A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987423
• Other study ID #: GP44467
• Secondary ID: 2023-503309-13
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2023
• Est. completion date: May 4, 2026

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number GP44467 www.roche.com/about_roche/roch
• Phone: 888-662-6728 (U.S. Only)
• Email: lobal-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 4, 2026
• Est. primary completion date: March 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of thyroid eye disease (TED) based on CAS

Exclusion Criteria:

• 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 12 weeks after the final dose of satralizumab

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• Satralizumab
Satralizumab will be administered by SC injection.

Other:
• Placebo
Placebo will be administered by SC injection

Locations

Country	Name	City	State
Argentina	Centro Oftalmológico Dr. Charles S.A.	Capital Federal
Argentina	Oftalmos	Capital Federal
Argentina	Buenos Aires Mácula	Ciudad Autonoma Buenos Aires
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autónoma de Buenos Aires
Argentina	Centrovision Mendoza	Mendoza
Argentina	Grupo Laser Vision	Rosario
Australia	Royal Adelaide Hospital; Opthamology Department	Adelaide	South Australia
Australia	Centre For Eye Research Australia	East Melbourne	Victoria
Australia	Sydney Eye Hospital	Sydney	New South Wales
Germany	Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology	Berlin
Germany	Universitätsklinikum Freiburg, Klinik für Augenheilkunde	Freiburg
Germany	Universitätsklinikum Gießen und Marburg GmbH; Klinik für Augenheilkunde	Marburg
Germany	Universitätsklinikum Münster; Augenheilkunde	Münster
Germany	Universitäts-Augenklinik Tübingen	Tübingen
Hong Kong	Hong Kong Eye Hospital; CUHK Eye Centre	Mongkok
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; Endocrinologia	Milano	Lombardia
Italy	A.O. U. Federico II; Dipartimento di Sanità Pubblica	Napoli	Campania
Italy	Azienda Ospedaliero Universitaria Pisana; U.O. Endocrinologia 1	Pisa	Toscana
Italy	Fondazione Policlinico Universitario A Gemelli; Dipartimento di Endocrinologia	Roma	Lazio
Italy	Ospedale Di Circolo E Fondazione Macchi; S.C. Endocrinologia	Varese	Lombardia
Japan	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	Hyogo
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
Singapore	Singapore Eye Research Institute	Singapore
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Thrive Health Research LLC	Beverly Hills	California
United States	WVU Eye Institute	Morgantown	West Virginia
United States	EyeHealth Northwest	Portland	Oregon
United States	Eyelid Center of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Germany,  Hong Kong,  Italy,  Japan,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving = 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye	Provided there is no deterioration of proptosis (= 2mm increase) in the fellow eye	Baseline, Week 24
Secondary	Change in proptosis		Baseline, Week 24
Secondary	Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia		Baseline, Week 24
Secondary	Percentage of participants with adverse events (AEs), with severity determined according to National cancer institute common terminology criteria for adverse events version 5 (NCI CTCAE V5)		Baseline, Week 24