NCT06865105RecruitingPhase 2
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 11 Apr 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- AbbVie
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT06865105
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 11 Apr 2025 to the primary completion date, Dec 2027
- 37 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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).
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Latha Naik Medical Professional Corporation /ID# 272803 Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
| Centre de Recherche Musculo-Squelettique /ID# 274397 Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Recruiting |
| Revmatologie /ID# 272367 Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| L.K.N. Arthrocentrum /ID# 272366 Coordinator of this site? Confirm its status | Hlučín | Czechia | Recruiting |
| Medical Plus s.r.o. /ID# 272363 Coordinator of this site? Confirm its status | Uherské Hradiště | Czechia | Recruiting |
| PV Medical Services s.r.o. /ID# 272368 Coordinator of this site? Confirm its status | Zlín | Czechia | Recruiting |
| CHU Bordeaux - Hopital Pellegrin /ID# 273390 Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Infirmerie Protestante De Lyon /ID# 273731 Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Recruiting |
| Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762 Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877 Coordinator of this site? Confirm its status | Orléans | France | Recruiting |
| Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857 Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195 Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572 Coordinator of this site? Confirm its status | Miskolc | Hungary | Recruiting |
| Complex Rendelo Med Zrt. /ID# 272570 Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Recruiting |
| Vital-Medicina Kft. /ID# 272855 Coordinator of this site? Confirm its status | Veszprém | Hungary | Recruiting |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304 Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Mics Centrum Medyczne Bydgoszcz /ID# 273297 Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306 Coordinator of this site? Confirm its status | Elblag | Poland | Recruiting |
| MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305 Coordinator of this site? Confirm its status | Pruszków | Poland | Recruiting |
| Centrum Medyczne Reuma Park /ID# 273301 Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Tekton Research - West Gate /ID# 272765 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 Coordinator of this site? Confirm its status | Avon Park | United States | Recruiting |
| Clinical Research Of West Florida - Phase I Unit /ID# 273198 Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| Altoona Center For Clinical Research /ID# 272593 Coordinator of this site? Confirm its status | Duncansville | United States | Recruiting |
| Klein And Associates /ID# 272829 Coordinator of this site? Confirm its status | Hagerstown | United States | Completed |
| Accurate Clinical Research - Houston /ID# 272754 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Newport Huntington Medical Group /ID# 272764 Coordinator of this site? Confirm its status | Huntington Beach | United States | Recruiting |
| Private Practice - Dr. Ramesh C. Gupta I /ID# 272897 Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Paramount Medical Research and Consulting /ID# 272757 Coordinator of this site? Confirm its status | Middleburg Heights | United States | Recruiting |
| HMD Research LLC /ID# 273086 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Tekton Research, LLC /ID# 272901 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 Coordinator of this site? Confirm its status | Skokie | United States | Recruiting |
| West Broward Rheumatology Associates /ID# 272892 Coordinator of this site? Confirm its status | Tamarac | United States | Recruiting |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Dynamed Clinical Research - Tomball /ID# 272760 Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| Willow Rheumatology and Wellness, PLLC /ID# 277354 Coordinator of this site? Confirm its status | Willowbrook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.