Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lutikizumab, Risankizumab.
- Who it may be relevant to
- Registry conditions: Psoriatic Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Czechia, France, Hungary +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Overview
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.
Interventions
- Drug Lutikizumab
Subcutaneous (SC) Injection - Drug Risankizumab
Subcutaneous (SC) Injection
Primary outcome measures
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [Time frame: At Week 16]
- Number of Participants With Adverse Events (AEs) [Time frame: Up to Week 52]
Secondary outcome measures (4)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) Response [Time frame: At Week 16]
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [Time frame: At Week 16]
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [Time frame: At Week 16]
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline) [Time frame: At Week 16]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Newport Huntington Medical Group /ID# 272764 — Huntington Beach
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 — Avon Park
- Clinical Research Of West Florida - Phase I Unit /ID# 273198 — Clearwater
- HMD Research LLC /ID# 273086 — Orlando
- West Broward Rheumatology Associates /ID# 272892 — Tamarac
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 — Tampa
- Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 — Skokie
- Willow Rheumatology and Wellness, PLLC /ID# 277354 — Willowbrook
- … and 8 more centers
France · 5 centers
- Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771 — Nice
- Infirmerie Protestante De Lyon /ID# 273731 — Caluire-et-Cuire
- Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762 — Chambray-lès-Tours
- CHU Bordeaux - Hopital Pellegrin /ID# 273390 — Bordeaux
- Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877 — Orléans
Hungary · 5 centers
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572 — Miskolc
- Complex Rendelo Med Zrt. /ID# 272570 — Székesfehérvár
- Vital-Medicina Kft. /ID# 272855 — Veszprém
- Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195 — Budapest
- Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857 — Budapest
Poland · 5 centers
- Mics Centrum Medyczne Bydgoszcz /ID# 273297 — Bydgoszcz
- MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305 — Pruszków
- Centrum Medyczne Reuma Park /ID# 273301 — Warsaw
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304 — Bialystok
- Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 2733 — Elblag
Czechia · 4 centers
- Revmatologie /ID# 272367 — Brno
- L.K.N. Arthrocentrum /ID# 272366 — Hlučín
- Medical Plus s.r.o. /ID# 272363 — Uherské Hradiště
- PV Medical Services s.r.o. /ID# 272368 — Zlín
Canada · 2 centers
- Centre de Recherche Musculo-Squelettique /ID# 274397 — Trois-Rivières
- Dr. Latha Naik Medical Professional Corporation /ID# 272803 — Saskatoon
Identifiers
NCT: NCT06865105 · M25-191