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Исследование по оценке эффективности, безопасности, фармакокинетики и фармакодинамики сатрализумаба у участников с заболеванием щитовидной железы и глаз (SatraGO-2) (SatraGO-2)

20 июля 2026 г. обновлено: Hoffmann-La Roche

Фаза III, рандомизированное, двойное, плацебо-контролируемое, многоцентровое исследование для оценки эффективности, безопасности, фармакокинетики и фармакодинамики сатрализумаба у участников с заболеванием щитовидной железы средней и тяжелой степени

Целью данного исследования является оценка эффективности, безопасности, фармакокинетики и фармакодинамики сатрализумаба для подкожного введения, рекомбинантного гуманизированного моноклонального антитела против рецептора интерлейкина-6 (IL-6), у участников с заболеванием щитовидной железы (TED).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

127

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

  • Израиль
      • Jerusalem, Израиль, 9112001
        • Hadassah MC
      • Petah Tikva, Израиль, 4941492
        • Rabin MC
      • Ramat Gan, Израиль
        • Sheba medical center
  • Испания
      • Barcelona, Испания, 08035
        • Hospital Universitario Vall D hebron
      • Granada, Испания, 18012
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Испания, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Испания, 28031
        • Hospital Ramon y Cajal
      • Seville, Испания, 41007
        • Hospital Universitario Virgen De La Macarena
      • Valencia, Испания, 46026
        • Hospital Universitario la Fe: Servicio de Oftalmologia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Испания, 8907
        • Hospital Universitari de Bellvitge
  • Канада
    • Alberta
      • Edmonton, Alberta, Канада
        • University of Alberta
    • Ontario
      • Toronto, Ontario, Канада, M3C 0G9
        • Toronto Retina Institute
    • Quebec
      • Montreal, Quebec, Канада, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont
  • Китай
      • Beijing, Китай, 100191
        • Peking University Third Hospital
      • Beijing, Китай, 100032
        • Peking Union Medical College Hospital
      • Beijing, Китай, 100730
        • Beijing Hospital of Ministry of Health
      • Beijing, Китай, 100730
        • Beijing Tongren Hospital, Capital Medical University
      • Xi'an, Китай, 710004
        • Xi'an Fourth Hospital
  • Польша
      • Bydgoszcz, Польша, 85-316
        • Specjalistyczny Osrodek Okulistyczny Oculomedica
      • Gdansk, Польша, 80-180
        • Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
  • Португалия
      • Coimbra, Португалия, 3000-548
        • AIBILI - Association for Innovation and Biomedical Research on Light
  • Соединенное Королевство
      • Brighton, Соединенное Королевство, BN2 5BF
        • Sussex Eye Hospital
      • Bristol, Соединенное Королевство, BS1 2LX
        • Bristol Eye Hospital
      • Glasgow, Соединенное Королевство, G12 0YN
        • Gartnavel General Hospital
      • Leeds, Соединенное Королевство, LS9 7TF
        • St James University Hospital
      • Liverpool, Соединенное Королевство, L7 8XP
        • Royal Liverpool University Hospital
      • London, Соединенное Королевство, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
      • Maidstone, Kent, Соединенное Королевство, ME16 9QQ
        • Maidstone Hospital
  • Соединенные Штаты
    • California
      • San Diego, California, Соединенные Штаты, 92108
        • Plastics-Orbit-Neuro
    • Connecticut
      • Danbury, Connecticut, Соединенные Штаты, 06810
        • Connecticut Eye Consultants, P.C.
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60612
        • University of Illinois Eye and Ear Infirmary
    • Pennsylvania
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Scheie Eye Institute
    • Tennessee
      • Nashville, Tennessee, Соединенные Штаты, 37232-8808
        • Vanderbilt Eye Institute
    • Texas
      • San Antonio, Texas, Соединенные Штаты, 78251
        • Retina Consultants of Texas
  • Франция
      • Nantes, Франция, 44093
        • CHU Nantes - Hôtel Dieu
      • Paris, Франция, 75019
        • Fondation Rothschild
      • Paris, Франция, 75012
        • CHNO Hopital des Quinze Vingts
  • Южная Корея
      • Seongnam-si, Южная Корея, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Южная Корея, 003-722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Южная Корея, 135-710
        • Samsung Medical Center
      • Seoul, Южная Корея, 06973
        • Chung-Ang University 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 заболеваний глаз щитовидной железы (TED) на основе CAS.

Критерий исключения:

  • Снижение CAS или проптоз >= 2 баллов или >= 2 мм соответственно в исследуемом глазу между скринингом и исходным уровнем исследования (день 1)
  • По мнению исследователя, необходимость немедленного хирургического офтальмологического вмешательства или планирование корректирующей операции или облучения в ходе исследования.
  • Выявлено ранее существовавшее офтальмологическое заболевание, которое, по мнению исследователя, могло бы препятствовать участию в исследовании или усложнить интерпретацию результатов исследования, включая декомпенсацию роговицы, не поддающуюся медикаментозному лечению, а также офтальмологические заболевания, которые, вероятно, потребуют запрещенной терапии во время исследования.
  • Любое серьезное заболевание или отклонения в результатах клинических лабораторных исследований, которые, по мнению исследователя, исключают безопасное участие человека в исследовании и его завершение.
  • Беременность или кормление грудью, или намерение забеременеть во время исследования или в течение 12 недель после приема 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) с последующим индивидуальным лечением, основанным на реакции проптоза, в Части II исследования.
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 проптоза, 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 have been reported. Percentages have been rounded off.
At Week 24

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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 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
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
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 have 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
This analysis used a Mixed-effects Model for Repeated Measure (MMRM) model. Adjusted mean values have been reported here.
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Временное ограничение: At Week 24
This analysis used a MMRM model. Adjusted mean values have been reported here.
At Week 24
Percentage of Participants in 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 is 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 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. This analysis used a MMRM model. Adjusted mean values have been reported here.
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. This analysis used a MMRM model. Adjusted mean values have been reported here.
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). Percentages have been rounded off.
At Week 24
Percentage of Participants (Proptosis Non-responders at Week 24) Achieving ≥ 2 mm Reduction in Proptosis at Week 48 in the Study Eye
Временное ограничение: At Week 48
Percentage of participants (proptosis non-responders) 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 (Proptosis Non-responders at Week 24) 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 (Proptosis Non-responders at Week 24) Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 48
Временное ограничение: Baseline 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 to Week 48
Percentage of Participants (Proptosis Non-responders at Week 24) 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 (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
Временное ограничение: From Week 24 to 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.
From Week 24 to Week 48
Percentage of Participants (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
Временное ограничение: From baseline up to 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.
From baseline up to Week 48
Change From Baseline in Proptosis at Week 48 (in Proptosis Non-responders at Week 24)
Временное ограничение: Baseline and Week 48
Proptosis response is defined as achieving 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.
Baseline and Week 48
Percentage of Participants (Proptosis Non-responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Временное ограничение: Up to Week 48
Up to Week 48
Percentage of Participants (Proptosis Responders at Week 24) 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 (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Временное ограничение: Baseline to Week 48
Baseline to Week 48
Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Week 24 at Week 48
Временное ограничение: Weeks 24 and 48
Proptosis response is defined as achieving 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.
Weeks 24 and 48
Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Week 24 at Week 48
Временное ограничение: Weeks 24 and 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.
Weeks 24 and 48
Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Baseline at Week 48
Временное ограничение: At Week 48
Proptosis response is defined as achieving 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.
At Week 48
Percentage of Participants (Proptosis Responders at Week 24) 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 (in Proptosis Responders at Week 24)
Временное ограничение: From Week 24 to Week 48
Proptosis response is defined as achieving 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.
From Week 24 to Week 48
Change in CAS From Week 24 to 48 (in Proptosis Responders at Week 24)
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 (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
Временное ограничение: From Week 24 to 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.
From Week 24 to Week 48
Percentage of Participants (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
Временное ограничение: From baseline up to 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.
From baseline up to Week 48
Change From Baseline in Proptosis to Week 48 (in Proptosis Responders at Week 24)
Временное ограничение: Baseline to Week 48
Proptosis response is defined as achieving 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.
Baseline to Week 48
Change From Baseline in CAS to Week 48 (in Proptosis Responders at Week 24)
Временное ограничение: Baseline 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 to Week 48
Percentage of Participants (Proptosis Responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Временное ограничение: Up to Week 48
Up to Week 48
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Временное ограничение: Up to Week 48
Participants will be considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).
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)

15 ноября 2023 г.

Первичное завершение (Действительный)

24 июля 2025 г.

Завершение исследования (Действительный)

25 июня 2026 г.

Даты регистрации исследования

Первый отправленный

25 октября 2023 г.

Впервые представлено, что соответствует критериям контроля качества

25 октября 2023 г.

Первый опубликованный (Действительный)

30 октября 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

12 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • GP44729
  • 2023-503669-50-00 (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). Более подробную информацию о критериях «Рош» для участия в исследованиях можно найти здесь (https://vivli.org/ourmember/roche/).

Более подробную информацию о глобальной политике «Рош» в отношении обмена клинической информацией и о том, как запросить доступ к соответствующим документам клинических исследований, можно найти 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. .

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