Un estudio para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de satralizumab en participantes con enfermedad ocular tiroidea (SatraGO-2) (SatraGO-2)
20 de julio de 2026 actualizado por: Hoffmann-La Roche
Un estudio multicéntrico de fase III, aleatorizado, doble enmascarado, controlado con placebo para evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de satralizumab en participantes con enfermedad ocular tiroidea de moderada a grave
El propósito de este estudio es evaluar la eficacia, seguridad, farmacocinética y farmacodinamia de satralizumab subcutáneo, un anticuerpo monoclonal humanizado recombinante anti-receptor de interleucina-6 (IL-6), en participantes con enfermedad ocular tiroidea (TED).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
127
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alberta
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Edmonton, Alberta, Canadá
- University of Alberta
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Ontario
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Toronto, Ontario, Canadá, M3C 0G9
- Toronto Retina Institute
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont
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Seongnam-si, Corea del Sur, 13620
- Seoul National University Bundang Hospital
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Seoul, Corea del Sur, 003-722
- Severance Hospital, Yonsei University Health System
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Seoul, Corea del Sur, 135-710
- Samsung Medical Center
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Seoul, Corea del Sur, 06973
- Chung-Ang University Hospital
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Barcelona, España, 08035
- Hospital Universitario Vall D hebron
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Granada, España, 18012
- Hospital Universitario Virgen de las Nieves
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Madrid, España, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, España, 28031
- Hospital Ramon y Cajal
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Seville, España, 41007
- Hospital Universitario Virgen De La Macarena
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Valencia, España, 46026
- Hospital Universitario la Fe: Servicio de Oftalmologia
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, España, 8907
- Hospital Universitari de Bellvitge
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California
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San Diego, California, Estados Unidos, 92108
- Plastics-Orbit-Neuro
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
- Connecticut Eye Consultants, P.C.
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Eye and Ear Infirmary
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Scheie Eye Institute
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232-8808
- Vanderbilt Eye Institute
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Texas
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San Antonio, Texas, Estados Unidos, 78251
- Retina Consultants of Texas
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Nantes, Francia, 44093
- CHU Nantes - Hôtel Dieu
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Paris, Francia, 75019
- Fondation Rothschild
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Paris, Francia, 75012
- CHNO Hopital des Quinze Vingts
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Jerusalem, Israel, 9112001
- Hadassah MC
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Petah Tikva, Israel, 4941492
- Rabin MC
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Ramat Gan, Israel
- Sheba medical center
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Bydgoszcz, Polonia, 85-316
- Specjalistyczny Osrodek Okulistyczny Oculomedica
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Gdansk, Polonia, 80-180
- Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
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Beijing, Porcelana, 100191
- Peking University Third Hospital
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Beijing, Porcelana, 100032
- Peking Union Medical College Hospital
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Beijing, Porcelana, 100730
- Beijing Hospital of Ministry of Health
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Beijing, Porcelana, 100730
- Beijing Tongren Hospital, Capital Medical University
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Xi'an, Porcelana, 710004
- Xi'an Fourth Hospital
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Coimbra, Portugal, 3000-548
- AIBILI - Association for Innovation and Biomedical Research on Light
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Brighton, Reino Unido, BN2 5BF
- Sussex Eye Hospital
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Bristol, Reino Unido, BS1 2LX
- Bristol Eye Hospital
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Glasgow, Reino Unido, G12 0YN
- Gartnavel General Hospital
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Leeds, Reino Unido, LS9 7TF
- St James University Hospital
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Liverpool, Reino Unido, L7 8XP
- Royal Liverpool University Hospital
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London, Reino Unido, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Maidstone, Kent, Reino Unido, ME16 9QQ
- Maidstone Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Diagnóstico clínico de la enfermedad ocular tiroidea (TED) basado en CAS.
Criterio de exclusión:
- Disminución de CAS o proptosis de >= 2 puntos o >= 2 mm, respectivamente, en el ojo del estudio entre la selección y el inicio del estudio (día 1)
- Requerir intervención oftalmológica quirúrgica inmediata o planificar cirugía correctiva o irradiación durante el curso del estudio, a juicio del investigador.
- Enfermedad oftálmica preexistente identificada que, a juicio del investigador, impediría la participación en el estudio o complicaría la interpretación de los resultados del estudio, incluida la descompensación corneal que no responde al tratamiento médico e incluye enfermedades oftálmicas que probablemente requerirán terapia prohibida durante el estudio.
- Cualquier condición médica grave o anomalía en las pruebas de laboratorio clínico que, a juicio del investigador, impide la participación segura de un individuo en el estudio y su finalización.
- Embarazada o amamantando, o intención de quedar embarazada durante el estudio o dentro de las 12 semanas posteriores a la dosis final de satralizumab
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Satralizumab
En el período de la Parte I, los participantes recibirán satralizumab cada 4 semanas (cada 4 semanas) seguido de un tratamiento individualizado basado en la respuesta de proptosis en la Parte II del estudio.
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Satralizumab se administrará mediante inyección SC.
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Comparador de placebos: Placebo
En el período de la parte I, los participantes recibirán placebo cada 4 semanas seguido de un tratamiento individualizado basado en la respuesta de proptosis en la parte II del estudio.
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El placebo se administrará mediante inyección subcutánea.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24
Periodo de tiempo: At Week 24
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Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Number of Participants With Adverse Events (AEs)
Periodo de tiempo: Up to Week 72
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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.
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Up to Week 72
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Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints
Periodo de tiempo: Baseline, Weeks 2, 4, 8, 12 and 24
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Baseline, Weeks 2, 4, 8, 12 and 24
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Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
Periodo de tiempo: At Week 24
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This analysis used a Mixed-effects Model for Repeated Measure (MMRM) model.
Adjusted mean values have been reported here.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Periodo de tiempo: At Week 24
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This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Spontaneous Pain at Week 24
Periodo de tiempo: At Week 24
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Percentages have been rounded off.
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At Week 24
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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
Periodo de tiempo: At Week 24
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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.
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At Week 24
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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
Periodo de tiempo: At Week 24
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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.
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At Week 24
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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
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
Periodo de tiempo: At Week 24
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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.
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At Week 24
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving ≥ 2 mm Reduction in Proptosis at Week 48 in the Study Eye
Periodo de tiempo: At Week 48
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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.
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At Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving Overall Response at Week 48
Periodo de tiempo: At Week 48
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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.
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At Week 48
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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
Periodo de tiempo: Baseline to Week 48
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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.
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Baseline to Week 48
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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
Periodo de tiempo: At Week 48
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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).
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At Week 48
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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
Periodo de tiempo: From Week 24 to Week 48
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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.
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From Week 24 to Week 48
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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
Periodo de tiempo: From baseline up to Week 48
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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.
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From baseline up to Week 48
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Change From Baseline in Proptosis at Week 48 (in Proptosis Non-responders at Week 24)
Periodo de tiempo: Baseline and Week 48
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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.
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Baseline and Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Periodo de tiempo: Up to Week 48
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Up to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Periodo de tiempo: From Week 24 to Week 48
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Periodo de tiempo: Baseline to Week 48
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Baseline to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Week 24 at Week 48
Periodo de tiempo: Weeks 24 and 48
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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.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Week 24 at Week 48
Periodo de tiempo: Weeks 24 and 48
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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.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Baseline at Week 48
Periodo de tiempo: At Week 48
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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.
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At Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Baseline at Week 48
Periodo de tiempo: At Week 48
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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.
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At Week 48
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Change in Proptosis From Week 24 to 48 (in Proptosis Responders at Week 24)
Periodo de tiempo: From Week 24 to Week 48
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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.
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From Week 24 to Week 48
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Change in CAS From Week 24 to 48 (in Proptosis Responders at Week 24)
Periodo de tiempo: From Week 24 to Week 48
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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.
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From Week 24 to Week 48
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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
Periodo de tiempo: From Week 24 to Week 48
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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.
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From Week 24 to Week 48
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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
Periodo de tiempo: From baseline up to Week 48
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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.
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From baseline up to Week 48
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Change From Baseline in Proptosis to Week 48 (in Proptosis Responders at Week 24)
Periodo de tiempo: Baseline to Week 48
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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.
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Baseline to Week 48
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Change From Baseline in CAS to Week 48 (in Proptosis Responders at Week 24)
Periodo de tiempo: Baseline to Week 48
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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.
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Baseline to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Periodo de tiempo: Up to Week 48
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Up to Week 48
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Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Periodo de tiempo: Up to Week 48
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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).
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Up to Week 48
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de noviembre de 2023
Finalización primaria (Actual)
24 de julio de 2025
Finalización del estudio (Actual)
25 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
25 de octubre de 2023
Primero enviado que cumplió con los criterios de control de calidad
25 de octubre de 2023
Publicado por primera vez (Actual)
30 de octubre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Genéticas Congénitas
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de los ojos
- Enfermedades De Los Ojos Hereditarias
- La enfermedad de Graves
- Exoftalmos
- Enfermedades Orbitales
- Coto
- Hipertiroidismo
- Enfermedades de la tiroides
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Oftalmopatía de Graves
- satralizumab
Otros números de identificación del estudio
- GP44729
- 2023-503669-50-00 (Ctis: EU CT Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los investigadores calificados pueden solicitar acceso a datos a nivel de paciente individual a través de la plataforma de solicitud (www.vivli.org). Más detalles sobre los criterios de Roche para los estudios elegibles están disponibles aquí (https://vivli.org/ourmember/roche/).
Para obtener más detalles sobre la Política global de Roche sobre el intercambio de información clínica y cómo solicitar acceso a documentos de estudios clínicos relacionados, consulte aquí (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .