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Une étude pour évaluer l'efficacité, l'innocuité, la pharmacocinétique et la pharmacodynamique du satralizumab chez les participants atteints de maladie oculaire thyroïdienne (SatraGO-1)

7 juillet 2026 mis à jour par: Hoffmann-La Roche

Une étude de phase III, randomisée, en double insu, contrôlée par placebo et multicentrique pour évaluer l'efficacité, l'innocuité, la pharmacocinétique et la pharmacodynamique du satralizumab chez des participants atteints d'une maladie oculaire thyroïdienne modérée à sévère

Le but de cette étude est d'évaluer l'efficacité, l'innocuité, la pharmacocinétique et la pharmacodynamique du satralizumab sous-cutané, un anticorps monoclonal recombinant anti-interleukine-6 ​​(IL-6) humanisé, chez des participants atteints de maladie oculaire thyroïdienne (TED).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

131

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

- Diagnostic clinique de la maladie oculaire thyroïdienne (TED) basé sur CAS

Critère d'exclusion:

  • Diminution du CAS ou de l'exophtalmie de >= 2 points ou >= 2 mm, respectivement, dans l'œil de l'étude entre le dépistage et la ligne de base de l'étude (jour 1)
  • Nécessitant une intervention chirurgicale ophtalmologique immédiate ou prévoyant une chirurgie corrective ou une irradiation au cours de l'étude, au jugement de l'investigateur
  • Maladie ophtalmique préexistante identifiée qui, de l'avis de l'investigateur, empêcherait la participation à l'étude ou compliquerait l'interprétation des résultats de l'étude, y compris la décompensation cornéenne insensible à la prise en charge médicale et y compris les maladies ophtalmiques qui nécessiteront probablement un traitement interdit pendant l'étude
  • Toute condition médicale grave ou anomalie dans les tests de laboratoire clinique qui, selon le jugement de l'investigateur, empêche la participation en toute sécurité d'un individu et l'achèvement de l'étude
  • Enceinte ou allaitante, ou intention de devenir enceinte pendant l'étude ou dans les 12 semaines après la dernière dose de satralizumab

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Satralizumab
Au cours de la période de la partie I, les participants recevront du satralizumab toutes les 4 semaines (q4w) suivi d'un traitement individualisé basé sur la réponse à la proptose dans la partie II de l'étude
Médicament: Satralizumab
Le satralizumab sera administré par injection SC.
Comparateur placebo: Placebo
Au cours de la période de la première partie, les participants recevront un placebo toutes les 4 semaines, suivi d'un traitement individualisé basé sur la réponse à l'exophtalmie dans la partie II de l'étude.
Médicament: Placebo
Le placebo sera administré par injection SC

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: At Week 24
Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
At Week 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Délai: At Week 24
Percentage of participants in the overall population (i.e., participants with active and chronic inactive TED) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.
At Week 24
Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye
Délai: At Week 24
At Week 24
Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye
Délai: At Week 24
At Week 24
Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24
Délai: 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
Délai: 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
Délai: At Week 24
Percentages have been rounded off.
At Week 24
Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24
Délai: 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
Délai: At Week 24
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population With a ≥6-point Improvement in the Appearance Subscale of the GO-QoL From Baseline at Week 24
Délai: At Week 24
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL. Percentages have been rounded off.
At Week 24
Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye at Week 24
Délai: 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
Délai: 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
Délai: At Week 24
CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms. Percentages have been rounded off.
At Week 24
Percentage of Participants With a ≥10-point Improvement in the Ocular Surface Disease Index (OSDI) Overall Scores Across All Levels of Baseline Severity at Week 24 in Overall Population
Délai: 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
Délai: At Week 24
The OSDI instrument is a validated dry eye questionnaire and consists of three main sections concerning ocular symptoms, visual function, and environmental factors. It comprises of 12 questions and for every question, participants select a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals of score ranging from 0 to 100. Higher scores represent a worse disease index.
At Week 24
Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population
Délai: At Week 24
Corneal staining was graded using Oxford Corneal Staining Chart which consists of a 6-point scale. Staining assessment will be based on the intensity of fluorescein staining, ranging from Grade 0 to V for each panel (0=absent; I=minimal; II=mild; III=moderate; IV= marked; and V=severe). Higher grade indicates worse disease index. The observer compares the overall appearance of the participant's corneal staining with the reference figure in the protocol. The observer selects the appropriate grade that best represents the state of corneal staining. The staining score were recorded for the exposed interpalpebral cornea and conjunctiva.
At Week 24
Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population
Délai: At Week 24
The percentage of participants achieving a complete binocular diplopia response (diplopia score=0) at Week 24 have been reported. Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
At Week 24
Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye
Délai: At Week 48
Percentage of participants who will achieve a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 48 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye will be reported.
At Week 48
Percentage of Participants Achieving Overall Response at Week 48
Délai: At Week 48
Overall Response is defined as a ≥ 2-point reduction in CAS, and a ≥ 2 mm reduction in proptosis from baseline in the study eye, provided there is no corresponding deterioration in CAS or proptosis ( ≥ 2-point/mm increase) in the fellow eye. The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
At Week 48
Percentage of Participants Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline at Week 48
Délai: At Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
At Week 48
Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0
Délai: At Week 48
Diplopia grade was assessed with the use of the Gorman subjective diplopia score (range: 0-3 points), which included: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3).
At Week 48
Percentage of Participants With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL at Week 48
Délai: At Week 48
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
At Week 48
Change From Baseline in Proptosis at Week 48
Délai: At Week 48
At Week 48
Percentage of Participants Requiring Surgical Intervention for TED up to Week 48
Délai: Up to Week 48
Up to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48
Délai: From Week 24 to Week 48
From Week 24 to Week 48
Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48
Délai: From Baseline to Week 48
From Baseline to Week 48
Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48
Délai: Week 24, Week 48
Week 24, Week 48
Percentage of Participants With Maintenance of CAS Response From Week 24 at Week 48
Délai: Week 24, Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Week 24, Week 48
Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48
Délai: At Week 48
At Week 48
Percentage of Participants With Maintenance of CAS Response From Baseline at Week 48
Délai: 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
Délai: From Week 24 to Week 48
From Week 24 to Week 48
Change in CAS From Week 24 to 48
Délai: From Week 24 to Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
From Week 24 to Week 48
Percentage of Participants With a ≥6-point Improvement in the Visual Functioning and Appearance Subscale Score of the GO-QoL From Week 24 at Week 48
Délai: Week 24, Week 48
The GO-QoL is a 16-item self-administered questionnaire divided into two sub-scales and used to assess the perceived effects of TED by the participants on their: 1) Visual Functioning (questions 1-8); and 2) Appearance (questions 9-16). Both subscales and overall score (sum of scores from all 16 questions) are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
Week 24, Week 48
Change From Baseline in Proptosis to Week 48
Délai: Baseline up to Week 48
Baseline up to Week 48
Change From Baseline in CAS to Week 48
Délai: Baseline up to Week 48
The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to TED; 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active TED (ignore "equivocal" redness); 6. Chemosis; 7. Swelling of caruncle or plica. Each item is scored as 1 (present) or 0 (absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms). Higher scores indicate worse symptoms.
Baseline up to Week 48
Number of Participants With Adverse Events (AEs)
Délai: 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
Délai: Baseline, Weeks 2, 4, 8, 12 and 24
Baseline, Weeks 2, 4, 8, 12 and 24
Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study
Délai: Up to Week 48
Up to Week 48

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Les enquêteurs

  • Directeur d'études: Clinical Trials, Hoffmann-La Roche

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 octobre 2023

Achèvement primaire (Réel)

8 juillet 2025

Achèvement de l'étude (Réel)

25 juin 2026

Dates d'inscription aux études

Première soumission

5 juillet 2023

Première soumission répondant aux critères de contrôle qualité

4 août 2023

Première publication (Réel)

14 août 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Les chercheurs qualifiés peuvent demander l'accès aux données individuelles des patients via la plateforme de demande (www.vivli.org). De plus amples détails sur les critères de Roche pour les études éligibles sont disponibles ici (https://vivli.org/ourmember/roche/).

Pour plus de détails sur la politique mondiale de Roche sur le partage des informations cliniques et sur la façon de demander l'accès aux documents d'études cliniques connexes, voir ici (https://www.roche.com/innovation/process/clinical-trials/data-sharing/) .

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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