Interleukin-6 receptor (IL-6R) signaling inhibition with satralizumab in thyroid eye disease (TED): phase 3 SatraGO-1 and SatraGO-2 trial design
Accept poster if oral is not possible ?
Yes
Purpose
TED is an inflammatory orbitopathy that can cause facial disfigurement and vision loss. Disease-modifying treatments are needed as current therapies for active TED may be ineffective, cause relapses, or lead to side-effects, while inactive TED is largely treated surgically. Interleukin-6 (IL-6) and its receptor (IL-6R) are implicated in TED pathogenesis. Satralizumab, a humanized monoclonal anti–IL-6R antibody with recycling technology, enhances IL-6 suppression to address inflammation, with subcutaneous (SC) dosing every 4 weeks (Q4W). We describe the SatraGO-1 and SatraGO-2 trials evaluating satralizumab in TED.
Methods
SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828) are identical, global, phase 3, randomized, double-masked, placebo-controlled, 72-week trials to recruit ~120 participants (pts) across ~70 sites in 20 countries. Pts ≥18 years with moderate-to-severe active or stable inactive TED are eligible if the systemic disease is controlled (euthyroid or mild hyper-/hypothyroidism). Pts will be randomized 1:1 to SC satralizumab or placebo at weeks (W) 0, 2, and 4 (loading doses), then Q4W through W20. From W24, nonresponders continue satralizumab Q4W; proptosis responders re-randomized to satralizumab or placebo Q4W through W44.
Results
Primary endpoint: proportion of active TED pts achieving a proptosis response (≥2 mm proptosis improvement from baseline) at W24. Safety outcomes include incidence, seriousness, and severity of adverse events.
Conclusion
SatraGO-1 and SatraGO-2 are investigating IL-6R inhibition via satralizumab as a potential disease-modifying treatment in TED with reduced safety risks vs current options.
Conflict of interest
No
1
Last name
CORONEL
Initials of first name(s)
M
Department
Charles Research Center Paraguay 1896, Piso 2 C1121ABB
City
Buenos Aires
Country
Argentina
2
Last name
Ezra
Initials of first name(s)
D
Department
Ophthalmology, Oculoplastic Surgery, Moorfields Eye Hospital and University College London
City
London
Country
United Kingdom
3
Last name
Collins
Initials of first name(s)
A
Department
Ophthalmology, Oculoplastic Surgery, Kaiser Permanente
City
Fresno, CA
Country
United States
4
Last name
Stan
Initials of first name(s)
M
Department
Endocrinology, Chair Thyroid Core Group, Mayo Clinic
City
Rochester, MN
Country
United States
5
Last name
Haskova
Initials of first name(s)
Z
Department
Genentech, Inc.
City
South San Francisco, CA
Country
United States
6
Last name
Kuenzel
Initials of first name(s)
T
Department
F. Hoffmann-La Roche Ltd.
City
Basel
Country
Switzerland
7
Last name
Triyatni
Initials of first name(s)
M
Department
F. Hoffmann-La Roche Ltd.
City
Basel
Country
Switzerland
8
Last name
Idowu
Initials of first name(s)
O
Department
Genentech, Inc.
City
South San Francisco, CA
Country
United States
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