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New drug shows promise in taming psoriatic arthritis flares

NCT ID NCT03158285

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested guselkumab, a drug given by injection, in 741 adults with active psoriatic arthritis. The goal was to see if it reduces joint pain and swelling. Participants received either guselkumab or a placebo. The main measure was a 20% improvement in arthritis symptoms at 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
guselkumab
What this could lead to
If successful, this could provide a new treatment option to control psoriatic arthritis symptoms and improve physical function.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Risks include potential side effects from the drug, and it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

741 people

The number who actually took part.

Started

Jul 2017

Finished

Nov 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (\>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory * 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 (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray \[single anterior-posterior view\] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented) * Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis * Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy Exclusion Criteria: * Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease * Has previously received any biologic treatment * Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor * Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent * Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate \[MTX\], sulfasalazine \[SSZ\], Hydroxychloroquine \[HCQ\], leflunomide \[LEF\]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent * Has received apremilast within 4 weeks prior to the first administration of study agent

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Conditions

The condition(s) this trial relates to.

psoriatic arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis, psoriatic

Contacts and locations

Locations

  • Akdeniz University Medical Faculty

    Antalya, 7059, Turkey (Türkiye)

  • Ankara Bilkent City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Arizona Arthritis & Rheumatology Associates PC

    Glendale, Arizona, 85306, United States

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210, United States

  • Arthritis Consultants

    St Louis, Missouri, 63141, United States

  • Austin Regional Clinic

    Austin, Texas, 78731-3146, United States

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147, Turkey (Türkiye)

  • Biogenes Sp z o o

    Wroclaw, 53 224, Poland

  • Central Outpatient Clinic

    Vilnius, LT01117, Lithuania

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546, Poland

  • Centrum Badawcze Wspolczesnej Terapii

    Lodz, 90-242, Poland

  • Centrum Kliniczno Badawcze

    Elblag, 82-300, Poland

  • Centrum Medyczne AMED Targowek

    Warsaw, 03 291, Poland

  • Centrum Medyczne AMED oddzial w Lodzi

    Lodz, 91 363, Poland

  • Centrum Medyczne Hetmanska

    Poznan, 60 218, Poland

  • Chang Gung Memorial Hospital Kaohsiung Branch

    Kaohsiung City, 833, Taiwan

  • Chang Kung Memorial Hospital

    Taipei, 105, Taiwan

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333, Taiwan

  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary

    Chelyabinsk, 454092, Russia

  • City Clinic №25 - City Rheumatology Centre

    Saint Petersburg, 190068, Russia

  • City Clinical Hospital No. 2

    Kryvyi Rih, 50056, Ukraine

  • Clinical Diagnostic Center 'Ultramed'

    Omsk, 644024, Russia

  • Clinical Emergency Hospital n.a. N.V. Solovyev

    Yaroslavl, 150003, Russia

  • Clinical Hospital #10

    Yaroslavl, 150023, Russia

  • Clinical Hospital #3

    Yaroslavl, 150007, Russia

  • Clinical Research Center of Connecticut

    Danbury, Connecticut, 06810, United States

  • Clinical Research Centre

    Tartu, 50106, Estonia

  • Communal Institution of Health Kharkiv City multifield hospital №18

    Kharkiv, 61029, Ukraine

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009, Ukraine

  • Danylo Haytsky Lviv National Medical University, Lviv Regional Clinical Hospital

    Lviv, 79010, Ukraine

  • Daugavpils Regional Hospital

    Daugavpils, LV5417, Latvia

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana, 46256-4697, United States

  • Derma Clinic Riga

    Riga, LV1003, Latvia

  • Diagnostic Consulting Center No 17

    Sofia, 1505, Bulgaria

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340, Turkey (Türkiye)

  • East Tallinn Central Hospital

    Tallinn, 11312, Estonia

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10 117, Poland

  • Family polyclinic #4

    Korolyov, 141060, Russia

  • H.U. Infanta Sofía

    San Sebastián de los Reyes, 28702, Spain

  • Hacettepe University Medical Faculty

    Ankara, 6100, Turkey (Türkiye)

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706, Spain

  • Hosp. Do Meixoeiro

    Vigo, 36214, Spain

  • Hosp. Infanta Luisa

    Seville, 41010, Spain

  • Hosp. Regional. Carlos Haya

    Málaga, 29009, Spain

  • Hosp. Univ. Dr. Peset

    Valencia, 46017, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. de Basurto

    Bilbao, 48013, Spain

  • Hosp. Univ. de Cruces

    Barakaldo, 48903, Spain

  • Hosp. Unv. de Valme

    Seville, 414014, Spain

  • Hosp. de Merida

    Mérida, 06800, Spain

  • Hospital Melaka

    Malacca, 75400, Malaysia

  • Hospital Putrajaya

    Putrajaya, 62250, Malaysia

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990, Malaysia

  • Hospital Selayang

    Batu Caves, 68100, Malaysia

  • Hospital Tuanku Jaafar

    Seremban, 70300, Malaysia

  • Hualien Tzu Chi Hospital

    Hualien City, 970, Taiwan

  • Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

    Ivano-Frankivsk, Ukraine

  • Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital

    Izmir, 35360, Turkey (Türkiye)

  • J Kisis Ltd

    Riga, LV1003, Latvia

  • Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'

    Kharkiv, 61029, Ukraine

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000, Ukraine

  • Krasnodar Clinical Dermatovenerologic Dispensary

    Krasnodar, 350020, Russia

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022, Russia

  • Kyiv City Clinical Hospital #3

    Kyiv, 02125, Ukraine

  • Kyiv Railway Station Clinical Hospital #2

    Kyiv, Ukraine

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107, Ukraine

  • Leningrad region clinical hospital

    Saint Petersburg, 194291, Russia

  • Lipetsk Regional Dermatovenerological Dispensary

    Lipetsk, 398005, Russia

  • Lubelskie Centrum Diagnostyczne

    Świdnik, 21 040, Poland

  • Lviv Communcal City Clinical Hospital #4

    Lviv, Ukraine

  • MHAT-Targovishte, AD

    Targovishte, 7700, Bulgaria

  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

    Uzhhorod, 88000, Ukraine

  • MUDr Rosypalova s r o

    Ostrava, 70800, Czechia

  • Marmara University Medical Faculty

    Istanbul, 34899, Turkey (Türkiye)

  • Medical Center 'Consylium Medical'

    Kyiv, 04050, Ukraine

  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

    Vinnytsia, 21009, Ukraine

  • Medical Center Teodora

    Rousse, 7003, Bulgaria

  • Medical Centre Maximum Health

    Kemerovo, 650066, Russia

  • Medical Centre Synexus

    Sofia, 1794, Bulgaria

  • Medical Plus S R O

    Uherské Hradiště, 68601, Czechia

  • Medical and Sanitary Unit ''Severstal''

    Cherepovets, 162600, Russia

  • Medycyna Kliniczna

    Warsaw, 00-874, Poland

  • Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

    Kherson, 73000, Ukraine

  • Military Medical Academy

    Sofia, 1606, Bulgaria

  • Moscow State Medical and Stomatological University

    Moscow, 111398, Russia

  • Multidisciplinary Medical Center of Odessa National Medical University

    Odesa, 65026, Ukraine

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4003, Bulgaria

  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

    Plovdiv, 4004, Bulgaria

  • Municipal Institution Regional hospital-center of emergency care and disasters medicine

    Kharkiv, Ukraine

  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

    Ternopil, Ukraine

  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

    Odesa, 65025, Ukraine

  • Municipal health care institution Chernihiv Regional Hospital

    Chernihiv, 14029, Ukraine

  • Municipal institution Central Clinical Hospital #1 Zhytomir

    Zhytomyr, 10002, Ukraine

  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil, 46002, Ukraine

  • NSZOZ Unica CR

    Dąbrówka, 62-069, Poland

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830, Poland

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warsaw, 02 637, Poland

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87-100, Poland

  • National Cheng Kung University Medical Center

    Tainan, 704, Taiwan

  • National Osteoporosis Centre

    Vilnius, LT09310, Lithuania

  • OU Innomedica

    Tallinn, 10117, Estonia

  • Orenburg State Medical University

    Orenburg, 460000, Russia

  • Orto Clinic Ltd

    Riga, LV1005, Latvia

  • Osmangazi University Medical Faculty

    Eskişehir, 26480, Turkey (Türkiye)

  • PV Medical S R O

    Zlín, 76001, Czechia

  • Parnu Hospital

    Pärnu, 80010, Estonia

  • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

    Poltava, Ukraine

  • Regional Clinical Hospital

    Tver', 170036, Russia

  • Regional Clinical Hospital for War Veterans

    Kemerovo, 650000, Russia

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005, Russia

  • Republican Hospital n.a.V.A.Baranov

    Petrozavodsk, 185019, Russia

  • Research Institute of Dermatovenerology, Immunology

    Yekaterinburg, 620076, Russia

  • Revmacentrum MUDr Mostera s r o

    Brno-Židenice, 615 00, Czechia

  • Revmaclinic

    Brno, 61141, Czechia

  • Revmatologicka ambulance

    Prague, 14000, Czechia

  • Revmatologicky institut

    Prague, 12850, Czechia

  • Rheumatology Associates

    Birmingham, Alabama, 35205, United States

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov-on-Don, 344007, Russia

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390046, Russia

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, Ukraine

  • Saratov Regional Clinical Hospital

    Saratov, 410053, Russia

  • Sarawak General Hospital

    Kuching, Sarawak, Malaysia

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, LT-76231, Lithuania

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025, Russia

  • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

    Kharkiv, 61039, Ukraine

  • Sumy State University

    Sumy, Ukraine

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85 168, Poland

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, 300053, Russia

  • Uludag University Medical Faculty

    Bursa, 16059, Turkey (Türkiye)

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

    Vinnytsia, Ukraine

  • Vakk, Jsc

    Kaunas, LT50128, Lithuania

  • Wro Medica

    Wroclaw, 51-685, Poland

  • Zaporizhzhya Regional Clinical Hospital

    Zaporizhzhya, Ukraine

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