Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

Официальное название

A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis

Обзор

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.

Вмешательства

• Препарат Lutikizumab
  Subcutaneous (SC) Injection
• Препарат Risankizumab
  Subcutaneous (SC) Injection

Первичные конечные точки

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [Срок оценки: At Week 16]
• Number of Participants With Adverse Events (AEs) [Срок оценки: Up to Week 52]

Вторичные конечные точки (4)

• Percentage of Participants Achieving Minimal Disease Activity (MDA) Response [Срок оценки: At Week 16]
• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [Срок оценки: At Week 16]
• Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response [Срок оценки: 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) [Срок оценки: At Week 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 16 центров

• 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
• … и ещё 8 центров

Франция · 5 центров

• 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

Венгрия · 5 центров

• 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

Польша · 5 центров

• 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

Чехия · 4 центра

• 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

Канада · 2 центра

• Centre de Recherche Musculo-Squelettique /ID# 274397 — Trois-Rivières
• Dr. Latha Naik Medical Professional Corporation /ID# 272803 — Saskatoon

Идентификаторы

NCT: NCT06865105 · M25-191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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