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Uno studio per valutare l'efficacia, la sicurezza, la farmacocinetica e la farmacodinamica di Satralizumab nei partecipanti con malattia dell'occhio della tiroide (SatraGO-2) (SatraGO-2)

20 luglio 2026 aggiornato da: Hoffmann-La Roche

Uno studio multicentrico di fase III, randomizzato, in doppio mascherato, controllato con placebo per valutare l'efficacia, la sicurezza, la farmacocinetica e la farmacodinamica di Satralizumab in partecipanti con malattia oculare tiroidea da moderata a grave

Lo scopo di questo studio è valutare l'efficacia, la sicurezza, la farmacocinetica e la farmacodinamica del satralizumab sottocutaneo, un anticorpo monoclonale ricombinante umanizzato anti-recettore dell'interleuchina-6 (IL-6), in partecipanti con malattia dell'occhio tiroideo (TED).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

127

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

- Diagnosi clinica della malattia dell'occhio della tiroide (TED) basata su CAS

Criteri di esclusione:

  • Diminuzione del CAS o della proptosi di >= 2 punti o >= 2 mm, rispettivamente, nell'occhio dello studio tra lo screening e il basale dello studio (giorno 1)
  • Richiedere un intervento chirurgico oftalmologico immediato o pianificare un intervento chirurgico correttivo o irradiazione durante il corso dello studio, a giudizio dello sperimentatore
  • Malattia oftalmica preesistente identificata che, a giudizio dello sperimentatore, precluderebbe la partecipazione allo studio o complicherebbe l'interpretazione dei risultati dello studio, inclusa la scompenso corneale che non risponde alla gestione medica e comprese le malattie oftalmiche che probabilmente richiederanno una terapia proibita durante lo studio
  • Qualsiasi condizione medica grave o anomalia nei test clinici di laboratorio che, a giudizio dello sperimentatore, preclude la partecipazione sicura di un individuo e il completamento dello studio
  • Incinta o allattamento o intenzione di iniziare una gravidanza durante lo studio o entro 12 settimane dalla dose finale di satralizumab

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Satralizumab
Nel periodo della Parte I, i partecipanti riceveranno satralizumab ogni 4 settimane (q4w) seguito da un trattamento individualizzato basato sulla risposta alla proptosi nella Parte II dello studio.
Droga: Satralizumab
Satralizumab sarà somministrato mediante iniezione SC.
Comparatore placebo: Placebo
Nel periodo della parte I, i partecipanti riceveranno un placebo ogni 4 settimane seguito da un trattamento individualizzato basato sulla risposta alla proptosi nella parte II dello studio.
Droga: Placebo
Il placebo verrà somministrato mediante iniezione SC

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to Week 48
Up to Week 48
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Investigatori

  • Direttore dello studio: Clinical Trials, Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 novembre 2023

Completamento primario (Effettivo)

24 luglio 2025

Completamento dello studio (Effettivo)

25 giugno 2026

Date di iscrizione allo studio

Primo inviato

25 ottobre 2023

Primo inviato che soddisfa i criteri di controllo qualità

25 ottobre 2023

Primo Inserito (Effettivo)

30 ottobre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GP44729
  • 2023-503669-50-00 (Ctis: EU CT Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso ai dati a livello di singolo paziente attraverso la piattaforma di richiesta (www.vivli.org). Ulteriori dettagli sui criteri di Roche per gli studi ammissibili sono disponibili qui (https://vivli.org/ourmember/roche/).

Per ulteriori dettagli sulla politica globale di Roche sulla condivisione delle informazioni cliniche e su come richiedere l'accesso ai documenti degli studi clinici correlati, vedere qui (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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