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

April 10, 2024 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta; Department of Ophthalmology and Visual Sciences
    • Ontario
      • Toronto, Ontario, Canada, M3C 0G9
        • Recruiting
        • Toronto Retina Institute
  • China
      • Beijing, China, 100191
        • Active, not recruiting
        • Peking University Third Hospital
      • Beijing, China, 100730
        • Active, not recruiting
        • Beijing Hospital of Ministry of Health
      • Beijing, China, 100730
        • Active, not recruiting
        • Beijing Tongren Hospital, Capital Medical University
      • Beijing City, China, 100032
        • Active, not recruiting
        • Peking Union Medical College Hospital
      • Xi'an City, China, 710004
        • Recruiting
        • Xi'an Fourth Hospital
  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU Nantes - Hôtel Dieu; Ophthalmology
      • Paris, France, 75012
        • Recruiting
        • CHNO Hopital des Quinze Vingts; Medecine interne
      • Paris, France, 75019
        • Recruiting
        • Fondation Rothschild; Fondation Ophtalmologique Adolphe de Rothschild, Ophtalmologie
      • Paris, France, 75013
        • Recruiting
        • CHU de La Pitie Salpetriere; Service d Ophtalmologie
  • Korea, Republic of
      • Seongnam-si, Korea, Republic of, 463-707
        • Recruiting
        • Seoul national university bundang hospital
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d Hebron; servicio de oftalmologia
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario Virgen de las Nieves; Servicio de Oftalmología
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Ramon y Cajal; Servicio de Oftalmologia
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
      • Sevilla, Spain, 41007
        • Recruiting
        • Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa; Servicio de Oftalmologia
  • United Kingdom
      • Brighton, United Kingdom, BN2 5BF
        • Recruiting
        • Sussex Eye Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool University Hospital
      • London, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital NHS Foundation Trust
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone Hospital; Eye Unit
  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212-3153
        • Recruiting
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Scheie Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Satralizumab
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
Satralizumab will be administered by SC injection.
Placebo Comparator: Placebo
In the part I period, participants will receive placebo every 4 weeks (q4w) followed by proptosis response-based individualized treatment in part II of the study
Other: Placebo
Placebo will be administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving ≥ 2mm reduction in proptosis from baseline (Day 1) at Week 24 in the study eye
Time Frame: Baseline, Week 24
Provided there is no deterioration of proptosis (≥ 2mm increase) in the fellow eye
Baseline, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in proptosis from baseline to Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percentage of participants achieving >= 1 grade reduction/improvement in diplopia among participants with baseline diplopia
Time Frame: Baseline, Week 24
Baseline, Week 24
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)
Time Frame: Baseline, Week 24
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 4, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GP44729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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