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ACTIVE NOT RECRUITING
NCT06106828
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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

Interventions

DRUG

Satralizumab

Satralizumab will be administered by SC injection.

DRUG

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