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Studie k hodnocení účinnosti, bezpečnosti, farmakokinetiky a farmakodynamiky satralizumabu u účastníků s onemocněním štítné žlázy (SatraGO-2) (SatraGO-2)

20. července 2026 aktualizováno: Hoffmann-La Roche

Randomizovaná, dvojitě maskovaná, placebem kontrolovaná, multicentrická studie fáze III k vyhodnocení účinnosti, bezpečnosti, farmakokinetiky a farmakodynamiky satralizumabu u účastníků se středně závažným až závažným onemocněním štítné žlázy

Účelem této studie je posoudit účinnost, bezpečnost, farmakokinetiku a farmakodynamiku subkutánního satralizumabu, rekombinantní, humanizované monoklonální protilátky proti receptoru interleukinu-6 (IL-6), u účastníků s onemocněním štítné žlázy (TED).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

127

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

- Klinická diagnostika onemocnění štítné žlázy (TED) na základě CAS

Kritéria vyloučení:

  • Snížení CAS nebo proptózy o >= 2 body, respektive >= 2 mm, ve studovaném oku mezi screeningem a výchozí hodnotou studie (1. den)
  • Požadavek okamžitého chirurgického oftalmologického zákroku nebo plánování korektivního chirurgického zákroku nebo ozáření v průběhu studie, podle úsudku zkoušejícího
  • Identifikované již existující oční onemocnění, které by podle úsudku zkoušejícího znemožnilo účast ve studii nebo zkomplikovalo interpretaci výsledků studie, včetně dekompenzace rohovky nereagující na lékařskou péči a včetně očních onemocnění, která budou pravděpodobně vyžadovat zakázanou léčbu během studie
  • Jakýkoli závažný zdravotní stav nebo abnormalita v klinických laboratorních testech, které podle úsudku zkoušejícího znemožňují bezpečnou účast jednotlivce ve studii a její dokončení
  • Těhotenství nebo kojení nebo úmysl otěhotnět během studie nebo do 12 týdnů po poslední dávce satralizumabu

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Satralizumab
V období části I budou účastníci dostávat satralizumab každé 4 týdny (q4w), po čemž bude následovat individualizovaná léčba založená na proptózové odpovědi v části II studie.
Lék: Satralizumab
Satralizumab bude podáván SC injekcí.
Komparátor placeba: Placebo
V části I období budou účastníci dostávat placebo q4w následované individualizovanou léčbou založenou na proptóze v části II studie.
Lék: Placebo
Placebo bude podáváno SC injekcí

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Up to Week 48
Up to Week 48
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab at Baseline and During the Study
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Vyšetřovatelé

  • Ředitel studie: Clinical Trials, Hoffmann-La Roche

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. listopadu 2023

Primární dokončení (Aktuální)

24. července 2025

Dokončení studie (Aktuální)

25. června 2026

Termíny zápisu do studia

První předloženo

25. října 2023

První předloženo, které splnilo kritéria kontroly kvality

25. října 2023

První zveřejněno (Aktuální)

30. října 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Kvalifikovaní výzkumní pracovníci mohou požádat o přístup k údajům na úrovni jednotlivých pacientů prostřednictvím platformy žádostí (www.vivli.org). Další podrobnosti o kritériích společnosti Roche pro způsobilé studie jsou k dispozici zde (https://vivli.org/ourmember/roche/).

Další podrobnosti o globální politice společnosti Roche pro sdílení klinických informací a o tom, jak požádat o přístup k souvisejícím dokumentům klinických studií, naleznete zde (https://www.roche.com/innovation/process/clinical-trials/data-sharing/). .

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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