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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
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. Latha Naik Medical Professional Corporation /ID# 272803
Coordinator of this site? Confirm its status
SaskatoonCanadaRecruiting
Centre de Recherche Musculo-Squelettique /ID# 274397
Coordinator of this site? Confirm its status
Trois-RivièresCanadaRecruiting
Revmatologie /ID# 272367
Coordinator of this site? Confirm its status
BrnoCzechiaRecruiting
L.K.N. Arthrocentrum /ID# 272366
Coordinator of this site? Confirm its status
HlučínCzechiaRecruiting
Medical Plus s.r.o. /ID# 272363
Coordinator of this site? Confirm its status
Uherské HradištěCzechiaRecruiting
PV Medical Services s.r.o. /ID# 272368
Coordinator of this site? Confirm its status
ZlínCzechiaRecruiting
CHU Bordeaux - Hopital Pellegrin /ID# 273390
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Infirmerie Protestante De Lyon /ID# 273731
Coordinator of this site? Confirm its status
Caluire-et-CuireFranceRecruiting
Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762
Coordinator of this site? Confirm its status
Chambray-lès-ToursFranceRecruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877
Coordinator of this site? Confirm its status
OrléansFranceRecruiting
Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572
Coordinator of this site? Confirm its status
MiskolcHungaryRecruiting
Complex Rendelo Med Zrt. /ID# 272570
Coordinator of this site? Confirm its status
SzékesfehérvárHungaryRecruiting
Vital-Medicina Kft. /ID# 272855
Coordinator of this site? Confirm its status
VeszprémHungaryRecruiting
Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304
Coordinator of this site? Confirm its status
BialystokPolandRecruiting
Mics Centrum Medyczne Bydgoszcz /ID# 273297
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306
Coordinator of this site? Confirm its status
ElblagPolandRecruiting
MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305
Coordinator of this site? Confirm its status
PruszkówPolandRecruiting
Centrum Medyczne Reuma Park /ID# 273301
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Tekton Research - West Gate /ID# 272765
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085
Coordinator of this site? Confirm its status
Avon ParkUnited StatesRecruiting
Clinical Research Of West Florida - Phase I Unit /ID# 273198
Coordinator of this site? Confirm its status
ClearwaterUnited StatesRecruiting
Altoona Center For Clinical Research /ID# 272593
Coordinator of this site? Confirm its status
DuncansvilleUnited StatesRecruiting
Klein And Associates /ID# 272829
Coordinator of this site? Confirm its status
HagerstownUnited StatesCompleted
Accurate Clinical Research - Houston /ID# 272754
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Newport Huntington Medical Group /ID# 272764
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesRecruiting
Private Practice - Dr. Ramesh C. Gupta I /ID# 272897
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting
Paramount Medical Research and Consulting /ID# 272757
Coordinator of this site? Confirm its status
Middleburg HeightsUnited StatesRecruiting
HMD Research LLC /ID# 273086
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Tekton Research, LLC /ID# 272901
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879
Coordinator of this site? Confirm its status
SkokieUnited StatesRecruiting
West Broward Rheumatology Associates /ID# 272892
Coordinator of this site? Confirm its status
TamaracUnited StatesRecruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Dynamed Clinical Research - Tomball /ID# 272760
Coordinator of this site? Confirm its status
TomballUnited StatesRecruiting
Willow Rheumatology and Wellness, PLLC /ID# 277354
Coordinator of this site? Confirm its status
WillowbrookUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.