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

Last updated: May 16, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

Placebo

Satralizumab

Placebo

Clinical Study ID

NCT05987423
GP44467
2023-503309-13-00
2023-503309-13
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of TED based on CAS

Exclusion

Exclusion Criteria:

  • Decrease in CAS or proptosis of >= 2 points or >= 2 mm, respectively, in the studyeye between Screening and Study Baseline (Day 1)

  • Requiring immediate surgical ophthalmological intervention or planning correctivesurgery or irradiation during the course of the study, in the judgment of theinvestigator

  • Identified pre-existing ophthalmic disease that, in the judgment of theinvestigator, would preclude study participation or complicate interpretation ofstudy results, including corneal decompensation unresponsive to medical managementand including ophthalmic diseases that will likely require prohibited therapy duringthe study

  • Any serious medical condition or abnormality in clinical laboratory tests that, inthe investigator's judgment, precludes an individual's safe participation in andcompletion of the study

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study orwithin 3 months after the final dose of satralizumab

Study Design

Total Participants: 131
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 26, 2023
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Centro Oftalmológico Dr. Charles S.A.

    Capital Federal, C1015ABO
    Argentina

    Site Not Available

  • Oftalmos

    Capital Federal, C1120AAN
    Argentina

    Site Not Available

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autónoma de Buenos Aires, C1425
    Argentina

    Site Not Available

  • Centrovision Mendoza

    Mendoza, M5500BWG
    Argentina

    Site Not Available

  • Grupo Laser Vision

    Rosario, S2000DLA
    Argentina

    Site Not Available

  • Sydney Eye Hospital

    Sydney, New South Wales 2000
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Adelaide Hospital; Opthamology Department

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Centre For Eye Research Australia

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • LKH-Univ.Klinikum Graz

    Graz, 8036
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • Faculty Hospital Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • General Teaching Hospital Prague

    Prague, 128 08
    Czechia

    Site Not Available

  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Universitätsklinikum Essen; Augenklinik

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH; Klinik für Augenheilkunde

    Marburg, 35043
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster; Augenheilkunde

    Münster, 48149
    Germany

    Active - Recruiting

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Hong Kong Eye Hospital

    Mongkok,
    Hong Kong

    Site Not Available

  • Hong Kong Eye Hospital; CUHK Eye Centre

    Mongkok,
    Hong Kong

    Active - Recruiting

  • Budapest Retina Associates Kft.

    Budapest, 1133
    Hungary

    Site Not Available

  • A.O. U. Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • A.O. U. Federico II; Dipartimento di Sanità Pubblica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A Gemelli; Dipartimento di Endocrinologia

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Endocrinologia

    Milano, Lombardia
    Italy

    Active - Recruiting

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Lombardia 21100
    Italy

    Site Not Available

  • Ospedale Di Circolo E Fondazione Macchi; S.C. Endocrinologia

    Varese, Lombardia 21100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Toscana 56124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana; U.O. Endocrinologia 1

    Pisa, Toscana 56124
    Italy

    Active - Recruiting

  • Aichi Medical University Hospital

    Aichi, 480-1195
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Social Medical Corporation Tenjinkai Shinkoga Hospital

    Fukuoka, 830-8577
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • Kobe Kaisei Hospital Medical foundation

    Hyogo, 657-0068
    Japan

    Site Not Available

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

    Kitakyushu-shi, 807-8556
    Japan

    Site Not Available

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555
    Japan

    Site Not Available

  • University of Miyazaki Hospital

    Miyazaki, 889-1692
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Olympia Eye Hospital

    Tokyo, 150-0001
    Japan

    Site Not Available

  • Eagle Eye Centre - Mount Alvernia Hospital

    Singapore, 574623
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • National University Hospital; Ophthalmology Department

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Singapore Eye Research Institute

    Singapore, 168751
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital; Ophthalmology Department

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Thrive Health Research LLC

    Beverly Hills, California 90210
    United States

    Site Not Available

  • UCSD Shiley Eye Center

    La Jolla, California 92093-0946
    United States

    Site Not Available

  • Thrive Health Research LLC

    Los Angeles, California 90210
    United States

    Site Not Available

  • USC Roski Eye Institute

    Los Angeles, California 90333
    United States

    Site Not Available

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Grene Vision Group, LLC

    Wichita, Kansas 67206
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Great Lakes Eye Care

    S. Haven, Michigan 49090
    United States

    Site Not Available

  • Great Lakes Eye Care

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • Eye Associates of New Mexico

    Tucumcari, New Mexico 88401
    United States

    Site Not Available

  • 'Northwell Health Physician Partners Ophthalmology

    Great Neck, New York 11021
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Charleston Neuroscience Inst

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Austin Retina Associates

    Austin, Texas 78705-1169
    United States

    Site Not Available

  • Eyelid Center of Utah

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Virginia Eye Institute

    Richmond, Virginia 23230
    United States

    Site Not Available

  • WVU Eye Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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