En undersøgelse til evaluering af Satralizumabs effektivitet, sikkerhed, farmakokinetik og farmakodynamik hos deltagere med skjoldbruskkirteløjensygdom (SatraGO-2) (SatraGO-2)
20. juli 2026 opdateret af: Hoffmann-La Roche
En fase III, randomiseret, dobbeltmaskeret, placebokontrolleret, multicenterundersøgelse til evaluering af Satralizumabs effektivitet, sikkerhed, farmakokinetik og farmakodynamik hos deltagere med moderat til svær skjoldbruskkirteløjensygdom
Formålet med denne undersøgelse er at vurdere effektiviteten, sikkerheden, farmakokinetikken og farmakodynamikken af subkutan satralizumab, et rekombinant, humaniseret anti-interleukin-6 (IL-6) receptor monoklonalt antistof, hos deltagere med thyroid øjensygdom (TED).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
127
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Edmonton, Alberta, Canada
- University of Alberta
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Ontario
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Toronto, Ontario, Canada, M3C 0G9
- Toronto Retina Institute
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Universite de Montreal - Hopital Maisonneuve-Rosemont
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Brighton, Det Forenede Kongerige, BN2 5BF
- Sussex Eye Hospital
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Bristol, Det Forenede Kongerige, BS1 2LX
- Bristol Eye Hospital
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Glasgow, Det Forenede Kongerige, G12 0YN
- Gartnavel General Hospital
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Leeds, Det Forenede Kongerige, LS9 7TF
- St James University Hospital
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Liverpool, Det Forenede Kongerige, L7 8XP
- Royal Liverpool University Hospital
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London, Det Forenede Kongerige, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Maidstone, Kent, Det Forenede Kongerige, ME16 9QQ
- Maidstone Hospital
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California
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San Diego, California, Forenede Stater, 92108
- Plastics-Orbit-Neuro
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Connecticut Eye Consultants, P.C.
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois Eye and Ear Infirmary
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Scheie Eye Institute
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-8808
- Vanderbilt Eye Institute
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Texas
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San Antonio, Texas, Forenede Stater, 78251
- Retina Consultants of Texas
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Nantes, Frankrig, 44093
- CHU Nantes - Hôtel Dieu
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Paris, Frankrig, 75019
- Fondation Rothschild
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Paris, Frankrig, 75012
- CHNO Hopital des Quinze Vingts
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Jerusalem, Israel, 9112001
- Hadassah MC
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Petah Tikva, Israel, 4941492
- Rabin MC
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Ramat Gan, Israel
- Sheba medical center
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Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Kina, 100032
- Peking Union Medical College Hospital
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Beijing, Kina, 100730
- Beijing Hospital of Ministry of Health
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Beijing, Kina, 100730
- Beijing Tongren Hospital, Capital Medical University
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Xi'an, Kina, 710004
- Xi'an Fourth Hospital
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Bydgoszcz, Polen, 85-316
- Specjalistyczny Osrodek Okulistyczny Oculomedica
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Gdansk, Polen, 80-180
- Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
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Coimbra, Portugal, 3000-548
- AIBILI - Association for Innovation and Biomedical Research on Light
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Barcelona, Spanien, 08035
- Hospital Universitario Vall D hebron
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Granada, Spanien, 18012
- Hospital Universitario Virgen de las Nieves
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Madrid, Spanien, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Spanien, 28031
- Hospital Ramon y Cajal
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Seville, Spanien, 41007
- Hospital Universitario Virgen De La Macarena
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Valencia, Spanien, 46026
- Hospital Universitario la Fe: Servicio de Oftalmologia
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spanien, 8907
- Hospital Universitari de Bellvitge
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Seongnam-si, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 003-722
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea, 135-710
- Samsung Medical Center
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Seoul, Sydkorea, 06973
- Chung-Ang University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Klinisk diagnose af thyreoidea øjensygdom (TED) baseret på CAS
Ekskluderingskriterier:
- Fald i CAS eller proptose på henholdsvis >= 2 point eller >= 2 mm i undersøgelsesøjet mellem screening og undersøgelsens baseline (dag 1)
- Kræver øjeblikkelig kirurgisk oftalmologisk intervention eller planlægning af korrigerende kirurgi eller bestråling i løbet af undersøgelsen, efter investigators vurdering
- Identificeret allerede eksisterende oftalmisk sygdom, der efter investigatorens vurdering ville udelukke undersøgelsesdeltagelse eller komplicere fortolkning af undersøgelsesresultater, herunder hornhindekompensation, der ikke reagerer på medicinsk behandling, og herunder øjensygdomme, der sandsynligvis vil kræve forbudt behandling under undersøgelsen
- Enhver alvorlig medicinsk tilstand eller abnormitet i kliniske laboratorietests, der efter investigatorens vurdering udelukker en persons sikre deltagelse i og fuldførelse af undersøgelsen
- Gravid eller ammende, eller intention om at blive gravid under undersøgelsen eller inden for 12 uger efter den sidste dosis af satralizumab
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Satralizumab
I del I-perioden vil deltagerne modtage satralizumab hver 4. uge (q4w) efterfulgt af proptose-respons-baseret individualiseret behandling i del II af undersøgelsen.
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Satralizumab vil blive administreret ved subkutan injektion.
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Placebo komparator: Placebo
I del I-perioden vil deltagerne modtage placebo q4w efterfulgt af proptose-respons-baseret individualiseret behandling i del II af undersøgelsen.
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Placebo vil blive indgivet ved subkutan injektion
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Tidsramme: At Week 24
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Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye have been reported.
Percentages have been rounded off.
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At Week 24
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Tidsramme: At Week 24
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Participants with active TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Tidsramme: At Week 24
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Participants with active and chronic inactive TED with diplopia present at baseline who had Grade ≥1 reduction or improvement at Week 24 have been reported.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24
Tidsramme: At Week 24
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Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
Tidsramme: At Week 24
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Overall Response was defined as a ≥ 2-point reduction in clinical activity score (CAS), and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis (≥ 2-point/mm increase) in the fellow eye.
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 24
Tidsramme: At Week 24
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CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye at Week 24
Tidsramme: At Week 24
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CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
Percentages have been rounded off.
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At Week 24
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Number of Participants With Adverse Events (AEs)
Tidsramme: Up to Week 72
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An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
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Up to Week 72
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Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints
Tidsramme: Baseline, Weeks 2, 4, 8, 12 and 24
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Baseline, Weeks 2, 4, 8, 12 and 24
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Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Tidsramme: At Week 24
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Percentage of participants in the overall population (i.e., participants with active and chronic inactive TED) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye have been reported.
Percentages have been rounded off.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
Tidsramme: At Week 24
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This analysis used a Mixed-effects Model for Repeated Measure (MMRM) model.
Adjusted mean values have been reported here.
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At Week 24
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Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Tidsramme: At Week 24
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This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Percentage of Participants in Active TED Population Achieving Absence of Spontaneous Pain at Week 24
Tidsramme: At Week 24
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Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Visual Functioning Subscale of the Graves' Ophthalmopathy Quality-of-life (GO-QoL) From Baseline at Week 24
Tidsramme: At Week 24
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales, and is used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants in Active TED Population With a ≥ 6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24
Tidsramme: At Week 24
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
Percentages have been rounded off.
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At Week 24
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Percentage of Participants With a ≥ 10-point Improvement in the Ocular Surface Disease Index (OSDI) Overall Scores Across All Levels of Baseline Severity at Week 24 in Overall Population
Tidsramme: At Week 24
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The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors.
It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100.
Higher scores represent a worse disease index.
Percentages have been rounded off.
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At Week 24
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Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population
Tidsramme: At Week 24
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The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors.
It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100.
Higher scores represent a worse disease index.
This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
Tidsramme: At Week 24
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Corneal staining was graded using Oxford Corneal Staining Chart which consists of a 6-point scale.
Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (0=absent; I=minimal; II=mild; III=moderate; IV= marked; and V=severe).
Higher grade indicates worse disease index.
The observer compares the overall appearance of the participant's corneal staining with the reference figure in the protocol.
The observer selects the appropriate grade that best represents the state of corneal staining.
The staining score were recorded for the exposed interpalpebral cornea and conjunctiva.
This analysis used a MMRM model.
Adjusted mean values have been reported here.
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At Week 24
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Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
Tidsramme: At Week 24
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The percentage of participants achieving a complete binocular diplopia response (diplopia score=0) at Week 24 have been reported.
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
Percentages have been rounded off.
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At Week 24
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving ≥ 2 mm Reduction in Proptosis at Week 48 in the Study Eye
Tidsramme: At Week 48
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Percentage of participants (proptosis non-responders) who will achieve a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 48 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye will be reported.
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At Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving Overall Response at Week 48
Tidsramme: At Week 48
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Overall Response is defined as a ≥ 2-point reduction in CAS, and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis ( ≥ 2-point/mm increase) in the fellow eye.
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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At Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to Week 48
Tidsramme: Baseline to Week 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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Baseline to Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
Tidsramme: At Week 48
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Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
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At Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
Tidsramme: From Week 24 to Week 48
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
Tidsramme: From baseline up to Week 48
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
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From baseline up to Week 48
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Change From Baseline in Proptosis at Week 48 (in Proptosis Non-responders at Week 24)
Tidsramme: Baseline and Week 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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Baseline and Week 48
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Percentage of Participants (Proptosis Non-responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Tidsramme: Up to Week 48
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Up to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Tidsramme: From Week 24 to Week 48
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Tidsramme: Baseline to Week 48
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Baseline to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Week 24 at Week 48
Tidsramme: Weeks 24 and 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Week 24 at Week 48
Tidsramme: Weeks 24 and 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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Weeks 24 and 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of Proptosis Response From Baseline at Week 48
Tidsramme: At Week 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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At Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With Maintenance of CAS Response From Baseline at Week 48
Tidsramme: At Week 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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At Week 48
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Change in Proptosis From Week 24 to 48 (in Proptosis Responders at Week 24)
Tidsramme: From Week 24 to Week 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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From Week 24 to Week 48
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Change in CAS From Week 24 to 48 (in Proptosis Responders at Week 24)
Tidsramme: From Week 24 to Week 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Week 24 to Week 48
Tidsramme: From Week 24 to Week 48
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
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From Week 24 to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL From Baseline to Week 48
Tidsramme: From baseline up to Week 48
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The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16).
Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100.
Higher total scores indicate better QoL.
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From baseline up to Week 48
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Change From Baseline in Proptosis to Week 48 (in Proptosis Responders at Week 24)
Tidsramme: Baseline to Week 48
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Proptosis response is defined as achieving a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye.
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Baseline to Week 48
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Change From Baseline in CAS to Week 48 (in Proptosis Responders at Week 24)
Tidsramme: Baseline to Week 48
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The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica.
Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms).
Higher scores indicate worse symptoms.
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Baseline to Week 48
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Percentage of Participants (Proptosis Responders at Week 24) Requiring Surgical Intervention for TED up to Week 48
Tidsramme: Up to Week 48
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Up to Week 48
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Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Tidsramme: Up to Week 48
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Participants will be considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response).
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Up to Week 48
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. november 2023
Primær færdiggørelse (Faktiske)
24. juli 2025
Studieafslutning (Faktiske)
25. juni 2026
Datoer for studieregistrering
Først indsendt
25. oktober 2023
Først indsendt, der opfyldte QC-kriterier
25. oktober 2023
Først opslået (Faktiske)
30. oktober 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Genetiske sygdomme, medfødte
- Autoimmune sygdomme
- Sygdomme i immunsystemet
- Øjensygdomme
- Øjensygdomme, arvelig
- Graves sygdom
- Eksophthalmos
- Orbitale sygdomme
- Struma
- Hyperthyroidisme
- Skjoldbruskkirtelsygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Graves Oftalmopati
- Saturralizumab
Andre undersøgelses-id-numre
- GP44729
- 2023-503669-50-00 (Ctis: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalificerede forskere kan anmode om adgang til individuelle data på patientniveau gennem anmodningsplatformen (www.vivli.org). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/ourmember/roche/).
For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .