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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified April 2026 by Hoffmann-La Roche
Sponsor
Hoffmann-La Roche
Information Provided by (Responsible Party)
Hoffmann-La Roche
Clinicaltrials.gov Identifier
NCT06106828
Other Study ID Numbers:
GP44729
First Submitted
October 24, 2023
First Posted
October 29, 2023
Last Update Posted
May 13, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Thyroid Eye Disease
Drug: SatralizumabDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment127 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateNovember 14, 2023
Actual Primary Completion DateJuly 23, 2025
Actual Study Completion Date1mo 2d from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Satralizumab
In 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.
Drug: Satralizumab
Satralizumab will be administered by SC injection.
Placebo
In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study.
Drug: Placebo
Placebo will be administered by SC injection

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Achieving ≥ 2 millimetres (mm) Reduction in Proptosis From Baseline (Day 1) at Week 24 in the Study Eye
    Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye.
Secondary Outcome Measures
  1. Change in Proptosis
  2. Percentage of Participants Achieving ≥ 1 Grade Reduction/Improvement in Diplopia Among Participants With Baseline Diplopia
  3. Percentage of Participants Achieving Absence of Motility-induced Pain
  4. Percentage of Participants Achieving Absence of Spontaneous Pain
  5. Percentage of Participants With a ≥ 6-Point Improvement in the Visual Functioning and Appearance Sub-scale Scores of the Graves' Ophthalmopathy Quality of Life (GO-QoL)
    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 the subscales and overall score are transformed to a scale of 0 to 100. Higher total scores indicate better QoL.
  6. Percentage of Participants Achieving Overall Response
  7. Percentage of Participants Achieving a ≥ 2 Point Reduction in Clinical Activity Score (CAS) in the Study 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.
  8. Percentage of Participants Achieving CAS Value of 0 or 1 in the Study 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.
  9. Percentage of Participants Achieving ≥ 10-point Improvement in Ocular Surface Disease Index (OSDI) Overall Scores
    The OSDI instrument is a validated dry eye questionnaire, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals ranging from 0 to 100. Higher score indicates worse disease index.
  10. Change in OSDI Ocular Symptoms and Vision-related Function Subscale Scores
    The OSDI instrument is a validated dry eye questionnaire, designed to assess cornea and ocular surface symptoms. It comprises of 12 questions with three main sections concerning ocular symptoms, visual function, and environmental factors. For each question, participants selects a number between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time" with totals ranging from 0 to 100. Higher score indicates worse disease index.
  11. Change in Oxford Corneal Staining Scores
    Oxford corneal staining chart 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 (Grade 0-I: normal; Grade II-III: mild to moderate; Grade IV-V: severe). Higher grade indicates worse disease index.
  12. Percentage of Participants Achieving ≥ 2mm Reduction in Proptosis at Week 48 in the Study eye
  13. Percentage of Participants Requiring Surgical Intervention for TED
  14. Percentage of Participants With Worsening of Proptosis by ≥ 2 mm
  15. Change in CAS
  16. Percentage of Participants With Adverse Events (AEs), With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5)
  17. Serum Concentration of Satralizumab

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
\- Clinical diagnosis of TED based on CAS
Exclusion Criteria
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

Contacts and Locations

Sponsors and CollaboratorsHoffmann-La Roche
Locations
Plastics-Orbit-Neuro | San Diego California, United States, 92108Connecticut Eye Consultants, P.C. | Danbury Connecticut, United States, 06810University of Illinois Eye and Ear Infirmary | Chicago Illinois, United States, 60612Scheie Eye Institute | Philadelphia Pennsylvania, United States, 19104Vanderbilt Eye Institute | Nashville Tennessee, United States, 37232-8808Retina Consultants of Texas | San Antonio Texas, United States, 78251University of Alberta | Edmonton Alberta, Canada, Toronto Retina Institute | Toronto Ontario, Canada, M3C 0G9Universite de Montreal - Hopital Maisonneuve-Rosemont | Montreal Quebec, Canada, H1T 2M4Peking Union Medical College Hospital | Beijing , China, 100032Peking University Third Hospital | Beijing , China, 100191Beijing Tongren Hospital, Capital Medical University | Beijing , China, 100730Xi'an Fourth Hospital | Xi'an , China, 710004CHU Nantes - Hotel Dieu | Nantes , France, 44093CHNO Hopital des Quinze Vingts | Paris , France, 75012Fondation Rothschild | Paris , France, 75019Hadassah MC | Jerusalem , Israel, 9112001Rabin MC | Petah Tikva , Israel, 4941492Sheba medical center | Ramat Gan , Israel, Specjalistyczny Osrodek Okulistyczny Oculomedica | Bydgoszcz , Poland, 85-316Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia | Gdansk , Poland, 80-180AIBILI - Association for Innovation and Biomedical Research on Light | Coimbra , Portugal, 3000-548Seoul National University Bundang Hospital | Seongnam-si , South Korea, 13620Severance Hospital, Yonsei University Health System | Seoul , South Korea, 003-722Chung-Ang University Hospital | Seoul , South Korea, 06973Samsung Medical Center | Seoul , South Korea, 135-710Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat Barcelona, Spain, 8907Hospital Universitario Vall d Hebron | Barcelona , Spain, 08035Hospital Universitario Virgen de las Nieves | Granada , Spain, 18012Hospital Ramon y Cajal | Madrid , Spain, 28031Hospital Universitario Clínico San Carlos | Madrid , Spain, 28040Hospital Universitario Virgen de la Macarena | Seville , Spain, 41007Hospital Universitario la Fe: Servicio de Oftalmologia | Valencia , Spain, 46026Sussex Eye Hospital | Brighton , United Kingdom, BN2 5BFBristol Eye Hospital | Bristol , United Kingdom, BS1 2LXGartnavel General Hospital | Glasgow , United Kingdom, G12 0YNSt James University Hospital | Leeds , United Kingdom, LS9 7TFRoyal Liverpool University Hospital | Liverpool , United Kingdom, L7 8XPMoorfields Eye Hospital NHS Foundation Trust | London , United Kingdom, EC1V 2PDMaidstone Hospital | Maidstone, Kent , United Kingdom, ME16 9QQ
Investigators
Study Director: Clinical Trials, Hoffmann-La Roche