GP44729 - Satralizumab in Thyroid Eye Disease

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1007992

• Contact name

  Ethan Montenegro

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Research summary

  Thyroid Eye Disease (TED) is a chronic inflammatory disorder. The signs and symptoms of TED are highly variable in severity, ranging from mild disease which may be self-limiting, to severe sight-threatening disease in 3%–7% of cases.
  There remains an unmet medical need in patients with active moderate-to severe TED for whom IV pulses of corticosteroids (CS) and/or teprotumumab (Unites States only) are the mainstay of treatment but are not universally successful or available and are associated with disease relapses and substantial side effects. There also remains an unmet medical need in patients with chronic inactive TED for whom there is no established medical treatment and surgical intervention remains the only option for treatment.
  Evidence from a number of experiments support an important role of IL-6 and its receptor in the disease, suggesting the potential of satralizumab as a novel drug for treatment of TED.
  Satralizumab is a subcutaneously administered recycling humanised anti-IL-6R monoclonal antibody that shows pharmacological effects of IL-6R blockade at an every 4-week dosing frequency by SC injection, supported by its prolonged half-life compared with a typical IgG antibody, due to its recycling property. The drug achieves its effects by binding to the IL-6R, thereby, inhibiting IL-6 signalling and the actions of IL-6.
  The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous satralizumab, a recombinant, humanised anti‑interleukin-6 (IL-6) receptor monoclonal antibody, in participants with moderate-to-severe thyroid eye disease.
  The study will recruit 120 participants globally with approximately 21 from the UK across 6 UK sites. Each participant will be in the study for approximately 72 weeks.
  The study is sponsored by F. Hoffmann- La Roche
  Research Summary; Version 1 dated 24-JUL-2023

• REC name

  Wales REC 5

• REC reference

  23/WA/0237

• Date of REC Opinion

  11 Oct 2023

• REC opinion

  Further Information Favourable Opinion