Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Исследование по оценке эффективности, безопасности, фармакокинетики и фармакодинамики сатрализумаба у участников с заболеваниями щитовидной железы и глаз (SatraGO-1)

7 июля 2026 г. обновлено: Hoffmann-La Roche

Фаза III, рандомизированное, двойное маскирование, плацебо-контролируемое, многоцентровое исследование для оценки эффективности, безопасности, фармакокинетики и фармакодинамики сатрализумаба у участников с умеренным или тяжелым заболеванием щитовидной железы и глаз

Целью данного исследования является оценка эффективности, безопасности, фармакокинетики и фармакодинамики подкожного сатрализумаба, рекомбинантного гуманизированного моноклонального антитела к рецептору интерлейкина-6 (IL-6), у участников с тиреоидной болезнью глаз (TED).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

131

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • New South Wales
      • Sydney, New South Wales, Австралия, 2000
        • Sydney Eye Hospital
    • South Australia
      • Adelaide, South Australia, Австралия, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, Австралия, 3002
        • Centre For Eye Research Australia
  • Австрия
      • Vienna, Австрия, 1090
        • Medizinische Universität Wien
  • Аргентина
      • Buenos Aires, Аргентина, C1425
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Capital Federal, Аргентина, C1015ABO
        • Centro Oftalmologico Dr. Charles S.A.
      • Capital Federal, Аргентина, C1120AAN
        • Oftalmos
      • Ciudad Autonoma Buenos Aires, Аргентина, C1061AAE
        • Buenos Aires Mácula
      • Mendoza, Аргентина, M5500BWG
        • Centrovision Mendoza
      • Rosario, Аргентина, S2000DLA
        • Grupo Laser Vision
  • Венгрия
      • Budapest, Венгрия, 1133
        • Budapest Retina Associates Kft.
  • Германия
      • Berlin, Германия, 13353
        • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
      • Dresden, Германия, 01307
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
      • Essen, Германия, 45147
        • Universitätsklinikum Essen
      • Freiburg im Breisgau, Германия, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Münster, Германия, 48149
        • Universitätsklinikum Münster
      • Tübingen, Германия, 72076
        • Universitäts-Augenklinik Tübingen
  • Гонконг
      • Mong Kok, Гонконг
        • Hong Kong Eye Hospital
  • Италия
    • Campania
      • Naples, Campania, Италия, 80131
        • A.O. U. Federico II
    • Lazio
      • Rome, Lazio, Италия, 00168
        • Fondazione Policlinico Universitario A Gemelli
    • Lombardy
      • Milan, Lombardy, Италия
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Varese, Lombardy, Италия, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • Tuscany
      • Pisa, Tuscany, Италия, 56124
        • Azienda Ospedaliero Universitaria Pisana
  • Сингапур
      • Singapore, Сингапур, 119074
        • National University Hospital
      • Singapore, Сингапур, 168751
        • Singapore Eye Research Institute
  • Соединенные Штаты
    • California
      • Beverly Hills, California, Соединенные Штаты, 90210
        • Thrive Health Research LLC
      • La Jolla, California, Соединенные Штаты, 92093-0946
        • UCSD Shiley Eye Center
    • Kansas
      • Wichita, Kansas, Соединенные Штаты, 67206
        • Grene Vision Group, LLC
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48105
        • University of Michigan, Kellogg Eye Center
      • Saint Joseph, Michigan, Соединенные Штаты, 49085
        • Great Lakes Eye Care
    • New York
      • Great Neck, New York, Соединенные Штаты, 11021
        • 'Northwell Health Physician Partners Ophthalmology
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97225
        • EyeHealth Northwest
    • Texas
      • Austin, Texas, Соединенные Штаты, 78705-1169
        • Austin Retina Associates
    • Utah
      • Salt Lake City, Utah, Соединенные Штаты, 84102
        • Eyelid Center of Utah
    • West Virginia
      • Morgantown, West Virginia, Соединенные Штаты, 26506
        • WVU Eye Institute
  • Япония
      • Aichi, Япония, 480-1195
        • Aichi Medical University Hospital
      • Fukuoka, Япония, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Япония, 830-8577
        • Social Medical Corporation Tenjinkai Shinkoga Hospital
      • Hokkaido, Япония, 060-8648
        • Hokkaido University Hospital
      • Hyōgo, Япония, 657-0068
        • Kobe Kaisei Hospital Medical foundation
      • Kitakyushu-shi, Япония, 807-8556
        • Hospital of the University of Occupational and Environmental Health,Japan
      • Kyoto, Япония, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Miyazaki, Япония, 889-1692
        • University of Miyazaki Hospital
      • Osaka, Япония, 545-8586
        • Osaka Metropolitan university Hospital
      • Tokyo, Япония, 150-0001
        • Olympia Eye Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Критерии включения:

- Клиническая диагностика тиреоидной болезни глаз (TED) на основе CAS

Критерий исключения:

  • Снижение CAS или экзофтальма >= 2 баллов или >= 2 мм соответственно в исследуемом глазу между скринингом и исходным уровнем исследования (день 1)
  • Требование немедленного хирургического офтальмологического вмешательства или планирование корректирующей операции или облучения в ходе исследования, по мнению исследователя.
  • Выявленное ранее существовавшее офтальмологическое заболевание, которое, по мнению исследователя, препятствует участию в исследовании или усложняет интерпретацию результатов исследования, включая декомпенсацию роговицы, не поддающуюся медикаментозному лечению, и включая офтальмологические заболевания, которые, вероятно, потребуют запрещенной терапии во время исследования.
  • Любое серьезное заболевание или отклонение от нормы в клинических лабораторных тестах, которые, по мнению исследователя, препятствуют безопасному участию человека в исследовании и его завершению.
  • Беременность или кормление грудью, или намерение забеременеть во время исследования или в течение 12 недель после последней дозы сатрализумаба

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Сатрализумаб
В период части I участники будут получать сатрализумаб каждые 4 недели (каждые 4 недели), после чего в части II исследования будет проводиться индивидуальное лечение, основанное на ответе на экзофтальм.
Лекарство: Сатрализумаб
Сатрализумаб будет вводиться подкожно.
Плацебо Компаратор: Плацебо
В период части I участники будут получать плацебо каждые 4 недели с последующим индивидуальным лечением, основанным на реакции на проптоз, в части II исследования.
Лекарство: Плацебо
Плацебо будет вводиться путем подкожной инъекции.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Временное ограничение: At Week 24
Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
At Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Временное ограничение: At Week 24
Percentage of participants in the overall population (i.e., participants with active and chronic inactive TED) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
At Week 24
Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
Временное ограничение: At Week 24
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Временное ограничение: At Week 24
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Временное ограничение: At Week 24
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Participants with active TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported. Percentages have been rounded off.
At Week 24
Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Временное ограничение: At Week 24
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Participants with active and chronic inactive TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24
Временное ограничение: At Week 24
Percentages have been rounded off.
At Week 24
Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24
Временное ограничение: At Week 24
Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Visual Functioning Subscale of the Graves' Ophthalmopathy Quality of Life (GO-QoL) From Baseline at Week 24
Временное ограничение: At Week 24
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population With a ≥6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24
Временное ограничение: At Week 24
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
Временное ограничение: At Week 24
Overall Response was defined as a ≥ 2-point reduction in clinical activity score (CAS), and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis (≥ 2-point/mm increase) in the fellow eye. The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24
Временное ограничение: At Week 24
CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24
Временное ограничение: At Week 24
CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms. Percentages have been rounded off.
At Week 24
Percentage of Participants With a ≥10-point Improvement in the Ocular Surface Disease Index (OSDI) Overall Scores Across All Levels of Baseline Severity at Week 24 in Overall Population
Временное ограничение: At Week 24
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represent a worse disease index. Percentages have been rounded off.
At Week 24
Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population
Временное ограничение: At Week 24
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represent a worse disease index.
At Week 24
Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
Временное ограничение: At Week 24
Corneal staining was graded using Oxford Corneal Staining Chart which consists of a 6-point scale. Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (0=absent; I=minimal; II=mild; III=moderate; IV= marked; and V=severe). Higher grade indicates worse disease index. The observer compares the overall appearance of the participant's corneal staining with the reference figure in the protocol. The observer selects the appropriate grade that best represents the state of corneal staining. The staining score were recorded for the exposed interpalpebral cornea and conjunctiva.
At Week 24
Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
Временное ограничение: At Week 24
The percentage of participants achieving a complete binocular diplopia response (diplopia score=0) at Week 24 have been reported. Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
At Week 24
Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye
Временное ограничение: At Week 48
Percentage of participants who will achieve a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 48 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye will be reported.
At Week 48
Percentage of Participants Achieving Overall Response at Week 48
Временное ограничение: At Week 48
Overall Response is defined as a ≥ 2-point reduction in CAS, and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis ( ≥ 2-point/mm increase) in the fellow eye. The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
At Week 48
Percentage of Participants Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline at Week 48
Временное ограничение: At Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
At Week 48
Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
Временное ограничение: At Week 48
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
At Week 48
Percentage of Participants With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL at Week 48
Временное ограничение: At Week 48
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
At Week 48
Change From Baseline in Proptosis at Week 48
Временное ограничение: At Week 48
At Week 48
Percentage of Participants Requiring Surgical Intervention for TED up to Week 48
Временное ограничение: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Временное ограничение: From Week 24 to Week 48
From Week 24 to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Временное ограничение: From Baseline to Week 48
From Baseline to Week 48
Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48
Временное ограничение: Week 24, Week 48
Week 24, Week 48
Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48
Временное ограничение: Week 24, Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Week 24, Week 48
Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48
Временное ограничение: At Week 48
At Week 48
Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48
Временное ограничение: At Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
At Week 48
Change in Proptosis From Week 24 to 48
Временное ограничение: From Week 24 to Week 48
From Week 24 to Week 48
Change in CAS From Week 24 to 48
Временное ограничение: From Week 24 to Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
From Week 24 to Week 48
Percentage of Participants With a ≥6-point Improvement in the Visual Functioning and Appearance Subscale Score of the GO-QoL From Week 24 at Week 48
Временное ограничение: Week 24, Week 48
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
Week 24, Week 48
Change From Baseline in Proptosis to Week 48
Временное ограничение: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in CAS to Week 48
Временное ограничение: Baseline up to Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Baseline up to Week 48
Number of Participants With Adverse Events (AEs)
Временное ограничение: Up to Week 72
An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Up to Week 72
Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints
Временное ограничение: Baseline, Weeks 2, 4, 8, 12 and 24
Baseline, Weeks 2, 4, 8, 12 and 24
Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study
Временное ограничение: Up to Week 48
Up to Week 48

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Hoffmann-La Roche

Следователи

  • Директор по исследованиям: Clinical Trials, Hoffmann-La Roche

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

26 октября 2023 г.

Первичное завершение (Действительный)

8 июля 2025 г.

Завершение исследования (Действительный)

25 июня 2026 г.

Даты регистрации исследования

Первый отправленный

5 июля 2023 г.

Впервые представлено, что соответствует критериям контроля качества

4 августа 2023 г.

Первый опубликованный (Действительный)

14 августа 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

31 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • GP44467
  • 2023-503309-13-00 (Ктис: EU CT Number)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Квалифицированные исследователи могут запросить доступ к данным на уровне отдельных пациентов через платформу запросов (www.vivli.org). Дополнительные сведения о критериях «Рош» для приемлемых исследований доступны здесь (https://vivli.org/ourmember/roche/).

Дополнительные сведения о Глобальной политике компании «Рош» в отношении обмена клинической информацией и о том, как запросить доступ к соответствующим документам клинических исследований, см. здесь (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться