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评估 Satralizumab 对甲状腺眼病患者的疗效、安全性、药代动力学和药效学的研究 (SatraGO-2) (SatraGO-2)

2026年7月20日更新者：Hoffmann-La Roche

一项随机、双盲、安慰剂对照、多中心 III 期研究，旨在评估 Satralizumab 在中度至重度甲状腺眼病受试者中的疗效、安全性、药代动力学和药效学

本研究的目的是评估皮下注射 satralizumab（一种重组人源化抗白细胞介素 6 (IL-6) 受体单克隆抗体）在甲状腺眼病 (TED) 受试者中的疗效、安全性、药代动力学和药效学。

研究概览

地位

完全的

条件

甲状腺眼病

干预/治疗

研究类型

介入性

注册 (实际的)

127

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

纳入标准：

- 基于CAS的甲状腺眼病（TED）临床诊断

排除标准：

在筛选和研究基线（第 1 天）之间，研究眼中 CAS 或突眼分别减少 >= 2 点或 >= 2 mm
根据研究者的判断，在研究过程中需要立即进行眼科手术干预或计划进行矫正手术或放射治疗
根据研究者的判断，已确定的既往存在的眼科疾病将妨碍研究参与或使研究结果的解释变得复杂，包括对医疗管理无反应的角膜失代偿，以及包括在研究期间可能需要禁止治疗的眼科疾病
任何严重的医疗状况或临床实验室测试异常，根据研究者的判断，妨碍个人安全参与和完成研究
怀孕或哺乳，或在研究期间或最后一次服用 satralizumab 后 12 周内有意怀孕

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：沙他利珠单抗在第一部分期间，参与者将每 4 周 (q4w) 接受一次 satralizumab，然后在研究的第二部分中进行基于眼球突出反应的个体化治疗。	药品：沙他利珠单抗 Satralizumab 将通过 SC 注射进行给药。
安慰剂比较：安慰剂在第一部分期间，参与者将接受每 4 周一次安慰剂，然后在研究的第二部分中进行基于眼球突出反应的个体化治疗。	药品：安慰剂安慰剂将通过 SC 注射给药

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：Up to Week 48		Up to Week 48
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study 大体时间：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

合作者和调查者

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调查人员

研究主任：Clinical Trials、Hoffmann-La Roche

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负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Ezra D, Collins A, Haskova Z, Kuenzel T, Ida H, Triyatni M, Brittain C, Idowu O. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025 Dec;14(12):3119-3132. doi: 10.1007/s40123-025-01255-3. Epub 2025 Oct 9.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年11月15日

初级完成 (实际的)

2025年7月24日

研究完成 (实际的)

2026年6月25日

研究注册日期

首次提交

2023年10月25日

首先提交符合 QC 标准的

2023年10月25日

首次发布 (实际的)

2023年10月30日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

评估 Satralizumab 对甲状腺眼病患者的疗效、安全性、药代动力学和药效学的研究 (SatraGO-2) (SatraGO-2)

一项随机、双盲、安慰剂对照、多中心 III 期研究，旨在评估 Satralizumab 在中度至重度甲状腺眼病受试者中的疗效、安全性、药代动力学和药效学

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品