A study of efgartigimod PH20 SC given by prefilled syringe in adults with thyroid eye disease
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease
IRAS ID
1010354
Contact name
Sabine Coppieters
Contact email
Sponsor organisation
Argenx
Clinicaltrials.gov Identifier
Research summary
This study aims to look at the safety and effect (efficacy, or how well it works) of the study drug (Efgartigimod) in people with thyroid eye disease (TED). The study will research how the study drug is absorbed and removed from the body. It will also explore how the immune system reacts to the study drug. Efgartigimod is a piece of a human antibody modified to bind better to a specific protein called FcRn. Antibodies are proteins that fight and prevent infections. FcRn helps maintain antibody levels.
Efgartigimod is similar to antibodies naturally present in the human body. It is called a “biological” drug because it is a piece of protein produced in the cells of mammals. Efgartigimod may help improve TED. This is because efgartigimod may reduce the antibodies that cause symptoms in patients with TED. Efgartigimod has been approved as a treatment for adult patients with myasthenia gravis, a rare disease causing muscle weakness. Efgartigimod is also being studied as a treatment for other autoimmune conditions (conditions in which your immune system attacks part of your body). It is considered investigational because health authorities have not approved it for the treatment of TED. The study will last about 1 to 2 years depending on how participants individually respond to the study drug.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0100
Date of REC Opinion
8 Oct 2024
REC opinion
Further Information Favourable Opinion