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Eine Studie zur Bewertung der Wirksamkeit, Sicherheit, Pharmakokinetik und Pharmakodynamik von Satralizumab bei Teilnehmern mit Schilddrüsen-Augenerkrankungen (SatraGO-1)

7. Juli 2026 aktualisiert von: Hoffmann-La Roche

Eine randomisierte, doppelmaskierte, placebokontrollierte, multizentrische Phase-III-Studie zur Bewertung der Wirksamkeit, Sicherheit, Pharmakokinetik und Pharmakodynamik von Satralizumab bei Teilnehmern mit mittelschwerer bis schwerer Schilddrüsen-Augenerkrankung

Der Zweck dieser Studie besteht darin, die Wirksamkeit, Sicherheit, Pharmakokinetik und Pharmakodynamik von subkutan verabreichtem Satralizumab, einem rekombinanten, humanisierten monoklonalen Anti-Interleukin-6 (IL-6)-Rezeptor-Antikörper, bei Teilnehmern mit Schilddrüsen-Augenerkrankung (TED).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

131

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, C1425
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Capital Federal, Argentinien, C1015ABO
        • Centro Oftalmologico Dr. Charles S.A.
      • Capital Federal, Argentinien, C1120AAN
        • Oftalmos
      • Ciudad Autonoma Buenos Aires, Argentinien, C1061AAE
        • Buenos Aires Mácula
      • Mendoza, Argentinien, M5500BWG
        • Centrovision Mendoza
      • Rosario, Argentinien, S2000DLA
        • Grupo Laser Vision
  • Australien
    • New South Wales
      • Sydney, New South Wales, Australien, 2000
        • Sydney Eye Hospital
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Royal Adelaide Hospital
    • Victoria
      • East Melbourne, Victoria, Australien, 3002
        • Centre for Eye Research Australia
  • Deutschland
      • Berlin, Deutschland, 13353
        • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
      • Dresden, Deutschland, 01307
        • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
      • Essen, Deutschland, 45147
        • Universitätsklinikum Essen
      • Freiburg im Breisgau, Deutschland, 79106
        • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
      • Münster, Deutschland, 48149
        • Universitätsklinikum Münster
      • Tübingen, Deutschland, 72076
        • Universitäts-Augenklinik Tübingen
  • Hongkong
      • Mong Kok, Hongkong
        • Hong Kong Eye Hospital
  • Italien
    • Campania
      • Naples, Campania, Italien, 80131
        • A.O. U. Federico II
    • Lazio
      • Rome, Lazio, Italien, 00168
        • Fondazione Policlinico Universitario A Gemelli
    • Lombardy
      • Milan, Lombardy, Italien
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Varese, Lombardy, Italien, 21100
        • Ospedale di Circolo e Fondazione Macchi
    • Tuscany
      • Pisa, Tuscany, Italien, 56124
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Japan, 830-8577
        • Social Medical Corporation Tenjinkai Shinkoga Hospital
      • Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • Hyōgo, Japan, 657-0068
        • Kobe Kaisei Hospital Medical foundation
      • Kitakyushu-shi, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health,Japan
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital
      • Tokyo, Japan, 150-0001
        • Olympia Eye Hospital
  • Singapur
      • Singapore, Singapur, 119074
        • National University Hospital
      • Singapore, Singapur, 168751
        • Singapore Eye Research Institute
  • Ungarn
      • Budapest, Ungarn, 1133
        • Budapest Retina Associates Kft.
  • Vereinigte Staaten
    • California
      • Beverly Hills, California, Vereinigte Staaten, 90210
        • Thrive Health Research LLC
      • La Jolla, California, Vereinigte Staaten, 92093-0946
        • UCSD Shiley Eye Center
    • Kansas
      • Wichita, Kansas, Vereinigte Staaten, 67206
        • Grene Vision Group, LLC
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48105
        • University of Michigan, Kellogg Eye Center
      • Saint Joseph, Michigan, Vereinigte Staaten, 49085
        • Great Lakes Eye Care
    • New York
      • Great Neck, New York, Vereinigte Staaten, 11021
        • 'Northwell Health Physician Partners Ophthalmology
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97225
        • EyeHealth Northwest
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705-1169
        • Austin Retina Associates
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84102
        • Eyelid Center of Utah
    • West Virginia
      • Morgantown, West Virginia, Vereinigte Staaten, 26506
        • WVU Eye Institute
  • Österreich
      • Vienna, Österreich, 1090
        • Medizinische Universität Wien

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

- Klinische Diagnose einer Schilddrüsen-Augenerkrankung (TED) basierend auf CAS

Ausschlusskriterien:

  • Rückgang des CAS oder der Proptose um >= 2 Punkte bzw. >= 2 mm im Studienauge zwischen Screening und Studienbeginn (Tag 1)
  • Erfordernis eines sofortigen chirurgischen ophthalmologischen Eingriffs oder der Planung einer korrigierenden Operation oder Bestrahlung im Verlauf der Studie, nach Einschätzung des Prüfarztes
  • Identifizierte vorbestehende Augenerkrankung, die nach Einschätzung des Prüfarztes die Teilnahme an der Studie ausschließen oder die Interpretation der Studienergebnisse erschweren würde, einschließlich einer Hornhautdekompensation, die nicht auf eine medizinische Behandlung anspricht, und einschließlich Augenerkrankungen, die während der Studie wahrscheinlich eine verbotene Therapie erfordern
  • Jeder schwerwiegende medizinische Zustand oder jede Anomalie bei klinischen Labortests, die nach Einschätzung des Prüfarztes die sichere Teilnahme und den Abschluss der Studie einer Person ausschließt
  • Schwanger oder stillend oder Absicht, während der Studie oder innerhalb von 12 Wochen nach der letzten Satralizumab-Dosis schwanger zu werden

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Satralizumab
Im Teil I-Zeitraum erhalten die Teilnehmer alle 4 Wochen (alle 4 Wochen) Satralizumab, gefolgt von einer auf der Proptosis-Reaktion basierenden individuellen Behandlung in Teil II der Studie
Arzneimittel: Satralizumab
Satralizumab wird durch SC-Injektion verabreicht.
Placebo-Komparator: Placebo
In Teil I erhalten die Teilnehmer alle vier Wochen ein Placebo, gefolgt von einer auf der Proptosis-Reaktion basierenden individuellen Behandlung in Teil II der Studie
Arzneimittel: Placebo
Placebo wird durch SC-Injektion verabreicht

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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 has been reported. Percentages have been rounded off.
At Week 24

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Zeitfenster: 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 has 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
Zeitfenster: At Week 24
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Zeitfenster: At Week 24
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At Week 24
Percentages have been rounded off.
At Week 24
Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24
Zeitfenster: 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
Zeitfenster: 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 in Active TED Population With a ≥6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24
Zeitfenster: 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 in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 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
Zeitfenster: 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
Zeitfenster: 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.
At Week 24
Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
Zeitfenster: 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.
At Week 24
Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
Zeitfenster: 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).
At Week 24
Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye
Zeitfenster: At Week 48
Percentage of participants 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 Achieving Overall Response at Week 48
Zeitfenster: 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 Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline at Week 48
Zeitfenster: 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
Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
Zeitfenster: 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 With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL at Week 48
Zeitfenster: At 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.
At Week 48
Change From Baseline in Proptosis at Week 48
Zeitfenster: At Week 48
At Week 48
Percentage of Participants Requiring Surgical Intervention for TED up to Week 48
Zeitfenster: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Zeitfenster: From Week 24 to Week 48
From Week 24 to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Zeitfenster: From Baseline to Week 48
From Baseline to Week 48
Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48
Zeitfenster: Week 24, Week 48
Week 24, Week 48
Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48
Zeitfenster: Week 24, 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.
Week 24, Week 48
Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48
Zeitfenster: At Week 48
At Week 48
Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48
Zeitfenster: 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
Zeitfenster: From Week 24 to Week 48
From Week 24 to Week 48
Change in CAS From Week 24 to 48
Zeitfenster: 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 With a ≥6-point Improvement in the Visual Functioning and Appearance Subscale Score of the GO-QoL From Week 24 at Week 48
Zeitfenster: Week 24, 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.
Week 24, Week 48
Change From Baseline in Proptosis to Week 48
Zeitfenster: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in CAS to Week 48
Zeitfenster: Baseline up 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 up to Week 48
Number of Participants With Adverse Events (AEs)
Zeitfenster: 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
Zeitfenster: Baseline, Weeks 2, 4, 8, 12 and 24
Baseline, Weeks 2, 4, 8, 12 and 24
Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study
Zeitfenster: Up to Week 48
Up to Week 48

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Ermittler

  • Studienleiter: Clinical Trials, Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Oktober 2023

Primärer Abschluss (Tatsächlich)

8. Juli 2025

Studienabschluss (Tatsächlich)

25. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. August 2023

Zuerst gepostet (Tatsächlich)

14. August 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GP44467
  • 2023-503309-13-00 (Ctis: EU CT Number)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über die Anfrageplattform (www.vivli.org) Zugriff auf Daten auf individueller Patientenebene anfordern. Weitere Einzelheiten zu den Roche-Kriterien für förderfähige Studien finden Sie hier (https://vivli.org/ourmember/roche/).

Weitere Einzelheiten zur globalen Richtlinie von Roche zur Weitergabe klinischer Informationen und zur Beantragung des Zugriffs auf entsprechende klinische Studiendokumente finden Sie hier (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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