En studie for å evaluere effekten, sikkerheten, farmakokinetikken og farmakodynamikken til Satralizumab hos deltakere med skjoldbruskkjerteløyesykdom (SatraGO-2) (SatraGO-2)
20. juli 2026 oppdatert av: Hoffmann-La Roche
En fase III, randomisert, dobbeltmasket, placebokontrollert, multisenterstudie for å evaluere effekten, sikkerheten, farmakokinetikken og farmakodynamikken til Satralizumab hos deltakere med moderat til alvorlig skjoldbruskkjerteløyesykdom
Hensikten med denne studien er å vurdere effektiviteten, sikkerheten, farmakokinetikken og farmakodynamikken til subkutan satralizumab, et rekombinant, humanisert anti-interleukin-6 (IL-6) reseptor monoklonalt antistoff, hos deltakere med skjoldbrusk øyesykdom (TED).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
127
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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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California
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San Diego, California, Forente stater, 92108
- Plastics-Orbit-Neuro
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Connecticut
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Danbury, Connecticut, Forente stater, 06810
- Connecticut Eye Consultants, P.C.
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois Eye and Ear Infirmary
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Scheie Eye Institute
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Tennessee
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Nashville, Tennessee, Forente stater, 37232-8808
- Vanderbilt Eye Institute
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Texas
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San Antonio, Texas, Forente stater, 78251
- Retina Consultants of Texas
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Nantes, Frankrike, 44093
- CHU Nantes - Hôtel Dieu
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Paris, Frankrike, 75019
- Fondation Rothschild
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Paris, Frankrike, 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, Spania, 08035
- Hospital Universitario Vall D hebron
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Granada, Spania, 18012
- Hospital Universitario Virgen de las Nieves
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Madrid, Spania, 28040
- Hospital Universitario Clinico San Carlos
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Madrid, Spania, 28031
- Hospital Ramon y Cajal
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Seville, Spania, 41007
- Hospital Universitario Virgen De La Macarena
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Valencia, Spania, 46026
- Hospital Universitario la Fe: Servicio de Oftalmologia
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spania, 8907
- Hospital Universitari de Bellvitge
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Brighton, Storbritannia, BN2 5BF
- Sussex Eye Hospital
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Bristol, Storbritannia, BS1 2LX
- Bristol Eye Hospital
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Glasgow, Storbritannia, G12 0YN
- Gartnavel General Hospital
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Leeds, Storbritannia, LS9 7TF
- St James University Hospital
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Liverpool, Storbritannia, L7 8XP
- Royal Liverpool University Hospital
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London, Storbritannia, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Maidstone, Kent, Storbritannia, ME16 9QQ
- Maidstone Hospital
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Seongnam-si, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 003-722
- Severance Hospital, Yonsei University Health System
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Seoul, Sør -Korea, 135-710
- Samsung Medical Center
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Seoul, Sør -Korea, 06973
- Chung-Ang University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Klinisk diagnose av øyesykdom i skjoldbruskkjertelen (TED) basert på CAS
Ekskluderingskriterier:
- Nedgang i CAS eller proptose på henholdsvis >= 2 poeng eller >= 2 mm i studieøyet mellom screening og studiens baseline (dag 1)
- Krever umiddelbar kirurgisk oftalmologisk intervensjon eller planlegger korrigerende kirurgi eller bestråling i løpet av studien, etter etterforskerens vurdering
- Identifisert allerede eksisterende oftalmisk sykdom som, etter utforskerens vurdering, ville utelukke studiedeltakelse eller komplisere tolkning av studieresultater, inkludert hornhinnedekompensasjon som ikke reagerer på medisinsk behandling og inkludert oftalmiske sykdommer som sannsynligvis vil kreve forbudt behandling under studien
- Enhver alvorlig medisinsk tilstand eller abnormitet i kliniske laboratorietester som, etter etterforskerens vurdering, utelukker en persons trygge deltakelse i og fullføring av studien
- Gravid eller ammende, eller intensjon om å bli gravid under studien eller innen 12 uker etter den siste dosen av satralizumab
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Satralizumab
I del I-perioden vil deltakerne motta satralizumab hver 4. uke (q4w) etterfulgt av proptoseresponsbasert individualisert behandling i del II av studien.
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Satralizumab vil bli administrert ved subkutan injeksjon.
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Placebo komparator: Placebo
I del I-perioden vil deltakerne motta placebo q4w etterfulgt av proptoseresponsbasert individualisert behandling i del II av studien.
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Placebo vil bli administrert ved SC-injeksjon
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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
|
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
|
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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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2023
Primær fullføring (Faktiske)
24. juli 2025
Studiet fullført (Faktiske)
25. juni 2026
Datoer for studieregistrering
Først innsendt
25. oktober 2023
Først innsendt som oppfylte QC-kriteriene
25. oktober 2023
Først lagt ut (Faktiske)
30. oktober 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Genetiske sykdommer, medfødte
- Autoimmune sykdommer
- Sykdommer i immunsystemet
- Øyesykdommer
- Øyesykdommer, arvelig
- Graves 'sykdom
- Eksophthalmos
- Orbitale sykdommer
- Struma
- Hypertyreose
- Skjoldbrusk sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Graves Oftalmopati
- Satralizumab
Andre studie-ID-numre
- GP44729
- 2023-503669-50-00 (Ctis: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalifiserte forskere kan be om tilgang til individuelle pasientnivådata gjennom forespørselsplattformen (www.vivli.org). Ytterligere detaljer om Roches kriterier for kvalifiserte studier er tilgjengelig her (https://vivli.org/ourmember/roche/).
For ytterligere detaljer om Roches globale retningslinjer for deling av klinisk informasjon og hvordan du ber om tilgang til relaterte kliniske studiedokumenter, se her (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .