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NCT06865105PHASE2Recruiting

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

AbbVie

Start Date

4/11/2025

Completion Date

1/1/2028

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

Age Range: 18 years to No maximum

Inclusion Criteria: * Participant is willing and able to comply with procedures required in the Master Protocol and substudies. * Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for 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 66 joint 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 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA Exclusion Criteria: * Participants who have had major surgery performed within 12 weeks prior to randomization 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 with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB) * Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO. * History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Interventions

DRUG

Lutikizumab

DRUG

Risankizumab

Interested in This Trial?

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Conditions

Psoriatic Arthritis

Locations

Newport Huntington Medical Group /ID# 272764

Huntington Beach, California 92648-5994

United States

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

Avon Park, Florida 33825

United States

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

Clearwater, Florida 33765

United States

HMD Research LLC /ID# 273086

Orlando, Florida 32819

United States

West Broward Rheumatology Associates /ID# 272892

Tamarac, Florida 33321

United States

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

Tampa, Florida 33606

United States

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

Skokie, Illinois 60076

United States

Willow Rheumatology and Wellness, PLLC /ID# 277354

Willowbrook, Illinois 60527

United States

Klein And Associates /ID# 272829

Hagerstown, Maryland 21740

United States

Paramount Medical Research and Consulting /ID# 272757

Middleburg Heights, Ohio 44130

United States

Altoona Center For Clinical Research /ID# 272593

Duncansville, Pennsylvania 16635

United States

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

Memphis, Tennessee 38119

United States

Tekton Research - West Gate /ID# 272765

Austin, Texas 78745

United States

Accurate Clinical Research - Houston /ID# 272754

Houston, Texas 77089-6142

United States

Tekton Research, LLC /ID# 272901

San Antonio, Texas 78251

United States

Dynamed Clinical Research - Tomball /ID# 272760

Tomball, Texas 77375

United States

Centre de Recherche Musculo-Squelettique /ID# 274397

Trois-Rivières, Quebec G9A 3X2

Canada

Dr. Latha Naik Medical Professional Corporation /ID# 272803

Saskatoon, Saskatchewan S7H 0P4

Canada

Revmatologie /ID# 272367

Brno, Brno-mesto 638 00

Czechia

L.K.N. Arthrocentrum /ID# 272366

Hlučín, Moravian-Silesian Region 748 01

Czechia

Medical Plus s.r.o. /ID# 272363

Uherské Hradiště, 686 01

Czechia

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

Zlín, 760 01

Czechia

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

Nice, Alpes-Maritimes 06001

France

Infirmerie Protestante De Lyon /ID# 273731

Caluire-et-Cuire, Auvergne-Rhône-Alpes 69300

France

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

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

France

CHU Bordeaux - Hopital Pellegrin /ID# 273390

Bordeaux, New Aquitaine 33076

France

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

Orléans, 45067

France

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

Miskolc, Borsod-Abauj Zemplen county 3529

Hungary

Complex Rendelo Med Zrt. /ID# 272570

Székesfehérvár, Fejér 8000

Hungary

Vital-Medicina Kft. /ID# 272855

Veszprém, Fejér 8200

Hungary

Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195

Budapest, 1023

Hungary

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

Budapest, 1027

Hungary

Mics Centrum Medyczne Bydgoszcz /ID# 273297

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-068

Poland

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

Pruszków, Masovian Voivodeship 05-800

Poland

Centrum Medyczne Reuma Park /ID# 273301

Warsaw, Masovian Voivodeship 02-665

Poland

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

Bialystok, Podlaskie Voivodeship 15-351

Poland

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

Elblag, Warmian-Masurian Voivodeship 82-300

Poland