Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
NCT ID: NCT06865105
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-04-11
2028-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sub-Study 1: Risankizumab Monotherapy
Participants will receive Risankizumab
Risankizumab
Subcutaneous (SC) Injection
Sub-Study 1: Lutikizumab Monotherapy
Participants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.
Lutikizumab
Subcutaneous (SC) Injection
SubStudy 1: Lutikizumab and Risankizumab Combination Therapy
Participants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.
Lutikizumab
Subcutaneous (SC) Injection
Risankizumab
Subcutaneous (SC) Injection
Interventions
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Lutikizumab
Subcutaneous (SC) Injection
Risankizumab
Subcutaneous (SC) Injection
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Newport Huntington Medical Group /ID# 272764
Huntington Beach, California, United States
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
Avon Park, Florida, United States
Clinical Research Of West Florida - Phase I Unit /ID# 273198
Clearwater, Florida, United States
HMD Research LLC /ID# 273086
Orlando, Florida, United States
West Broward Rheumatology Associates /ID# 272892
Tamarac, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
Tampa, Florida, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879
Skokie, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 277354
Willowbrook, Illinois, United States
Klein And Associates /ID# 272829
Hagerstown, Maryland, United States
Paramount Medical Research and Consulting /ID# 272757
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research /ID# 272593
Duncansville, Pennsylvania, United States
Private Practice - Dr. Ramesh C. Gupta I /ID# 272897
Memphis, Tennessee, United States
Tekton Research - West Gate /ID# 272765
Austin, Texas, United States
Accurate Clinical Research - Houston /ID# 272754
Houston, Texas, United States
Tekton Research, LLC /ID# 272901
San Antonio, Texas, United States
Dynamed Clinical Research - Tomball /ID# 272760
Tomball, Texas, United States
Centre de Recherche Musculo-Squelettique /ID# 274397
Trois-Rivières, Quebec, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 272803
Saskatoon, Saskatchewan, Canada
Revmatologie /ID# 272367
Brno, Brno-mesto, Czechia
L.K.N. Arthrocentrum /ID# 272366
Hlučín, Moravskoslezský kraj, Czechia
Medical Plus s.r.o. /ID# 272363
Uherské Hradiště, , Czechia
PV Medical Services s.r.o. /ID# 272368
Zlín, , Czechia
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771
Nice, Alpes-Maritimes, France
Infirmerie Protestante De Lyon /ID# 273731
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762
Chambray-lès-Tours, Indre-et-Loire, France
CHU Bordeaux - Hopital Pellegrin /ID# 273390
Bordeaux, Nouvelle-Aquitaine, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877
Orléans, , France
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572
Miskolc, Borsod-Abauj Zemplen county, Hungary
Complex Rendelo Med Zrt. /ID# 272570
Székesfehérvár, Fejér, Hungary
Vital-Medicina Kft. /ID# 272855
Veszprém, Fejér, Hungary
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195
Budapest, , Hungary
Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857
Budapest, , Hungary
Mics Centrum Medyczne Bydgoszcz /ID# 273297
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305
Pruszków, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 273301
Warsaw, Masovian Voivodeship, Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304
Bialystok, Podlaskie Voivodeship, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306
Elblag, Warmian-Masurian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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M25-191
Identifier Type: -
Identifier Source: org_study_id