Interleukin-6 (IL-6) Receptor Signalling Inhibition With Satralizumab in Thyroid Eye Disease (TED): Phase 3 SatraGO-1 and SatraGO-2 Trial Design
Author: Daniel Ezra
Base Hospital / Institution: Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK
Rapid fire oral presentation
Abstract ID: 24-311
Purpose
TED is a complex inflammatory disease that can lead to face-altering and sight-threatening complications. An unmet need exists for disease-modifying treatment options in active TED, for which current options are associated with relapses and substantial side effects, and for inactive TED, which is largely managed with surgery. IL-6 and its receptor (IL-6R) may play a key role in TED pathogenesis. Satralizumab, a humanised monoclonal anti–IL-6R antibody, uses novel antibody recycling technology for longer duration of circulation and subcutaneous (SC) dosing every 4 weeks (Q4W). Here, we describe the design of the SatraGO-1 and SatraGO-2 trials evaluating satralizumab in TED.
Methods
SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828) are identical, global, phase 3, randomised, double-masked, placebo-controlled, 72-week multicentre studies that will recruit ~120 participants (pts) at ~40 study sites across 15 countries. Pts ≥18 years with moderate-to-severe active TED or stable, chronic inactive TED are eligible provided the systemic disease is under control (euthyroid or mild hyper/hypothyroidism). Pts will be randomised 1:1 to SC satralizumab or placebo at weeks (W) 0, 2 and 4 (loading doses) and then Q4W through W20 (maintenance doses). Based on the W24 proptosis response, nonresponders will receive satralizumab Q4W and responders will be re-randomised 1:1 to satralizumab or placebo Q4W through W44.
Results
Primary endpoint: proportion of active TED pts who achieve a proptosis response (≥2 mm proptosis improvement from baseline in study eye) at W24. Secondary endpoints include proptosis response in active and chronic TED pts and overall response (≥2-point improvement in clinical activity score from baseline and a proptosis response in study eye) in active TED pts. Safety outcomes include incidence, seriousness and severity of adverse events.
Conclusion
The SatraGO-1 and SatraGO-2 trials are investigating IL-6R inhibition via satralizumab in TED. Satralizumab offers a potential disease-modifying treatment option for TED while minimising safety risks associated with current treatments.
Additional Authors
| First name | Last name | Base Hospital / Institution |
|---|---|---|
| Atif | Collins | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Marius | Stan | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Zdenka | Haskova | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Thomas | Kuenzel | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Galin | Spicer | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Miriam | Triyatni | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
| Oluwatobi | Idowu | Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London, UK |
