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Een onderzoek om de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van satralizumab te evalueren bij deelnemers met schildklieroogziekten (SatraGO-2) (SatraGO-2)

20 juli 2026 bijgewerkt door: Hoffmann-La Roche

Een fase III, gerandomiseerde, dubbelblinde, placebo-gecontroleerde, multicentrische studie om de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van satralizumab te evalueren bij deelnemers met matige tot ernstige schildklieroogziekten

Het doel van deze studie is om de werkzaamheid, veiligheid, farmacokinetiek en farmacodynamiek van subcutaan satralizumab, een recombinant, gehumaniseerd anti-interleukine-6 ​​(IL-6) receptor monoklonaal antilichaam, te beoordelen bij deelnemers met schildklieroogziekte (TED).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

127

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

- Klinische diagnose van schildklieroogziekte (TED) op basis van CAS

Uitsluitingscriteria:

  • Afname van CAS of proptosis van respectievelijk >= 2 punten of >= 2 mm in het onderzoeksoog tussen screening en onderzoeksbasislijn (dag 1)
  • Het vereisen van onmiddellijke chirurgische oogheelkundige interventie of het plannen van corrigerende chirurgie of bestraling in de loop van het onderzoek, naar het oordeel van de onderzoeker
  • Geïdentificeerde reeds bestaande oogziekte die, naar het oordeel van de onderzoeker, deelname aan het onderzoek zou uitsluiten of de interpretatie van de onderzoeksresultaten zou compliceren, inclusief decompensatie van het hoornvlies die niet reageert op medische behandeling en inclusief oogziekten die waarschijnlijk verboden therapie vereisen tijdens het onderzoek
  • Elke ernstige medische aandoening of afwijking in klinische laboratoriumtests die, naar het oordeel van de onderzoeker, de veilige deelname en voltooiing van het onderzoek van een individu in de weg staat
  • Zwanger of borstvoeding gevend, of de intentie om zwanger te worden tijdens het onderzoek of binnen 12 weken na de laatste dosis satralizumab

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Satralizumab
In de deel I-periode ontvangen de deelnemers elke 4 weken satralizumab (q4w), gevolgd door een op proptosis-respons gebaseerde geïndividualiseerde behandeling in deel II van het onderzoek.
Geneesmiddel: Satralizumab
Satralizumab wordt toegediend door middel van een SC-injectie.
Placebo-vergelijker: Placebo
In de periode van deel I krijgen de deelnemers q4w een placebo, gevolgd door een op proptosis-respons gebaseerde geïndividualiseerde behandeling in deel II van het onderzoek.
Geneesmiddel: Placebo
Placebo zal worden toegediend via SC-injectie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Up to Week 48
Up to Week 48
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Onderzoekers

  • Studie directeur: Clinical Trials, Hoffmann-La Roche

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 november 2023

Primaire voltooiing (Werkelijk)

24 juli 2025

Studie voltooiing (Werkelijk)

25 juni 2026

Studieregistratiedata

Eerst ingediend

25 oktober 2023

Eerst ingediend dat voldeed aan de QC-criteria

25 oktober 2023

Eerst geplaatst (Werkelijk)

30 oktober 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Gekwalificeerde onderzoekers kunnen toegang vragen tot gegevens op individueel patiëntniveau via het aanvraagplatform (www.vivli.org). Meer details over de criteria van Roche voor in aanmerking komende onderzoeken zijn hier beschikbaar (https://vivli.org/ourmember/roche/).

Voor meer details over het wereldwijde beleid van Roche inzake het delen van klinische informatie en hoe u toegang kunt aanvragen tot gerelateerde klinische onderzoeksdocumenten, kunt u hier terecht (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren