Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05987423
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

131

Start Date

2023-10-26

Completion Date

2026-07-01

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

Satralizumab

Satralizumab will be administered by SC injection.

DRUG

Placebo

Placebo will be administered by SC injection

Locations (46)

Thrive Health Research LLC

Beverly Hills, California, United States

UCSD Shiley Eye Center

La Jolla, California, United States

Grene Vision Group, LLC

Wichita, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, United States

Great Lakes Eye Care

Saint Joseph, Michigan, United States

'Northwell Health Physician Partners Ophthalmology

Great Neck, New York, United States

EyeHealth Northwest

Portland, Oregon, United States

Austin Retina Associates

Austin, Texas, United States

Eyelid Center of Utah

Salt Lake City, Utah, United States

WVU Eye Institute

Morgantown, West Virginia, United States

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, Argentina

Oftalmos

Capital Federal, Argentina

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, Argentina

Centrovision Mendoza

Mendoza, Argentina

Grupo Laser Vision

Rosario, Argentina

Sydney Eye Hospital

Sydney, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Centre For Eye Research Australia

East Melbourne, Victoria, Australia

Medizinische Universitat Wien

Vienna, Austria

Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, Germany

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

Dresden, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, Germany

Universitatsklinikum Munster

Münster, Germany

Universitäts-Augenklinik Tübingen

Tübingen, Germany

Hong Kong Eye Hospital

Mong Kok, Hong Kong

Budapest Retina Associates Kft.

Budapest, Hungary

A.O. U. Federico II

Naples, Campania, Italy

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Ospedale Di Circolo E Fondazione Macchi

Varese, Lombardy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Aichi Medical University Hospital

Aichi, Japan

Kyushu University Hospital

Fukuoka, Japan

Social Medical Corporation Tenjinkai Shinkoga Hospital

Fukuoka, Japan

Hokkaido University Hospital

Hokkaido, Japan

Kobe Kaisei Hospital Medical foundation

Hyōgo, Japan

Hospital of the University of Occupational and Environmental Health,Japan

Kitakyushu-shi, Japan

National Hospital Organization Kyoto Medical Center

Kyoto, Japan

University of Miyazaki Hospital

Miyazaki, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Olympia Eye Hospital

Tokyo, Japan

National University Hospital

Singapore, Singapore

Singapore Eye Research Institute

Singapore, Singapore