A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines

Официальное название

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)

Обзор

Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib over-encapsulated tablets.
• Препарат Active Comparator
  Active comparator capsule.
• Препарат Placebo
  Zasocitinib or active comparator matching placebo.

Первичные конечные точки

• Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]

Вторичные конечные точки (12)

• Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving ACR50 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Change From Baseline in the HAQ-DI Score at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving ACR70 Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: At Week 16]
• Change From Baseline in the Short Form-36 Health Survey Version 2.0 (SF-36 v2.0) Physical Component Summary (PCS) Score at Week 16 for Zasocitinib Dose A Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Score at Week 16 for Zasocitinib Dose A Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving ACR20 Response at Week 16 for Zasocitinib Dose A and B Compared to Active Comparator [Срок оценки: At Week 16]
• Percentage of Participants Achieving PASI-75 Response (in Participants With a Baseline >=3% BSA) at Week 16 for Zasocitinib Dose A compared to Active Comparator [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving LEI =0 (in Participants With a Baseline LEI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Change From Baseline in Individual Components of ACR Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]
• Percentage of Participants Achieving Leeds Dactylitis Index (LDI) =0 (in Participants With a Baseline LDI >=1) at Week 16 for Zasocitinib Dose A and B Compared to Placebo [Срок оценки: Baseline, at Week 16]

Критерии участия

Критерии включения

Age:

• The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is >=19 years of age.

Disease Characteristics:

• The participant has a diagnosis of PsA.
• The participant must have signs and symptoms of PsA for at least 3 months prior to screening.
• The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).
• The participant has active arthritis as shown by a minimum of >=3 tender joints in TJC68 and >=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.
• The participant has at least 1 active lesion of plaque PsO >=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.

Medications for PsA:

• The participant has had at least one of the following:

• Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \[EU\]/ European Economic Area \[EEA\]), OR
• Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).

Критерии исключения

PsA and PsO:

• The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.
• The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).

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 · 53 центра

• AARR- Chandler AZ — Chandler
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ — Phoenix
• First OC Dermatology Research Inc. — Fountain Valley
• Purushotham & Akther Kotha MD — La Mesa
• Triwest Research Associates LLC — La Mesa
• The Cohen Medical Centers — Thousand Oaks
• … и ещё 45 центров

Польша · 27 центров

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Мексика · 10 центров

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Болгария · 9 центров

• Diagnostic Consultative Centre - Focus-5 - LZIP EOOD — Sofia
• Military Medical Academy Multiprofile Hospital for Not Yet Recruiting Treatment - Sofia — Sofia
• Centre of Rheumatology St. Irina — Sofia
• Medical Center Medconsult Pleven OOD — Pleven
• AES Partner Site -Plovdiv — Plovdiv
• Medical Center Artmed OOD | Plovdiv, Bulgaria — Plovdiv
• Diagnostic- Consultative Center- 1- Ruse EOOD — Rousse
• Dr Stoyanka Vladeva IPSMP VBR | Stara Zagora, Bulgaria — Stara Zagora
• … и ещё 1 центр

Чехия · 9 центров

• Revmatologie s.r.o. | Brno, Czech Republic — Brno
• L.K.N. Arthrocentrum, s.r.o. - Revmatologicka — Hlučín
• Clintrial s.r.o. | Prague, Czech Republic — Prague
• … и ещё 6 центров

Италия · 9 центров

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Германия · 8 центров

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Венгрия · 6 центров

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Израиль · 6 центров

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Португалия · 6 центров

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Испания · 6 центров

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Бельгия · 5 центров

• Université Libre de Bruxelles — Anderlecht
• University Hospital Ghent — Ghent
• ReumaClinic Genk — Genk
• St Pierre Brussels — Brussels
• Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman — Liège

Чили · 5 центров

• El Centro de Estudios Reumatologicos (CER) — Providencia
• Clinica Dermacross S.A. — Santiago
• Centro de Estudios Clinicos — Santiago
• CTR Estudios — Santiago
• Centro Internacional de Estudios Clínicos — Santiago

Хорватия · 5 центров

• Medicinski Centar Kuna and Peric — Zagreb
• Clinical Hospital Centre Osijek — Osijek
• Clinical Hospital Center Rijeka — Rijeka
• University Hospital Centre Split — Split
• General Hospital Zadar — Zadar

Эстония · 5 центров

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Новая Зеландия · 5 центров

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South Korea · 5 центров

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Тайвань · 5 центров

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Латвия · 2 центра

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Пуэрто-Рико · 2 центра

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Идентификаторы

NCT: NCT06671483 · TAK-279-PsA-3001 · 2024-513111-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗