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Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
NCT06865105 · AbbVie
In plain English
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Official title
A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
About this study
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 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).
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-11
Estimated completion: 2028-01
Last updated: 2025-12-18
Interventions
Drug: LutikizumabDrug: Risankizumab
Primary outcomes
- • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response (At Week 16)
- • Number of Participants With Adverse Events (AEs) (Up to Week 52)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (37)
Newport Huntington Medical Group /ID# 272764Recruiting
Huntington Beach, California, United States
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085Recruiting
Avon Park, Florida, United States
Clinical Research Of West Florida - Phase I Unit /ID# 273198Recruiting
Clearwater, Florida, United States
HMD Research LLC /ID# 273086Recruiting
Orlando, Florida, United States
West Broward Rheumatology Associates /ID# 272892Recruiting
Tamarac, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199Recruiting
Tampa, Florida, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879Recruiting
Skokie, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 277354Recruiting
Willowbrook, Illinois, United States
Klein And Associates /ID# 272829Completed
Hagerstown, Maryland, United States
Paramount Medical Research and Consulting /ID# 272757Recruiting
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research /ID# 272593Recruiting
Duncansville, Pennsylvania, United States
Private Practice - Dr. Ramesh C. Gupta I /ID# 272897Recruiting
Memphis, Tennessee, United States
Tekton Research - West Gate /ID# 272765Recruiting
Austin, Texas, United States
Accurate Clinical Research - Houston /ID# 272754Recruiting
Houston, Texas, United States
Tekton Research, LLC /ID# 272901Recruiting
San Antonio, Texas, United States
Dynamed Clinical Research - Tomball /ID# 272760Recruiting
Tomball, Texas, United States
Centre de Recherche Musculo-Squelettique /ID# 274397Recruiting
Trois-Rivières, Quebec, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 272803Recruiting
Saskatoon, Saskatchewan, Canada
Revmatologie /ID# 272367Recruiting
Brno, Brno-mesto, Czechia
L.K.N. Arthrocentrum /ID# 272366Recruiting
Hlučín, Moravian-Silesian Region, Czechia
Medical Plus s.r.o. /ID# 272363Recruiting
Uherské Hradiště, Czechia
PV Medical Services s.r.o. /ID# 272368Recruiting
Zlín, Czechia
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771Recruiting
Nice, Alpes-Maritimes, France
Infirmerie Protestante De Lyon /ID# 273731Recruiting
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762Recruiting
Chambray-lès-Tours, Indre-et-Loire, France
CHU Bordeaux - Hopital Pellegrin /ID# 273390Recruiting
Bordeaux, New Aquitaine, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877Recruiting
Orléans, France
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572Recruiting
Miskolc, Borsod-Abauj Zemplen county, Hungary
Complex Rendelo Med Zrt. /ID# 272570Recruiting
Székesfehérvár, Fejér, Hungary
Vital-Medicina Kft. /ID# 272855Recruiting
Veszprém, Fejér, Hungary
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195Recruiting
Budapest, Hungary
Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857Recruiting
Budapest, Hungary
Mics Centrum Medyczne Bydgoszcz /ID# 273297Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305Recruiting
Pruszków, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 273301Recruiting
Warsaw, Masovian Voivodeship, Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304Recruiting
Bialystok, Podlaskie Voivodeship, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306Recruiting
Elblag, Warmian-Masurian Voivodeship, Poland