investigator Name
Clementina López Medina
Principal Investigator Email
clementinalopezmedina@gmail.com
Contact Person Name
Clementina López Medina

Hungary

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
449
Number Of Sites
11
Number Of Participants
22

Sites

Site Name
Vital-Medicina Kft.
Principal Investigator Name
Edit Drescher
Principal Investigator Email
dr.dreschere@gmail.com
Contact Person Name
Edit Drescher
Contact Person Email
dr.dreschere@gmail.com
Site Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Department Name
Department of Rheumatology
Principal Investigator Name
Bernadette Rojkovich
Principal Investigator Email
rojkovich.b@irgalmas.hu
Contact Person Name
Bernadette Rojkovich
Contact Person Email
rojkovich.b@irgalmas.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Department of Rheumatology
Principal Investigator Name
Judit Pulai
Principal Investigator Email
juditpulai@yahoo.com
Contact Person Name
Judit Pulai
Contact Person Email
juditpulai@yahoo.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Viktoria Csonka
Principal Investigator Email
viktoria.csonka@oec.hu
Contact Person Name
Viktoria Csonka
Contact Person Email
viktoria.csonka@oec.hu
Site Name
University Of Debrecen
Department Name
Department of Internal Medicine, Rheumatology
Principal Investigator Name
Nora Bodnar
Principal Investigator Email
drbodnarnora@gmail.com
Contact Person Name
Nora Bodnar
Contact Person Email
drbodnarnora@gmail.com
Site Name
Szolnoki Mav Korhaz Es Rendelointezet
Department Name
Department of Clinical Pharmacology
Principal Investigator Name
Laszlo Samson
Principal Investigator Email
samsonlaszlo59@gmail.com
Contact Person Name
Laszlo Samson
Contact Person Email
samsonlaszlo59@gmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Gyongyi Tatar
Principal Investigator Email
reuma@hotmail.hu
Contact Person Name
Gyongyi Tatar
Contact Person Email
reuma@hotmail.hu
Site Name
Revita Kft.
Principal Investigator Name
Marta Megyaszai
Principal Investigator Email
m.megyaszai@gmail.com
Contact Person Name
Marta Megyaszai
Contact Person Email
m.megyaszai@gmail.com
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Department of Rheumatology
Principal Investigator Name
Peter Keszthelyi
Principal Investigator Email
keszthelyi.peter@bmkk.eu
Contact Person Name
Peter Keszthelyi
Contact Person Email
keszthelyi.peter@bmkk.eu
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
University Of Szeged
Department Name
Rheumatology Clinic
Principal Investigator Name
Attila Balog
Principal Investigator Email
balog.attila@med.u-szeged.hu
Contact Person Name
Attila Balog
Contact Person Email
balog.attila@med.u-szeged.hu

Sponsor

Primary sponsor

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

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
codes: 6, 7
Name
4g Clinical LLC
Responsibilities
code: 3

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"codes: 6, 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"codes: 15 (Kit production), 4, 5, 6, 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
Authorisation Status
prodAuthStatus: 1 (recorded in CTIS productDictionaryInfo)
Starting Dose
200 mg
Dose Levels
200 mg; 400 mg
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 (marketingAuthNumber EU/1/08/494/001)
Starting Dose
45 mg
Dose Levels
45 mg
Maximum Dose
225 mg (max total dose amount listed)
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 (marketingAuthNumber EU/1/08/494/004)
Starting Dose
90 mg
Dose Levels
90 mg
Maximum Dose
450 mg (max total dose amount listed)
Investigational Product Name
JNJ-77242113-AAC Placebo tablet
Modality
Other
Routes Of Administration
ORAL USE (placebo)
Route
Oral (placebo)
Investigational Product Name
Solution for injection in pre-filled syringe without Ustekinumab 45
Modality
Other (placebo for injection)
Routes Of Administration
SUBCUTANEOUS USE (placebo)
Route
Subcutaneous (placebo)
Investigational Product Name
Solution for injection in pre-filled syringe without Ustekinumab 90
Modality
Other (placebo for injection)
Routes Of Administration
SUBCUTANEOUS USE (placebo)
Route
Subcutaneous (placebo)

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