En studie för att utvärdera effektiviteten, säkerheten, farmakokinetiken och farmakodynamiken hos Satralizumab hos deltagare med sköldkörtelögonsjukdom (SatraGO-2) (SatraGO-2)
20 juli 2026 uppdaterad av: Hoffmann-La Roche
En fas III, randomiserad, dubbelmaskad, placebokontrollerad, multicenterstudie för att utvärdera effektiviteten, säkerheten, farmakokinetiken och farmakodynamiken hos Satralizumab hos deltagare med måttlig till svår sköldkörtelögonsjukdom
Syftet med denna studie är att bedöma effektiviteten, säkerheten, farmakokinetiken och farmakodynamiken för subkutan satralizumab, en rekombinant, humaniserad monoklonal anti-interleukin-6 (IL-6) receptor antikropp, hos deltagare med sköldkörtelögonsjukdom (TED).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
127
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Nantes, Frankrike, 44093
- CHU Nantes - Hôtel Dieu
-
Paris, Frankrike, 75019
- Fondation Rothschild
-
Paris, Frankrike, 75012
- CHNO Hopital des Quinze Vingts
-
-
-
-
California
-
San Diego, California, Förenta staterna, 92108
- Plastics-Orbit-Neuro
-
-
Connecticut
-
Danbury, Connecticut, Förenta staterna, 06810
- Connecticut Eye Consultants, P.C.
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- University of Illinois Eye and Ear Infirmary
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Scheie Eye Institute
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37232-8808
- Vanderbilt Eye Institute
-
-
Texas
-
San Antonio, Texas, Förenta staterna, 78251
- Retina Consultants of Texas
-
-
-
-
-
Jerusalem, Israel, 9112001
- Hadassah MC
-
Petah Tikva, Israel, 4941492
- Rabin MC
-
Ramat Gan, Israel
- Sheba medical center
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada
- University of Alberta
-
-
Ontario
-
Toronto, Ontario, Kanada, M3C 0G9
- Toronto Retina Institute
-
-
Quebec
-
Montreal, Quebec, Kanada, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont
-
-
-
-
-
Beijing, Kina, 100191
- Peking University Third Hospital
-
Beijing, Kina, 100032
- Peking Union Medical College Hospital
-
Beijing, Kina, 100730
- Beijing Hospital of Ministry of Health
-
Beijing, Kina, 100730
- Beijing Tongren Hospital, Capital Medical University
-
Xi'an, Kina, 710004
- Xi'an Fourth Hospital
-
-
-
-
-
Bydgoszcz, Polen, 85-316
- Specjalistyczny Osrodek Okulistyczny Oculomedica
-
Gdansk, Polen, 80-180
- Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
-
-
-
-
-
Coimbra, Portugal, 3000-548
- AIBILI - Association for Innovation and Biomedical Research on Light
-
-
-
-
-
Barcelona, Spanien, 08035
- Hospital Universitario Vall D hebron
-
Granada, Spanien, 18012
- Hospital Universitario Virgen de las Nieves
-
Madrid, Spanien, 28040
- Hospital Universitario Clinico San Carlos
-
Madrid, Spanien, 28031
- Hospital Ramon y Cajal
-
Seville, Spanien, 41007
- Hospital Universitario Virgen De La Macarena
-
Valencia, Spanien, 46026
- Hospital Universitario la Fe: Servicio de Oftalmologia
-
-
Barcelona
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 8907
- Hospital Universitari de Bellvitge
-
-
-
-
-
Brighton, Storbritannien, BN2 5BF
- Sussex Eye Hospital
-
Bristol, Storbritannien, BS1 2LX
- Bristol Eye Hospital
-
Glasgow, Storbritannien, G12 0YN
- Gartnavel General Hospital
-
Leeds, Storbritannien, LS9 7TF
- St James University Hospital
-
Liverpool, Storbritannien, L7 8XP
- Royal Liverpool University Hospital
-
London, Storbritannien, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
-
Maidstone, Kent, Storbritannien, ME16 9QQ
- Maidstone Hospital
-
-
-
-
-
Seongnam-si, Sydkorea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Sydkorea, 003-722
- Severance Hospital, Yonsei University Health System
-
Seoul, Sydkorea, 135-710
- Samsung Medical Center
-
Seoul, Sydkorea, 06973
- Chung-Ang University Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Klinisk diagnos av sköldkörtelögonsjukdom (TED) baserad på CAS
Exklusions kriterier:
- En minskning av CAS eller proptos med >= 2 poäng respektive >= 2 mm i studieögat mellan screening och studiebaslinje (dag 1)
- Kräver omedelbar kirurgisk oftalmologisk intervention eller planerar korrigerande kirurgi eller bestrålning under studiens gång, enligt utredarens bedömning
- Identifierad redan existerande oftalmisk sjukdom som, enligt utredarens bedömning, skulle förhindra studiedeltagande eller komplicera tolkning av studieresultat, inklusive hornhinnedekompensation som inte svarar på medicinsk behandling och inklusive oftalmiska sjukdomar som sannolikt kommer att kräva förbjuden terapi under studien
- Alla allvarliga medicinska tillstånd eller abnormiteter i kliniska laboratorietester som, enligt utredarens bedömning, utesluter en individs säker deltagande i och slutförande av studien
- Gravid eller ammande, eller avsikt att bli gravid under studien eller inom 12 veckor efter den sista dosen av satralizumab
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Satralizumab
Under del I-perioden kommer deltagarna att få satralizumab var fjärde vecka (q4w) följt av proptossvarsbaserad individuell behandling i del II av studien.
|
Satralizumab kommer att administreras genom subkutan injektion.
|
|
Placebo-jämförare: Placebo
Under del I-perioden kommer deltagarna att få placebo q4w följt av proptossvarsbaserad individualiserad behandling i del II av studien.
|
Placebo kommer att administreras genom SC-injektion
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Up to Week 48
|
Up to Week 48
|
|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Trials, Hoffmann-La Roche
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 november 2023
Primärt slutförande (Faktisk)
24 juli 2025
Avslutad studie (Faktisk)
25 juni 2026
Studieregistreringsdatum
Först inskickad
25 oktober 2023
Först inskickad som uppfyllde QC-kriterierna
25 oktober 2023
Första postat (Faktisk)
30 oktober 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Genetiska sjukdomar, medfödda
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Ögonsjukdomar
- Ögonsjukdomar, ärftliga
- Graves sjukdom
- Exoftalmos
- Orbitala sjukdomar
- Struma
- Hypertyreos
- Sköldkörtelsjukdomar
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Graves Oftalmopati
- satralizumab
Andra studie-ID-nummer
- GP44729
- 2023-503669-50-00 (Ctis: EU CT Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Kvalificerade forskare kan begära tillgång till data på individuell patientnivå via begärandeplattformen (www.vivli.org). Ytterligare information om Roches kriterier för kvalificerade studier finns här (https://vivli.org/ourmember/roche/).
För ytterligare information om Roches globala policy för delning av klinisk information och hur man begär åtkomst till relaterade kliniska studiedokument, se här (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .