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

NCT05987423 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GP444672023-503309-13-00
• Study Type: interventional
• Target: 131
• Locations: 9 countries
• Sites: 45

Brief 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).

Conditions

Thyroid Eye Disease; TED

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye

  Percentage of participants in the active TED population (i.e., participants who have active disease) who achieved a ≥ 2 mm reduction in proptosis from baseline (Day 1) to Week 24 in the study eye, with no corresponding deterioration of proptosis (≥ 2 mm increase) in the fellow eye has been reported. Percentages have been rounded off.

  At Week 24

Secondary Outcomes (37)

• Percentage of Participants in the Overall Population Who Achieved ≥ 2 mm Reduction in Proptosis From Baseline at Week 24 in the Study Eye

  At Week 24

• Change From Baseline in Proptosis at Week 24 in Active TED Population for Study Eye

  At Week 24

• Change From Baseline in Proptosis at Week 24 in Overall Population for Study Eye

  At Week 24

• Percentage of Participants in Active TED Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24

  At Week 24

• Percentage of Participants in the Overall Population Achieving ≥ 1 Grade Reduction/Improvement in Diplopia at Week 24

  At Week 24

Study Arms (2)

Satralizumab

EXPERIMENTAL

In the Part I period, participants will receive satralizumab every 4 weeks (q4w) followed by proptosis response-based individualized treatment in Part II of the study

Drug: Satralizumab

Placebo

PLACEBO COMPARATOR

In the part I period, participants will receive placebo q4w followed by proptosis response-based individualized treatment in part II of the study

Drug: Placebo

Interventions

Satralizumab DRUG

Satralizumab will be administered by SC injection.

Satralizumab

Placebo DRUG

Placebo will be administered by SC injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of TED based on CAS

You may not qualify if:

• Decrease in CAS or proptosis of \>= 2 points or \>= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
• Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
• Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (46)

Thrive Health Research LLC

Beverly Hills, California, 90210, United States

Location

UCSD Shiley Eye Center

La Jolla, California, 92093-0946, United States

Location

Grene Vision Group, LLC

Wichita, Kansas, 67206, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Great Lakes Eye Care

Saint Joseph, Michigan, 49085, United States

Location

'Northwell Health Physician Partners Ophthalmology

Great Neck, New York, 11021, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Austin Retina Associates

Austin, Texas, 78705-1169, United States

Location

Eyelid Center of Utah

Salt Lake City, Utah, 84102, United States

Location

WVU Eye Institute

Morgantown, West Virginia, 26506, United States

Location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425, Argentina

Location

Centro Oftalmologico Dr. Charles S.A.

Capital Federal, C1015ABO, Argentina

Location

Oftalmos

Capital Federal, C1120AAN, Argentina

Location

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

Location

Centrovision Mendoza

Mendoza, M5500BWG, Argentina

Location

Grupo Laser Vision

Rosario, S2000DLA, Argentina

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

Dresden, 01307, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinikum Munster

Münster, 48149, Germany

Location

Universitäts-Augenklinik Tübingen

Tübingen, 72076, Germany

Location

Hong Kong Eye Hospital

Mong Kok, Hong Kong

Location

Budapest Retina Associates Kft.

Budapest, 1133, Hungary

Location

A.O. U. Federico II

Naples, Campania, 80131, Italy

Location

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Location

Ospedale Di Circolo E Fondazione Macchi

Varese, Lombardy, 21100, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56124, Italy

Location

Aichi Medical University Hospital

Aichi, 480-1195, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Social Medical Corporation Tenjinkai Shinkoga Hospital

Fukuoka, 830-8577, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Kobe Kaisei Hospital Medical foundation

Hyōgo, 657-0068, Japan

Location

Hospital of the University of Occupational and Environmental Health,Japan

Kitakyushu-shi, 807-8556, Japan

Location

National Hospital Organization Kyoto Medical Center

Kyoto, 612-8555, Japan

Location

University of Miyazaki Hospital

Miyazaki, 889-1692, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Olympia Eye Hospital

Tokyo, 150-0001, Japan

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Related Publications (1)

• Ezra D, Collins A, Haskova Z, Kuenzel T, Ida H, Triyatni M, Brittain C, Idowu O. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025 Dec;14(12):3119-3132. doi: 10.1007/s40123-025-01255-3. Epub 2025 Oct 9.

  PMID: 41066062 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

satralizumab

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 14, 2023
• Study Start: October 26, 2023
• Primary Completion: July 8, 2025
• Study Completion: June 25, 2026
• Last Updated: July 31, 2026
• Results First Posted: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

HK (1); JP (10); US (11); IT (5); AR (6); DE (6); SG (2); HU (1); AU (3)