NCT06106828

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Satralizumab	Satralizumab will be administered by SC injection.
DRUG	Placebo	Placebo will be administered by SC injection

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-07-24
• Completion: 2026-06-25
• First posted: 2023-10-30
• Last updated: 2026-02-17

Locations

41 sites across 10 countries: United States, Canada, China, France, Israel, Poland, Portugal, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study