Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Last updated: December 16, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Psoriatic Arthritis

Joint Injuries

Treatment

Lutikizumab

Risankizumab

Clinical Study ID

NCT06865105
M25-191
  • Ages > 18
  • All Genders

Study Summary

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.

The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is willing and able to comply with procedures required in the MasterProtocol and substudies.

  • Participant has a documented clinical diagnosis of PsA with symptom onset at least 6months prior to the Screening Visit and fulfillment of the Classification Criteriafor Psoriatic Arthritis (CASPAR) at Screening Visit.

  • Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66joint count) at both the Screening Visit and Baseline.

  • Participant has active plaque PsO and/or a documented history of plaque PsO.

  • Participant must demonstrate intolerance or inadequate response to 1 to 2 targetedtherapies (biologic or targeted synthetic disease-modifying antirheumatic drugs)approved for the treatment of PsA

Exclusion

Exclusion Criteria:

  • Participants who have had major surgery performed within 12 weeks prior torandomization or plan to have a major surgery during conduct of the study (e.g.,aneurysm removal, stomach ligation).

  • Participants with the following chronic or active infections: Are infected withhuman immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis Cvirus(HCV) infection, active tuberculosis(TB)

  • Active skin disease other than psoriasis (PsO) which could interfere with theassessment of PsO.

  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or currentdiagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissuediseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Lutikizumab
Phase: 2
Study Start date:
April 11, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • Centre de Recherche Musculo-Squelettique /ID# 274397

    Trois-Rivieres, Quebec G9A 3X2
    Canada

    Site Not Available

  • Centre de Recherche Musculo-Squelettique /ID# 274397

    Trois-Rivières 6169141, Quebec 6115047 G9A 3X2
    Canada

    Active - Recruiting

  • Dr. Latha Naik Medical Professional Corporation /ID# 272803

    Saskatoon, Saskatchewan S7H 0P4
    Canada

    Site Not Available

  • Dr. Latha Naik Medical Professional Corporation /ID# 272803

    Saskatoon 6141256, Saskatchewan 6141242 S7H 0P4
    Canada

    Active - Recruiting

  • Revmatologie /ID# 272367

    Brno, Brno-mesto 638 00
    Czechia

    Site Not Available

  • Revmatologie /ID# 272367

    Brno 3078610, Brno-mesto 638 00
    Czechia

    Active - Recruiting

  • L.K.N. Arthrocentrum /ID# 272366

    Hlučín 3075716, Moravskoslezský kraj 3339573 748 01
    Czechia

    Active - Recruiting

  • Medical Plus s.r.o. /ID# 272363

    Uherske Hradiste, 686 01
    Czechia

    Site Not Available

  • Medical Plus s.r.o. /ID# 272363

    Uherské Hradiště 3063739, 686 01
    Czechia

    Active - Recruiting

  • PV Medical Services s.r.o. /ID# 272368

    Zlin, 760 01
    Czechia

    Site Not Available

  • PV Medical Services s.r.o. /ID# 272368

    Zlín 3061370, 760 01
    Czechia

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771

    Nice 2990440, Alpes-Maritimes 06001
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 272771

    Nice 2990440, Alpes-Maritimes 06001
    France

    Active - Recruiting

  • Infirmerie Protestante De Lyon /ID# 273731

    Caluire-et-Cuire, Auvergne-Rhone-Alpes 69300
    France

    Site Not Available

  • Infirmerie Protestante De Lyon /ID# 273731

    Caluire-et-Cuire 3029096, Auvergne-Rhône-Alpes 11071625 69300
    France

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762

    Chambray-lès-Tours 3027343, Indre-et-Loire 37170
    France

    Active - Recruiting

  • CHU Bordeaux - Hopital Pellegrin /ID# 273390

    Bordeaux 3031582, Nouvelle-Aquitaine 11071620 33076
    France

    Active - Recruiting

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877

    Orléans 2989317, 45067
    France

    Active - Recruiting

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572

    Miskolc 717582, Borsod-Abauj Zemplen county 722064 3529
    Hungary

    Active - Recruiting

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572

    Miskolc, Borsod-Abauj-Zemplen 3529
    Hungary

    Site Not Available

  • Complex Rendelo Med Zrt. /ID# 272570

    Székesfehérvár, Fejer 8000
    Hungary

    Site Not Available

  • Complex Rendelo Med Zrt. /ID# 272570

    Székesfehérvár 3044774, Fejér 3053028 8000
    Hungary

    Active - Recruiting

  • Vital-Medicina Kft. /ID# 272855

    Veszprém, Fejér 3053028 8200
    Hungary

    Active - Recruiting

  • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857

    Budapest 3054643, 1027
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195

    Budapest 3054643, 1023
    Hungary

    Active - Recruiting

  • Mics Centrum Medyczne Bydgoszcz /ID# 273297

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-068
    Poland

    Active - Recruiting

  • MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305

    Grodzisk Mazowiecki 771401, Masovian Voivodeship 858787 05-825
    Poland

    Site Not Available

  • MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305

    Pruszków 761228, Masovian Voivodeship 858787 05-800
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park /ID# 273301

    Warsaw 756135, Masovian Voivodeship 858787 02-665
    Poland

    Active - Recruiting

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304

    Bialystok 776069, Podlaskie Voivodeship 858789 15-351
    Poland

    Active - Recruiting

  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306

    Elblag 3099759, Warmian-Masurian Voivodeship 858791 82-300
    Poland

    Active - Recruiting

  • Newport Huntington Medical Group /ID# 272764

    Huntington Beach, California 92648-5994
    United States

    Site Not Available

  • Newport Huntington Medical Group /ID# 272764

    Huntington Beach 5358705, California 5332921 92648-5994
    United States

    Active - Recruiting

  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085

    Avon Park, Florida 33825
    United States

    Site Not Available

  • Clinical Research Of West Florida - Phase I Unit /ID# 273198

    Clearwater, Florida 33765
    United States

    Site Not Available

  • HMD Research LLC /ID# 273086

    Orlando, Florida 32819
    United States

    Site Not Available

  • West Broward Rheumatology Associates /ID# 272892

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199

    Tampa, Florida 33606
    United States

    Site Not Available

  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085

    Avon Park 4146440, Florida 4155751 33825
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Phase I Unit /ID# 273198

    Clearwater 4151316, Florida 4155751 33765
    United States

    Active - Recruiting

  • HMD Research LLC /ID# 273086

    Orlando 4167147, Florida 4155751 32819
    United States

    Active - Recruiting

  • West Broward Rheumatology Associates /ID# 272892

    Tamarac 4174738, Florida 4155751 33321
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879

    Skokie 4911600, Illinois 4896861 60076
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness, PLLC /ID# 277354

    Willowbrook 4916709, Illinois 4896861 60527
    United States

    Active - Recruiting

  • Klein And Associates /ID# 272829

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Klein And Associates /ID# 272829

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Completed

  • Paramount Medical Research and Consulting /ID# 272757

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Paramount Medical Research and Consulting /ID# 272757

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research /ID# 272593

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Altoona Center For Clinical Research /ID# 272593

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Active - Recruiting

  • Dr. Ramesh Gupta /ID# 272897

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Dr. Ramesh Gupta /ID# 272897

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

  • Private Practice - Dr. Ramesh C. Gupta I /ID# 272897

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

  • Tekton Research - West Gate /ID# 272765

    Austin, Texas 78745
    United States

    Site Not Available

  • Accurate Clinical Research - Houston /ID# 272754

    Houston, Texas 77089-6142
    United States

    Site Not Available

  • Tekton Research, LLC /ID# 272901

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Dynamed Clinical Research - Tomball /ID# 272760

    Tomball, Texas 77375
    United States

    Site Not Available

  • Tekton Research - West Gate /ID# 272765

    Austin 4671654, Texas 4736286 78745
    United States

    Active - Recruiting

  • Accurate Clinical Research - Houston /ID# 272754

    Houston 4699066, Texas 4736286 77089-6142
    United States

    Active - Recruiting

  • Tekton Research, LLC /ID# 272901

    San Antonio 4726206, Texas 4736286 78251
    United States

    Active - Recruiting

  • Dynamed Clinical Research - Tomball /ID# 272760

    Tomball 4737094, Texas 4736286 77375
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.