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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease
Sponsor: Hoffmann-La Roche
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
127
Start Date
2023-11-15
Completion Date
2026-06-25
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Satralizumab
Satralizumab will be administered by SC injection.
Placebo
Placebo will be administered by SC injection
Locations (41)
Plastics-Orbit-Neuro
San Diego, California, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Retina Consultants of Texas
San Antonio, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
Toronto Retina Institute
Toronto, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Hospital of Ministry of Health
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Xi'an Fourth Hospital
Xi'an, China
CHU Nantes - Hotel Dieu
Nantes, France
CHNO Hopital des Quinze Vingts
Paris, France
Fondation Rothschild
Paris, France
Hadassah MC
Jerusalem, Israel
Rabin MC
Petah Tikva, Israel
Sheba medical center
Ramat Gan, Israel
Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, Poland
Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
Gdansk, Poland
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, Portugal
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d Hebron
Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Universitario la Fe: Servicio de Oftalmologia
Valencia, Spain
Sussex Eye Hospital
Brighton, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom
St James University Hospital
Leeds, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
Maidstone Hospital
Maidstone, Kent, United Kingdom