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Идёт набор NCT06440525

A Study of RSLV-132 in Females With Sjögren's Disease

Фаза II С лечением Primary Sjögren Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RSLV-132, Placebo.
Кому может быть актуально
Состояния в реестре: Primary Sjögren Syndrome. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden

Обзор

The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: * Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? * Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's? * What are the blood levels of RSLV-132 over time? * What is the immune (antibody) response in the body to RSLV-132? * What is the safety profile of RSLV-132? Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS. Participants will: Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device

Вмешательства

  • Препарат RSLV-132
    Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
  • Препарат Placebo
    0.9% sodium chloride solution

Первичные конечные точки

  • Assessment of cardinal symptoms of Sjogren's [Срок оценки: Measured daily from at least 7 days prior to first dose until 169 days after the first dose]
Вторичные конечные точки (4)
  • Tiredness/fatigue assessment [Срок оценки: Measured from before the first dose until Day 169]
  • RSLV-132 pharmacokinetics [Срок оценки: Measured from before the first dose until Day 211]
  • RSLV-132 immunogenicity [Срок оценки: Measured from before the first dose until Day 211]
  • Adverse events [Срок оценки: From the first dose of Investigational Product until Day 211]

Критерии участия

Критерии включения

  • Providing written informed consent
  • Weight at least 45 kg
  • Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
  • Diagnosis in the last 30 years
  • Positive anti-Ro/SSA antibody test
  • Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
  • Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures

Критерии исключения

  • Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
  • Uncontrolled hypothyroidism or severe fibromyalgia
  • New medications or change in medications in the last 4 weeks for pSS symptoms
  • Receipt of other prohibited medications
  • Apheresis or blood donation
  • Allergic reaction to RSLV-132 or biologic therapy
  • Clinically significant infection in last 30 days
  • Participation in another clinical study
  • Malignancy in last 5 years
  • Positive test for HIV or hepatitis
  • Major surgery in last 30 days or anticipated surgery during the study
  • Pregnancy or breast feeding
  • Laboratory blood tests outside of specified ranges
  • Other medical conditions or medications that would make the participant unsuitable

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 · 24 центра
  • Resolve Clinical Site — Chula Vista
  • Resolve Clinical Site — Tustin
  • Resolve Clinical Site — Boca Raton
  • Resolve Clinical Site — Boynton Beach
  • Evolution Research Center — Hialeah
  • GNP Research — Hollywood
  • Resolve Clinical Site — Miami
  • Life Medical Research — Miami Gardens
  • … и ещё 16 центров

Публикации

  • Posada J, Valadkhan S, Burge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF. Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjogren's Syndrome: A Randomized Clinical Trial. Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22. PMID 32798283
  • Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Coho PMID 27785888

Идентификаторы

NCT: NCT06440525 · 132-6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗