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NCT05987423 · ClinicalTrials.gov record · last posted 2026-07-31

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

Study acronym: SatraGO-1
StatusCompleted
PhasePhase 3
Started2023-10-26
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from the ClinicalTrials.gov record
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).

Protocol amendment history 2 changes detected by DataLookout

2026-08-01
Trial completed
2026-08-01
Primary endpoint(s) modified
WasPercentage of Participants Achieving ≥ 2mm Reduction in Proptosis from Baseline (Day 1) at Week 24 in the Study eye
NowPercentage of Participants in the Active TED Population Who Achieved ≥ 2 Millimeters (mm) Reduction in Proptosis From Baseline at Week 24 in the Study Eye
Trial Details
NCT Number NCT05987423
Lead Sponsor Hoffmann-La Roche
Conditions Thyroid Eye Disease, TED
Enrollment 131 participants
Start Date 2023-10-26
Primary Completion 2025-07-08 (estimated)
Study Completion 2026-06-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-31