A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Participants With Thyroid Eye Disease (SatraGO-2)

Thyroid Eye Disease Clinical Trial

— SatraGO-2  

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: NCT06106828
• Other study ID #: GP44729
• Status: Recruiting
• Phase: Phase 3
• Start date: November 15, 2023
• Est. completion date: May 4, 2026

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number GP44729 www.roche.com/about_roche/roch
• Phone: 888-662-6728 (U.S. Only)
• Email: global-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: May 15, 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
Canada	University of Alberta; Department of Ophthalmology and Visual Sciences	Edmonton	Alberta
Canada	Universite de Montreal - Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Toronto Retina Institute	Toronto	Ontario
China	Beijing Hospital of Ministry of Health	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing
China	Peking University Third Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing City
China	Xi'an Fourth Hospital	Xi'an City
France	CHU Nantes - Hôtel Dieu; Ophthalmology	Nantes
France	CHNO Hopital des Quinze Vingts; Medecine interne	Paris
France	CHU de La Pitie Salpetriere; Service d Ophtalmologie	Paris
France	Fondation Rothschild; Fondation Ophtalmologique Adolphe de Rothschild, Ophtalmologie	Paris
Israel	Hadassah MC; Ophtalmology	Jerusalem
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Spain	Hospital Universitario Vall d Hebron; servicio de oftalmologia	Barcelona
Spain	Hospital Universitario Virgen de las Nieves; Servicio de Oftalmología	Granada
Spain	Hospital Ramon y Cajal; Servicio de Oftalmologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia	Madrid
Spain	Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia	Sevilla
Spain	Hospital Universitario la Fe: Servicio de Oftalmologia	Valencia
Spain	Hospital Clinico Universitario Lozano Blesa; Servicio de Oftalmologia	Zaragoza
United Kingdom	Sussex Eye Hospital	Brighton
United Kingdom	Gartnavel General Hospital; Tennent Institute of Ophthalmology	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; Eye Unit	Maidstone, Kent
United States	Neuro-Eye Clinic Trials	Bellaire	Texas
United States	Ohio State University	Columbus	Ohio
United States	Scheie Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  China,  France,  Israel,  Korea, Republic of,  Spain,  United Kingdom, 

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 from baseline to Week 24		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