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

Last updated: March 13, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

Placebo

Satralizumab

Placebo

Clinical Study ID

NCT06106828
GP44729
2023-503669-50-00
  • 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: 127
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 15, 2023
Estimated Completion Date:
May 04, 2026

Connect with a study center

  • Serac Eye and Skin Care Centre

    Calgary, Alberta
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta
    Canada

    Site Not Available

  • University of Alberta; Department of Ophthalmology and Visual Sciences

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • Toronto Retina Institute

    Toronto, Ontario M3C 0G9
    Canada

    Site Not Available

  • Universite de Montreal - Hopital Maisonneuve-Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Beijing Hospital of Ministry of Health

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, 100730
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing City, 100032
    China

    Site Not Available

  • Xi'an Fourth Hospital

    Xi'an City, 710004
    China

    Site Not Available

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu; Ophthalmology

    Nantes, 44093
    France

    Active - Recruiting

  • CHNO Hopital des Quinze Vingts

    Paris, 75012
    France

    Site Not Available

  • CHNO Hopital des Quinze Vingts; Medecine interne

    Paris, 75012
    France

    Active - Recruiting

  • CHU de La Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • CHU de La Pitie Salpetriere; Service d Ophtalmologie

    Paris, 75013
    France

    Active - Recruiting

  • Fondation Rothschild

    Paris, 75019
    France

    Site Not Available

  • Fondation Rothschild; Fondation Ophtalmologique Adolphe de Rothschild, Ophtalmologie

    Paris, 75019
    France

    Active - Recruiting

  • Hadassah MC

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Hadassah MC; Ophtalmology

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin MC

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Rabin MC; Ophtalmology

    Petach Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba medical center

    Ramat Gan,
    Israel

    Site Not Available

  • Sheba medical center; Ophtalmology

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 003-722
    Korea, Republic of

    Site Not Available

  • NZOZ Specjalistyczna Poradnia Lekarska Adrian Wojciech Przystupa

    Bielsk Podlaski, 17-100
    Poland

    Site Not Available

  • Specjalistyczny O?rodek Okulistyczny Oculomedica

    Bydgoszcz, 85-316
    Poland

    Site Not Available

  • Optimum Profesorskie Centrum Okulistyki

    Gda?sk, 80-809
    Poland

    Site Not Available

  • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

    Gliwice, 44-100
    Poland

    Site Not Available

  • Centrum Medyczne Dietla 19 Sp. Z O.O.

    Kraków, 31-070
    Poland

    Site Not Available

  • Centrum Medyczne CMP

    Piaseczno, 05-500
    Poland

    Site Not Available

  • Caminomed

    Tarnowskie Góry, 42-600
    Poland

    Site Not Available

  • AIBILI - Association for Innovation and Biomedical Research on Light

    Coimbra, 3000-548
    Portugal

    Site Not Available

  • Hospital CUF Descobertas

    Lisboa, 1998-018
    Portugal

    Site Not Available

  • Unidade Local de Saúde de Entre Douro e Vouga

    Santa Maria Da Feira, 4520-211
    Portugal

    Site Not Available

  • Unidade Local de Saúde de Gaia/Espinho

    Vila Nova de Gaia, 4434-502
    Portugal

    Site Not Available

  • Hospital Universitari de Bellvitge

    Hospitalet De Llobregat, Barcelona 8907
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia

    Hospitalet De Llobregat, Barcelona 8907
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Vall d Hebron; servicio de oftalmologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18012
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves; Servicio de Oftalmología

    Granada, 18012
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid, 28031
    Spain

    Site Not Available

  • Hospital Ramon y Cajal; Servicio de Oftalmologia

    Madrid, 28031
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena

    Sevilla, 41007
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

    Sevilla, 41007
    Spain

    Active - Recruiting

  • Hospital Universitario la Fe: Servicio de Oftalmologia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Clinico Universitario Lozano Blesa; Servicio de Oftalmologia

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Sussex Eye Hospital

    Brighton, BN2 5BF
    United Kingdom

    Site Not Available

  • Bristol Eye Hospital

    Bristol, BS1 2LX
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital; Tennent Institute of Ophthalmology

    Glasgow, G12 0YN
    United Kingdom

    Active - Recruiting

  • St James University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ
    United Kingdom

    Site Not Available

  • Maidstone Hospital; Eye Unit

    Maidstone, Kent, ME16 9QQ
    United Kingdom

    Active - Recruiting

  • Plastics-Orbit-Neuro

    San Diego, California 92108
    United States

    Site Not Available

  • Eye Care Center of Northern Colorado PC

    Longmont, Colorado 80503
    United States

    Site Not Available

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • University of Illinois Eye and Ear Infirmary

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois Eye and Ear Infirmary; Department of Ophthalmology

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Springfield Clinic, LLP

    Springfield, Illinois 62703
    United States

    Site Not Available

  • Springfield Clinic, LLP; Clinical Research Dept.

    Springfield, Illinois 62703
    United States

    Active - Recruiting

  • Vance Thompson Vision

    Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43212-3153
    United States

    Site Not Available

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Vanderbilt Eye Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Neuro-Eye Clinic Trials

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Neuro-Eye Clinic Trials

    Houston, Texas 77074
    United States

    Site Not Available

  • Robert Cizik Eye Clinic

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina Consultants of Texas

    San Antonio, Texas 78251
    United States

    Site Not Available

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