Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)

Официальное название

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.

Обзор

Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

Подробное описание

This study consists of a 16-week Placebo-controlled Period and a 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-week Optional Extension.

Вмешательства

• Препарат Tulisokibart
  Subcutaneous administration
• Препарат Placebo
  Subcutaneous administration

Первичные конечные точки

• Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16 [Срок оценки: Week 16]

Вторичные конечные точки (5)

• Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16 [Срок оценки: Week 16]
• Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16 [Срок оценки: Week 16]
• Change from Baseline in HAQ-DI Score at Week 16 [Срок оценки: Baseline and Week 16]
• Number of Participants with ≥1 Adverse Event [Срок оценки: Up to approximately Week 142]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately Week 128]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.
• Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
• Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.
• Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.
• Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization.
• Has any active infection.
• Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 16 центров

• Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117) — Sun City
• Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120) — Tucson
• Medvin Clinical Research - Riverside ( Site 5115) — Riverside
• Cohen Medical Centers ( Site 5111) — Thousand Oaks
• Medvin Clinical Research - Tujunga ( Site 5113) — Tujunga
• Arthritis and Rheumatic Disease Specialties ( Site 5105) — Aventura
• International Center for Research ( Site 5124) — Tampa
• St. Luke's Clinic - Rheumatology - Boise ( Site 5109) — Boise
• … и ещё 8 центров

Украина · 7 центров

• Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Comp — Kiev
• Edelweiss Medics ( Site 7409) — Kyiv
• Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 741 — Kyiv
• Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 7410) — Lviv
• Limited liability company "Medical center Health Clinic" ( Site 7412) — Vinnytsia
• Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of — Vinnytsia
• Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 74 — Kyiv

Чили · 5 центров

• Centro de Estudios GyC ( Site 8206) — Santiago
• Enroll SpA ( Site 8203) — Santiago
• Clinica Dermacross ( Site 8200) — Santiago
• CECIM ( Site 8205) — Santiago
• Centro Internacional de Estudios Clinicos (CIEC) ( Site 8201) — Santiago

Польша · 5 центров

• MICS Centrum Medyczne Bydgoszcz ( Site 6907) — Bydgoszcz
• MICS Centrum Medyczne Torun ( Site 6903) — Torun
• Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901) — Lublin
• MICS Centrum Medyczne Warszawa ( Site 6905) — Warsaw
• Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartansk — Warsaw

Германия · 4 центра

• Rheuma-Research Lausitz ( Site 6409) — Cottbus
• Rheumazentrum Ruhrgebiet ( Site 6400) — Herne
• Rheumatologische Schwerpunktpraxis ( Site 6405) — Berlin
• HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin — Hamburg

Испания · 4 центра

• CHUS - Hospital Clinico Universitario ( Site 7102) — Santiago de Compostela
• Hospital Vall d' Hebron ( Site 7101) — Barcelona
• Hospital Viamed Santa Elena ( Site 7105) — Madrid
• Hospital Universitario la Fe ( Site 7107) — Valencia

Колумбия · 3 центра

• Clinica de la Costa S.A.S. ( Site 8301) — Barranquilla
• Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8 — Bogota
• Fundación Valle del Lili ( Site 8302) — Cali

Канада · 2 центра

• Centre Rhumatologie De L'Est ( Site 5201) — Rimouski
• Centre de Recherche Musculo-Squelettique ( Site 5202) — Trois-Rivières

Идентификаторы

NCT: NCT07486960 · 7240-015 · U1111-1318-4301 · 2025-520997-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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