Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease
Research type
Research Study
Full title
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
IRAS ID
1006527
Contact name
Sarah York
Contact email
Sponsor organisation
Immunovant Sciences, GmbH
Eudract number
2022-002787-68
Clinicaltrials.gov Identifier
Research summary
Thyroid Eye Disease (TED) is a rare autoimmune disorder in which the eye muscles, eyelids, tear glands and fatty tissues behind the eye become inflamed. This can cause the eyes and eyelids to become red and swollen, and the eyes can be pushed forward. For most, the same autoimmune condition that causes TED also results in Graves’ disease (GD). The current treatment options available for active, moderate or severe disease can give short-term relief. However, there is unmet need for treatments with an optimal safety profile and long-term benefits.
GD is typically characterised by the presence of autoantibodies (antibodies that mistakenly target and react with a person’s own tissues/organs), resulting in thyroid overactivity (hyperthyroidism). Studies also indicate that a type of antibody called IgG, which activates a receptor called IGF-1R in patients with GD, may contribute to TED.
The study drug, Batoclimab works by binding to a receptor that IgG antibodies usually bind to, causing the levels of IgG to be reduced in the body. The aim of treatment with Batoclimab is to decrease disease-causing antibody levels quickly and reliably, then to maintain low levels, which should reduce the symptoms of TED and prevent progression to more serious complications that could require surgical intervention.
In this study, Batoclimab is being assessed with a placebo (substance that looks the same but with no active drug) to determine its safety and benefits. 67% (2/3) of participants will receive Batoclimab, and 33% (1/3) will receive the placebo. 2 Batoclimab or placebo subcutaneous injections will be given once a week for 12 weeks, then 1 injection weekly for another 12 weeks. Participants will be in the study for approximately 32 weeks.
During the study participants will undergo assessments which include physical and eye examinations, blood and urine analysis, and ECG. At the end of this study, participants may have the opportunity to enter an open-label extension study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0014
Date of REC Opinion
20 Mar 2023
REC opinion
Further Information Favourable Opinion