Clinical trial • Phase II • Immunology

JNJ-88545223 for Active psoriatic arthritis|Psoriatic arthritis

Phase II trial of JNJ-88545223 for Active psoriatic arthritis|Psoriatic arthritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Active psoriatic arthritis|Psoriatic arthritis
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-11-2025
First CTIS Authorization Date
20-03-2026

Trial design

Randomised, jnj-88545223 placebo (placebo comparator); dose/schedule not specified-controlled Phase II trial in Czechia, Germany, Hungary and others.

Randomised
Yes
Comparator
JNJ-88545223 Placebo (placebo comparator); dose/schedule not specified
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
74

Eligibility

Recruits 74 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18 years) and provide informed consent; no assent/parental consent process is described in the public CTIS data..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be adults (≥18 years) and provide informed consent; no assent/parental consent process is described in the public CTIS data.

Inclusion criteria

  • {"criterion_text":"- 1.\tAt the time of informed consent, be ≥18 years of age.\n- 2.\tHave a diagnosis of PsA for ≥3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening.\n- 3.\tHave active APs as defined by: At least 3 swollen joints and 3 tender joints at screening and at baseline (Week 0/Day 1); and CRP ≥0.1 mg/dL at screening ≥0.1 mg/dL\n- 4.\tHave active plaque psoriasis, with ≥1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis\n- 5.\tHave active PsA despite current or previous use of ≥1 of the following: a.\tConventional DMARDs Conventional DMARD (limited to MTX, SSZ, HCQ, and/or LEF) therapy is defined as taking a conventional DMARD for ≥12 weeks before first administration of study intervention, or evidence of conventional DMARD intolerance. b.\tApremilast Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for ≥12 weeks before first administration of study intervention, or evidence of apremilast intolerance. c.\tAnti-TNF agents Must have experienced either: i.\tInadequate response to TNFi treatment at an approved dose, as assessed by the treating physician, after ≥12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) or ≥14 weeks of infliximab (or biosimilar); OR ii.\tStopped TNFi treatment due to safety/tolerability reasons, as assessed by the treating physician. Limited to prior use of up to 2 different TNFi\n- 6.\tIf currently using conventional DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment ≥12 weeks and the dose must be stable for ≥4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the conventional DMARD. If currently not using MTX, SSZ, or HCQ, must have been off such medication(s) for at least 4 weeks before first the administration of study intervention. If currently not using LEF, must have been off this medication for at least 12 weeks before the first administration of study intervention. a.\tIf using MTX, the route of administration and dose must be stable at ≤25 mg/week b.\tIf receiving SSZ, the dose must be stable at ≤3 g/day c.\tIf receiving HCQ, the dose must be stable at ≤400 mg/day d.\tIf receiving LEF, the dose must be stable at ≤20 mg/day\n- 7.\tIf using apremilast at baseline (Week 0/Day 1), participants must be on a stable dose at ≤30 mg twice daily for ≥12 weeks before first administration of study intervention. If currently not using apremilast, must have been off this medication for at least 4 weeks before the first administration of study intervention.\n- 8.\tIf using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for ≥2 weeks before first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must have been off such medication(s) for at least 2 weeks before first administration of study intervention.\n- 9.\tIf using oral corticosteroids at baseline (Week 0/Day 1), participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for ≥2 weeks before first administration of study intervention. If currently not using oral corticosteroids, must have been off such medication(s) for at least 2 weeks before the first administration of study intervention"}

Exclusion criteria

  • {"criterion_text":"- 1.\tHas a history or current signs and symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except PsA), psychiatric, genitourinary, and/or metabolic disturbances.\n- 2.\tCurrently 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 ≥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 ≥12 weeks prior to the first study intervention administration).\n- 3.\tHas other inflammatory diseases that might confound the evaluations of benefit of JNJ 88545223 therapy\n- 4.\tHave rheumatoid factor or anti-CCP antibody levels at screening that are above the ULN\n- 5.\tActive hepatitis of infectious origin\n- 6.\tHistory of chronic or recurrent infectious disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- ACR50 response at Week 16.","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
74
Recruitment Window Months
15
Consent Approach
Informed consent obtained from adult participants (≥18 years). Country-specific Subject Information Sheet and Informed Consent Form (SIS/ICF) documents are available (examples: DE, ES, HU, CZ, PL and multi-country English versions). Optional genetic consent and Pregnant Partner information forms are included in country-specific ICF document sets.

Methods

  • Recruitment arrangements (K1) documents submitted per country (Czechia, Germany, Hungary, Spain, Poland) - country-specific recruitment arrangements files present.
  • Flyer (patient-facing) - documents present for Germany (DE), Hungary (HU), Spain (ES).
  • Patient recruitment brochure - documents present for Germany (DE), Hungary (HU), Spain (ES).
  • Patient Email outreach - document present for Germany (DE).
  • Social Media - document present for Germany (DE).

Geography

Total Number Of Sites
42
Total Number Of Participants
160

Czechia

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
18
Number Of Sites
6
Number Of Participants
28

Sites

Site Name
Revimex pro s.r.o.
Department Name
Revmatologická ambulance
Contact Person Name
Gabriela Stolarz
Contact Person Email
revimex@email.cz
Site Name
MEDICAL PLUS Research s.r.o.
Department Name
Revmatologická a osteologická ambulance
Contact Person Name
Eva Dokoupilová
Contact Person Email
evadokoupil@gmail.com
Site Name
Clintrial s.r.o.
Contact Person Name
Vlasta Gollerová
Contact Person Email
info@clintrial.cz
Site Name
Pratia Pardubice a.s.
Contact Person Name
Marcela Svobodová
Contact Person Email
lukas.rocnak@ccrpardubice.com
Site Name
Rheuma s.r.o.
Contact Person Name
Jaroslava Spěváková
Contact Person Email
spevako.revma@seznam.cz
Site Name
L.K.N. Arthrocentrum s.r.o.
Contact Person Name
Libor Novosad
Contact Person Email
libor.novosad@email.cz

Germany

Earliest CTIS Part Ii Submission Date
25-02-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
23
Number Of Sites
9
Number Of Participants
31

Sites

Site Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Department Name
Hamburger Rheuma Forschungszentrum II/ Dr. Andrea Everding GmbH GbR
Contact Person Name
Andrea Everding
Contact Person Email
everding@hotmail.de
Site Name
Centrum für Angewandte Immunologie & Rheumatologie (CAIR)
Contact Person Name
Bernhard Heilig
Contact Person Email
heilig@cair-heidelberg.de
Site Name
Rheuma-Research Lausitz, Zentrum für klinische Studien
Contact Person Name
Mario Sutowicz
Contact Person Email
sutowicz@gmx.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Fachklinik Bad Bentheim, Klinisches Studienzentrum
Contact Person Name
Thomas Rath
Contact Person Email
t.rath@fk-bentheim.de
Site Name
Hautarztpraxis Dr Med Matthias Hoffmann
Contact Person Name
Matthias Hoffmann
Contact Person Email
drho@hautarzt-dr-hoffmann.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Department of Rheumatology and Clinical Immunology
Contact Person Name
David Simon
Contact Person Email
david.simon@charite.de
Site Name
BAG Dres. med. Quist PartG
Department Name
Gemeinschaftspraxis
Contact Person Name
Sven Quist
Contact Person Email
s.quist@dermatologie-quist.de
Site Name
Rheumatologische Schwerpunktpraxis
Department Name
Rheumatologische Schwerpunktpraxis im Ärztehaus am Walter-Schreiber-Platz
Contact Person Name
Jan Brandt-Jürgens
Contact Person Email
jan.brandt-juergens@charite.de
Site Name
Hautarztpraxis Mortazawi GbR
Contact Person Name
Dariusch Mortazwai
Contact Person Email
mortazawi@gmx.de

Hungary

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
34
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Qualiclinic Kft.
Contact Person Name
Szombati István
Contact Person Email
i.szombati@qclinic.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Pandy Kalman Tagkorhaz
Contact Person Name
Keszthelyi Péter
Contact Person Email
keszthelyi.peter@bmkk.eu
Site Name
Complex Rendelo Med Zrt.
Contact Person Name
Kerekes Kata
Contact Person Email
drkerekeskata@yahoo.com
Site Name
Semmelweis University
Department Name
Reumatológiai és Immunológiai Klinika
Contact Person Name
Vereckei Edit
Contact Person Email
drvereckei@gmail.com
Site Name
Vasarhelyi Sarkanyfu Kft.
Contact Person Name
Balázs Éva
Contact Person Email
jimbies@gmail.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Tatár Gyöngyi
Contact Person Email
reuma@hotmail.hu
Site Name
Vital-Medicina Kft.
Contact Person Name
Drescher Edit
Contact Person Email
dr.dreschere@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
27
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Rheumatology
Contact Person Name
Jose Javier Perez Venegas
Contact Person Email
perez.venegas@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Rheumatology
Contact Person Name
Eva Perez Pampin
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Rheumatology
Contact Person Name
Nadia Abdel-Kader Martin
Contact Person Email
abdelmartin@hotmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Rheumatology
Contact Person Name
Francisco Javier Blanco Garcia
Contact Person Email
fblagar@sergas.es
Site Name
Accellacare Espana S.L.
Department Name
Rheumatology
Contact Person Name
Raul Veiga Cabello
Contact Person Email
grupo9123@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Rheumatology
Contact Person Name
Elena Alonso Blanco-Morales
Contact Person Email
elenaabm@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
29
Number Of Sites
14
Number Of Participants
65

Sites

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
Futuremeds Sp. z o.o.
Department Name
FutureMeds Targowek
Contact Person Name
Agnieszka Jurek-Urbanowska
Site Name
ETG Lublin Sp. z o.o.
Department Name
ETG Lublin
Contact Person Name
Katarzyna Zelazowska
Contact Person Email
k.zelazowska@etg-network.com
Site Name
Pratia S.A.
Department Name
Pratia MCM Krakow​
Contact Person Name
Piotr Gluszko
Contact Person Email
piotr.gluszko@pratia.pl
Site Name
Rheuma Medicus Sp. z o.o.
Contact Person Name
Marta Soltysik-Wysmolek
Contact Person Email
marta.wysmolek@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
FutureMeds Targowek
Contact Person Name
Agnieszka Zielinska
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Torun
Contact Person Name
Slawomir Jeka
Contact Person Email
s.jeka@wp.plm
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Contact Person Name
Magdalena Krajewska-Wlodarczyk
Site Name
Malopolskie Badania Kliniczne Sp. z o.o.
Contact Person Name
Bogdan Batko
Contact Person Email
b.batko@mbk.clinic
Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park​
Contact Person Name
Ewa Matyska-Piekarska
Contact Person Email
ewamatyska@wp.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej​
Contact Person Name
Rafal Wojciechowski
Contact Person Email
r.wojciechowski@wp.eu
Site Name
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Contact Person Name
Artur Racewicz
Contact Person Email
artur.racewicz@gmail.com
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Warszawa​
Contact Person Name
Malgorzata Gryka-Marton
Site Name
NZOZ Lecznica Mak Med s.c.
Contact Person Name
Marek Krogulec
Contact Person Email
marekkrogulec@wp.pl

Sponsor

Primary sponsor

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

Contract research organisations

Name
Labcorp Central Laboratory Services SARL
Responsibilities
sponsorDuties code: 4
Name
4g Clinical LLC
Responsibilities
sponsorDuties code: 3
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: 15 (ECG), 7

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 15 (ECG), 7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-88545223
Active Substance
JNJ-88545223
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
JNJ-88545223
Active Substance
JNJ-88545223
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
JNJ-88545223 Placebo
Modality
Other

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