Clinical trial • Phase III • Immunology
JNJ-77242113 for Psoriatic arthritis
Phase III trial of JNJ-77242113 for Psoriatic arthritis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Psoriatic arthritis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 10-12-2024
- First CTIS Authorization Date
- 14-04-2025
Trial design
Randomised, active arms: jnj-77242113 tablets (oral) at 200 mg and 400 mg; comparator: jnj-77242113-aac placebo tablet (placebo).-controlled Phase III trial across 88 sites in Bulgaria, Czechia, Denmark and others.
- Randomised
- Yes
- Comparator
- Active arms: JNJ-77242113 tablets (oral) at 200 mg and 400 mg; Comparator: JNJ-77242113-AAC Placebo tablet (placebo).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 349
Eligibility
Recruits 349 Vulnerable population selected (isVulnerablePopulationSelected=true). Country-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF) are provided; no further details on assent/consent handling (e.g., parental consent, assent) are available in the provided data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Country-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF) are provided; no further details on assent/consent handling (e.g., parental consent, assent) are available in the provided data.
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- 6.1 Criterion modified per Amendment 2 Participants must have been previously treated with 1 biologic agent for PsA or psoriasis and have discontinued treatment for any reason. The reason for discontinuation must be documented. -If the reason for discontinuation is lack of benefit to a biologic therapy, this is defined as: lack of benefit, as assessed by the treating physician, after at least 12 weeks of abatacept, etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar), at least 14 weeks of infliximab (or biosimilar), or 16 weeks of anti-IL-17 therapy at an approved dose for PsA or psoriasis. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or PsA or psoriasis disease activity. -If the reason for discontinuation is intolerance to a biologic therapy, this is defined as: Intolerance to a biologic therapy for PsA or psoriasis, as assessed by the treating physician. -If the reason for discontinuation is other than the above, the reason for discontinuation must be specified and documented and it may include financial reasons, sub-optimal dosing, etc. NOTE: Switching from an original biologic to the biosimilar of the same original biologic or vice versa, is considered as use of 1 biologic agent for PsA or psoriasis.\n- 7. 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 ofLEF 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. The maximum allowed dose is the marketed dose approved in the country where the study is being conducted. 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 (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 the following biologic DMARDs for PsA or psoriasis: - Anti-IL-23 agents or biosimilars; - Anti-IL-12/23 agents or biosimilars. Restriction Duration: Ever (ie, any previous use is exclusionary)\n- 29. Restricted or Prohibited Medication or Class of Medications: Has previously received the following biologic agents for PsA or psoriasis: - Anti-TNFα agents or biosimilars, anti-IL-17 agents or biosimilars, or abatacept or biosimilars. Restriction Duration: 30 days or 5 half-lives (whichever is longer) prior to the first administration of study intervention"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the American College of Rheumatology (ACR) 20 response at Week 16","definition_or_measurement_approach":"American College of Rheumatology (ACR) 20 response assessed at Week 16"}
Recruitment
- Digital Remote Recruitment
- True, digital methods documented (Digital Outreach Ads and Digital Ads for Poland, Romania, Germany and other digital recruitment materials referenced in country-specific recruitment packages).
- Planned Sample Size
- 349
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent is obtained using country-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF). ICF/SIS documents are provided in multiple country-language versions (examples include Italian, Spanish, Polish, Hungarian, Czech, Romanian, Bulgarian, German, English). Documents include clinical ICFs and addenda (e.g., pregnancy/pregnant partner, optional genetic sample, withdrawal, LTE addenda). Participants must be ≥18 years of age so consent is provided by the participant; no assent process for minors is described in the provided data.
Methods
- Country-specific participant recruitment flyers / brochures / invitation letters (documents available for Italy, Spain, Poland, Germany, Romania, Denmark, Bulgaria, Czechia, Hungary) — channel: printed and PDF materials distributed to potential participants; target audience: patients with active Psoriatic Arthritis.
- Digital outreach / digital advertisements (documents labelled Digital Outreach Ads for Poland and Romania; Digital Ads/Digital Outreach for Germany) — channel: online/digital advertising; target audience: potential participants/patients with PsA in country-specific markets.
- Print advertisements (Germany) — channel: print ads; target audience: potential participants with PsA.
- Participant recruitment brochures and flyers (multiple countries) and participant invitation letters (Italy) — channel: direct mail / clinic distribution; target: clinic patients and potential study participants.
Geography
- Total Number Of Sites
- 88
- Total Number Of Participants
- 401
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 15-01-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 391
- Number Of Sites
- 8
- Number Of Participants
- 24
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of Rheumatology
- Principal Investigator Name
- Rasho Rashkov
- Principal Investigator Email
- proff_rashkov@yahoo.com
- Contact Person Name
- Rasho Rashkov
- Contact Person Email
- proff_rashkov@yahoo.com
- Site Name
- Diagnostic Consulting Center 1 Sliven EOOD
- Principal Investigator Name
- Aneliya Koleva
- Principal Investigator Email
- dr_koleva@dir.bg
- Contact Person Name
- Aneliya Koleva
- Contact Person Email
- dr_koleva@dir.bg
- Site Name
- University Multiprofessional Hospital For Active Treatment Plovdiv AD
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Ivan Goranov
- Principal Investigator Email
- goranov_ivan@yahoo.com
- Contact Person Name
- Ivan Goranov
- Contact Person Email
- goranov_ivan@yahoo.com
- Site Name
- Medical Center Excelsior OOD
- Principal Investigator Name
- Tzvetanka Petranova
- Principal Investigator Email
- dr_petranova@yahoo.com
- Contact Person Name
- Tzvetanka Petranova
- Contact Person Email
- dr_petranova@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Kaspela EOOD
- Department Name
- Rheumatology Clinic
- Principal Investigator Name
- Anastas Batalov
- Principal Investigator Email
- abatalov@hotmail.com
- Contact Person Name
- Anastas Batalov
- Contact Person Email
- abatalov@hotmail.com
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Principal Investigator Name
- Delina Ivanova
- Principal Investigator Email
- delina_ivanov@abv.bg
- Contact Person Name
- Delina Ivanova
- Contact Person Email
- delina_ivanov@abv.bg
- Site Name
- Амбулатория За Специализирана Извънболнична Медицинска Помощ Ревматологичен Център Света Ирина ЕООD
- Principal Investigator Name
- Rodina Nestorova Licheva
- Principal Investigator Email
- rodina_usd@yahoo.com
- Contact Person Name
- Rodina Nestorova Licheva
- Contact Person Email
- rodina_usd@yahoo.com
- Site Name
- Mbal Lyulin EAD
- Department Name
- Rheumatology department
- Principal Investigator Name
- Aneliya Radikova
- Principal Investigator Email
- a.radikova@mail.bg
- Contact Person Name
- Aneliya Radikova
- Contact Person Email
- a.radikova@mail.bg
Czechia
- Earliest CTIS Part Ii Submission Date
- 27-03-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 316
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- L.K.N. Arthrocentrum s.r.o.
- Principal Investigator Name
- Libor Novosad
- Principal Investigator Email
- libor.novosad@email.cz
- Contact Person Name
- Libor Novosad
- Contact Person Email
- libor.novosad@email.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
- 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
- Contact Person Email
- revmatologie.prochazkova@seznam.cz
- Site Name
- Revmacentrum MUDr. Mostera s.r.o.
- Principal Investigator Name
- Erik Moster
- Principal Investigator Email
- emoster@revmacentrum.cz
- Contact Person Name
- Erik Moster
- Contact Person Email
- emoster@revmacentrum.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 Nemocnice V Motole
- Department Name
- Oddeleni revmatologie deti a dospelych
- Principal Investigator Name
- Rudolf Horvsth
- Principal Investigator Email
- rudolf.horvath@fnmotol.cz
- Contact Person Name
- Rudolf Horvsth
- Contact Person Email
- rudolf.horvath@fnmotol.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
- 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
Denmark
- Earliest CTIS Part Ii Submission Date
- 21-03-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 319
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- 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
- 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
- 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
- Contact Person Email
- bjarke.brandt.hansen@regionh.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
- Contact Person Email
- philip.rask.lage-hansen3@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
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 336
- Number Of Sites
- 9
- Number Of Participants
- 40
Sites
- 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
- 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
- Contact Person Email
- matthias.hahn@med.uni-tuebingen.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
- Contact Person Email
- stephanie.finzel@uniklinik-freiburg.de
- 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
- Studienambulanz Rheumazentrum Ratingen GbR
- Department Name
- Rheumazentrum Ratingen; Rheumaforschung - Studienambulanz
- Principal Investigator Name
- Siegfried Wassenberg
- Principal Investigator Email
- wassenberg@rhzr.de
- Contact Person Name
- Siegfried Wassenberg
- Contact Person Email
- wassenberg@rhzr.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
- Contact Person Email
- Ioana.Andreica@elisabethgruppe.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
Italy
- Earliest CTIS Part Ii Submission Date
- 02-04-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 310
- Number Of Sites
- 11
- Number Of Participants
- 32
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UO Reumatologia e Immunologia
- Principal Investigator Name
- Carlo Francesco Selmi
- Principal Investigator Email
- carlo.selmi@hunimed.eu
- Contact Person Name
- Carlo Francesco Selmi
- Contact Person Email
- carlo.selmi@hunimed.eu
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare
- Principal Investigator Name
- Lorenzo Dagna
- Principal Investigator Email
- dagna.lorenzo@unisr.it
- Contact Person Name
- Lorenzo Dagna
- Contact Person Email
- dagna.lorenzo@unisr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Francesco Ciccia
- Principal Investigator Email
- francesco.ciccia@unicampania.it
- Contact Person Name
- Francesco Ciccia
- Contact Person Email
- francesco.ciccia@unicampania.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UO Reumatologia
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD Clinica Medica
- Principal Investigator Name
- Michele Maria Luchetti
- Principal Investigator Email
- m.luchetti@staff.univpm.it
- Contact Person Name
- Michele Maria Luchetti
- Contact Person Email
- m.luchetti@staff.univpm.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC di Reumatologia
- Principal Investigator Name
- Maria Antonietta D'Agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D'Agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Bruno Frediani
- Principal Investigator Email
- fredianibruno60@gmail.com
- Contact Person Name
- Bruno Frediani
- Contact Person Email
- fredianibruno60@gmail.com
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Clinica di Reumatologia
- Principal Investigator Name
- Alen Zabotti
- Principal Investigator Email
- zabottialen@gmail.com
- Contact Person Name
- Alen Zabotti
- Contact Person Email
- zabottialen@gmail.com
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- UOC Reumatologia
- Principal Investigator Name
- Maria Sole Chimenti
- Principal Investigator Email
- msolechimenti@hotmail.com
- Contact Person Name
- Maria Sole Chimenti
- Contact Person Email
- msolechimenti@hotmail.com
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Reumatologia
- Principal Investigator Name
- Francesca Bobbio Pallavicini
- Principal Investigator Email
- f.bobbiopallavicini@smatteo.pv.it
- Contact Person Name
- Francesca Bobbio Pallavicini
- Contact Person Email
- f.bobbiopallavicini@smatteo.pv.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- S.C. Reumatologia e Immunologia Clinica
- Principal Investigator Name
- Roberto Gorla
- Principal Investigator Email
- roberto.gorla@asst-spedalicivili.it
- Contact Person Name
- Roberto Gorla
- Contact Person Email
- roberto.gorla@asst-spedalicivili.it
Spain
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 327
- Number Of Sites
- 10
- Number Of Participants
- 25
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Rheumatology
- Principal Investigator Name
- Eva Perez Pampin
- Principal Investigator Email
- eva.perez.pampin@sergas.es
- Contact Person Name
- Eva Perez Pampin
- Contact Person Email
- eva.perez.pampin@sergas.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Rheumatology
- Principal Investigator Name
- Laura Berbel Arcobe
- Principal Investigator Email
- lberbel@bellvitgehospital.cat
- Contact Person Name
- Laura Berbel Arcobe
- Contact Person Email
- lberbel@bellvitgehospital.cat
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Rheumatology
- Principal Investigator Name
- Maria Teresa Navio Marco
- Principal Investigator Email
- mteresa.navio@salud.madrid.org
- Contact Person Name
- Maria Teresa Navio Marco
- Contact Person Email
- mteresa.navio@salud.madrid.org
- 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 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
- 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 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 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 Universitario Reina Sofia
- Department Name
- Rheumatology
- Principal Investigator Name
- Clementina López Medina
- Principal Investigator Email
- clementinalopezmedina@gmail.com
- Contact Person Name
- Clementina López Medina
- Contact Person Email
- clementinalopezmedina@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
Poland
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 327
- Number Of Sites
- 18
- Number Of Participants
- 182
Sites
- 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 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
- 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
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Mariusz Korkosz
- Principal Investigator Email
- kontakt@pratia.com
- Contact Person Name
- Mariusz Korkosz
- Contact Person Email
- kontakt@pratia.com
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
- Principal Investigator Name
- Rafal Wojciechowski
- Principal Investigator Email
- reumatologia@biziel.pl
- Contact Person Name
- Rafal Wojciechowski
- Contact Person Email
- reumatologia@biziel.pl
- 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@medicover.com
- Contact Person Name
- Slawomir Jeka
- Contact Person Email
- idalia.lewandowska@medicover.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
- 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
- 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
- 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
Romania
- Earliest CTIS Part Ii Submission Date
- 19-03-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 369
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Ecomed Research S.R.L.
- Principal Investigator Name
- Ananu-Florentin Vreju
- Principal Investigator Email
- ecomedresearch@gmail.com
- Contact Person Name
- Ananu-Florentin Vreju
- Contact Person Email
- ecomedresearch@gmail.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Camelia Maricica Nita
- Principal Investigator Email
- camelia.nita@yahoo.com
- Contact Person Name
- Camelia Maricica Nita
- Contact Person Email
- camelia.nita@yahoo.com
- Site Name
- Medaudio-Optica S.R.L.
- Department Name
- Rheumatology
- Principal Investigator Name
- Razvan Constantin Ionitescu
- Principal Investigator Email
- contact@medart.ro
- Contact Person Name
- Razvan Constantin Ionitescu
- Contact Person Email
- contact@medart.ro
- Site Name
- Delta Health Care S.R.L.
- Principal Investigator Name
- Bogdan Horia Chicos
- Principal Investigator Email
- studii.clinice@reginamaria.ro
- Contact Person Name
- Bogdan Horia Chicos
- Contact Person Email
- studii.clinice@reginamaria.ro
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-03-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 341
- Number Of Sites
- 12
- Number Of Participants
- 38
Sites
- 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
- Qualiclinic Kft.
- Principal Investigator Name
- Istvan Szombati
- Principal Investigator Email
- i.szombati@qclinic.hu
- Contact Person Name
- Istvan Szombati
- Contact Person Email
- i.szombati@qclinic.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
- 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
- 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
- Viktoria Csonka
- Principal Investigator Email
- viktoria.csonka@oec.hu
- Contact Person Name
- Viktoria Csonka
- Contact Person Email
- viktoria.csonka@oec.hu
- 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
- Bacs-Kiskun Varmegyei Oktatokorhaz
- Department Name
- Department of Rheumatology
- Principal Investigator Name
- Katalin Torocsik
- Principal Investigator Email
- torkatalin@hotmail.com
- Contact Person Name
- Katalin Torocsik
- Contact Person Email
- torkatalin@hotmail.com
- 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
- 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
- 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
- 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
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 duties code: 3 (role as provided in sponsor third-party entry)
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Sponsor duties codes: 6, 7 (roles as provided in sponsor third-party entry)
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Kit production (and other duties indicated by codes 4,5,6,8)
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sponsor duties codes: 15 (Kit production), 4, 5, 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Sponsor duties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duties codes: 6, 7","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
- Starting Dose
- 200 mg
- Dose Levels
- 200 mg | 400 mg
- Maximum Dose
- 400 mg
- Investigational Product Name
- JNJ-77242113-AAC Placebo tablet
- Modality
- Other
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