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Thyroid Eye DiseasePhase 3SatraGO-1NCT05987423

Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

A Phase 3 study testing Satralizumab in people with Thyroid Eye Disease and TED, run by Hoffmann-La Roche at 46 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Eye Disease, TED
What is being tested?
Satralizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
46 sitesin 10 countries
Study dates
26 Oct 2023to 25 Jun 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of TED based on CAS

Who cannot join

  • Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
  • Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
  • Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab

Trial locations and contacts

46 sites in 10 countries.

46 sites in 10 countries

United States11 sites
  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105

  • Austin Retina Associates

    Austin, Texas, 78705-1169

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Thrive Health Research LLC

    Beverly Hills, California, 90210

  • 'Northwell Health Physician Partners Ophthalmology

    Great Neck, New York, 11021

  • UCSD Shiley Eye Center

    La Jolla, California, 92093-0946

  • WVU Eye Institute

    Morgantown, West Virginia, 26506

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Great Lakes Eye Care

    Saint Joseph, Michigan, 49085

  • Eyelid Center of Utah

    Salt Lake City, Utah, 84102

  • Grene Vision Group, LLC

    Wichita, Kansas, 67206

Other trials in United States

Japan10 sites
  • Aichi Medical University Hospital

    Aichi, 480-1195

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Social Medical Corporation Tenjinkai Shinkoga Hospital

    Fukuoka, 830-8577

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe Kaisei Hospital Medical foundation

    Hyōgo, 657-0068

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8556

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Olympia Eye Hospital

    Tokyo, 150-0001

Other trials in Japan

Argentina6 sites
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1015ABO

  • Oftalmos

    Capital Federal, C1120AAN

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE

  • Centrovision Mendoza

    Mendoza, M5500BWG

  • Grupo Laser Vision

    Rosario, S2000DLA

Other trials in Argentina

Germany6 sites
  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Munster

    Münster, 48149

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076

Other trials in Germany

Italy5 sites
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy

  • A.O. U. Federico II

    Naples, Campania, 80131

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Lombardy, 21100

Other trials in Italy

Australia3 sites
  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

Other trials in Australia

Singapore2 sites
  • National University Hospital

    Singapore, 119074

  • Singapore Eye Research Institute

    Singapore, 168751

Other trials in Singapore

Austria1 site
  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Hong Kong1 site
  • Hong Kong Eye Hospital

    Mong Kok

Other trials in Hong Kong

Hungary1 site
  • Budapest Retina Associates Kft.

    Budapest, 1133

Other trials in Hungary

About this study

Official title: A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Being tested
Satralizumab, Placebo
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SatralizumabDrug

    Satralizumab will be administered by SC injection.

  • PlaceboDrug

    Placebo will be administered by SC injection

Study groups in NCT05987423
Study groupRoleWhat they receive
SatralizumabExperimentalIn the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study
Receives: Drug: Satralizumab
PlaceboPlacebo comparatorIn the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: At Week 24

Secondary outcomes (37)
  1. Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye

    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.

    Measured: At Week 24

  2. Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye

    Measured: At Week 24

  3. Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye

    Measured: At Week 24

  4. Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia 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.

    Measured: At Week 24

  5. Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia 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.

    Measured: At Week 24

  6. Percentage of Participants in Active TED Population Achieving Absence of Motility-induced Pain at Week 24

    Percentages have been rounded off.

    Measured: At Week 24

  7. Percentage of Participants Active TED Population Achieving Absence of Spontaneous Pain at Week 24

    Percentages have been rounded off.

    Measured: At Week 24

  8. 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

    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.

    Measured: At Week 24

  9. 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

    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.

    Measured: At Week 24

  10. Percentage of Participants in Active TED Population Who Achieved Overall Response in the Study Eye 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.

    Measured: At Week 24

  11. Percentage of Participants in Active TED Population Who Achieved a ≥ 2-point Reduction in CAS in the Study Eye From Baseline to 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.

    Measured: At Week 24

  12. Percentage of Participants in Active TED Population Who Achieved a CAS Value of 0 or 1 in the Study Eye 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.

    Measured: At Week 24

  13. 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

    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.

    Measured: At Week 24

  14. Change From Baseline in the OSDI Ocular Symptoms, and Vision-related Function Subscale Scores at Week 24 in the Overall Population

    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.

    Measured: At Week 24

  15. Change From Baseline in Oxford Corneal Staining Scores at Week 24 in the Overall Population

    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.

    Measured: At Week 24

  16. Percentage of Participants Who Achieved Complete Binocular Diplopia Response at Week 24 in Overall Population

    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).

    Measured: At Week 24

  17. Percentage of Participants Achieving ≥2 mm Reduction in Proptosis at Week 48 in the Study Eye

    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.

    Measured: At Week 48

  18. Percentage of Participants Achieving Overall Response 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.

    Measured: At Week 48

  19. Percentage of Participants Achieving a ≥ 2-point Reduction in CAS in the Study Eye From Baseline 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.

    Measured: At Week 48

  20. Percentage of Participants Achieving Grade ≥ 1 Reduction/Improvement in Diplopia at Week 48 in Participants With Baseline Diplopia > 0

    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).

    Measured: At Week 48

  21. Percentage of Participants With a ≥ 6-point Improvement in the Visual Functioning and Appearance Subscale Scores of the GO-QoL 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.

    Measured: At Week 48

  22. Change From Baseline in Proptosis at Week 48

    Measured: At Week 48

  23. Percentage of Participants Requiring Surgical Intervention for TED up to Week 48

    Measured: Up to Week 48

  24. Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Week 24 to Week 48

    Measured: From Week 24 to Week 48

  25. Percentage of Participants With Worsening of Proptosis by ≥ 2 mm From Baseline to Week 48

    Measured: From Baseline to Week 48

  26. Percentage of Participants With Maintenance of Proptosis Response From Week 24 at Week 48

    Measured: Week 24, Week 48

  27. Percentage of Participants With Maintenance of CAS Response From Week 24 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.

    Measured: Week 24, Week 48

  28. Percentage of Participants With Maintenance of Proptosis Response From Baseline at Week 48

    Measured: At Week 48

  29. Percentage of Participants With Maintenance of CAS Response From Baseline 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.

    Measured: At Week 48

  30. Change in Proptosis From Week 24 to 48

    Measured: From Week 24 to Week 48

  31. Change in CAS From Week 24 to 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.

    Measured: From Week 24 to Week 48

  32. 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

    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.

    Measured: Week 24, Week 48

  33. Change From Baseline in Proptosis to Week 48

    Measured: Baseline up to Week 48

  34. Change From Baseline in CAS 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.

    Measured: Baseline up to Week 48

  35. Number of Participants With Adverse Events (AEs)

    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.

    Measured: Up to Week 72

  36. Serum Trough Concentration (Ctrough) of Satralizumab at Specified Timepoints

    Measured: Baseline, Weeks 2, 4, 8, 12 and 24

  37. Number of Participants With Anti-drug Antibody to Satralizumab at Baseline and During the Study

    Measured: Up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start26 Oct 2023
  3. Primary completion8 Jul 2025
  4. Study completion25 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05987423
Sponsor's protocol ID
GP44467
Other IDs
2023-503309-13-00, 2023
Acronym
SatraGO-1
Status last verified
Jul 2026
First submitted
5 Jul 2023
Last updated
31 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Ezra D, Collins A, Haskova Z, Kuenzel T, Ida H, Triyatni M, Brittain C, Idowu O. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025 Dec;14(12):3119-3132. doi: 10.1007/s40123-025-01255-3. Epub 2025 Oct 9.

    PubMed 41066062

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