Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Официальное название

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Обзор

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Подробное описание

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Вмешательства

• Препарат Sonelokimab
  Sonelokimab
• Препарат Placebo
  Placebo
• Препарат Risankizumab
  Active comparator

Первичные конечные точки

• Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [Срок оценки: Week 16 compared to placebo]

Вторичные конечные точки (6)

• Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20) [Срок оценки: Week 16 compared to placebo]
• Response rate of participants achieving Minimal Disease Activity (MDA) [Срок оценки: Week 16 compared to placebo]
• Health Assessment Questionnaire- Disability Index (HAQ-DI) [Срок оценки: Week 16 compared to placebo]
• Psoriasis Area and Severity Index (PASI90) [Срок оценки: Week 16 compared to placebo]
• Short- form-36 (SF-36) Physical Component Summary (PCS) [Срок оценки: Week 16 compared to placebo]
• Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [Срок оценки: Week 16 compared to risankzumab]

Критерии участия

Критерии включения

• Participants must be ≥18 years of age .
• Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
• Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
• Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
• Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
• Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Критерии исключения

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
• Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
• Participants with a diagnosis of inflammatory bowel disease.
• Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
• Participants who have an established diagnosis of arthritis mutilans.
• Previous exposure to sonelokimab.
• Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 44 центра

• Clinical Site — Avondale
• Clinical Site — Chandler
• Clinical Site — Flagstaff
• Clinical Site — Mesa
• Clinical Site — Phoenix
• Clinical Site — Scottsdale
• Clinical Site — Tucson
• Clinical Site — Jonesboro
• … и ещё 36 центров

Польша · 26 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 13 центров

Список центров уточняется — проверьте первичный протокол.

Болгария · 11 центров

• Clinical Site — Pazardzhik
• Clinical Site — Pleven
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Rousse
• … и ещё 3 центра

Германия · 10 центров

• Clinical Site — Berlin
• Clinical Site — Berlin
• … и ещё 8 центров

Венгрия · 9 центров

Список центров уточняется — проверьте первичный протокол.

Грузия · 8 центров

• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi

Франция · 6 центров

• Clinical Site — Caluire-et-Cuire
• Clinical Site — Montpellier
• Clinical Site — Narbonne
• Clinical Site — Nice
• Clinical Site — Rouen
• Clinical Site — Tours

Канада · 5 центров

• Clinical Site — Toronto
• Clinical Site — Calgary
• Clinical Site — Trois-Rivières
• Clinical Site — Waterloo
• Clinical Site — Winnipeg

Чехия · 4 центра

• Clinical Site — Brno
• Clinical Site — Ostrava
• Clinical Site — Studénka
• Clinical Site — Zlín

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06641089 · M1095-PSA-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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