Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
Recruiting · NCT06865105 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
37 locations listed across 8 US states.
- 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
- Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195 - Budapest, Hungary
- Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857 - Budapest, Hungary
- Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877 - Orléans, France
- 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
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572 - Miskolc, Borsod-Abauj Zemplen county, Hungary
- Revmatologie /ID# 272367 - Brno, Brno-mesto, Czechia
- Complex Rendelo Med Zrt. /ID# 272570 - Székesfehérvár, Fejér, Hungary
- Vital-Medicina Kft. /ID# 272855 - Veszprém, Fejér, Hungary
- Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762 - Chambray-lès-Tours, Indre-et-Loire, France
- 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
- L.K.N. Arthrocentrum /ID# 272366 - Hlučín, Moravian-Silesian Region, Czechia
- CHU Bordeaux - Hopital Pellegrin /ID# 273390 - Bordeaux, New Aquitaine, France
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304 - Bialystok, Podlaskie Voivodeship, Poland
- Centre de Recherche Musculo-Squelettique /ID# 274397 - Trois-Rivières, Quebec, Canada
- Dr. Latha Naik Medical Professional Corporation /ID# 272803 - Saskatoon, Saskatchewan, Canada
- Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306 - Elblag, Warmian-Masurian Voivodeship, Poland