THRIVE-2
Research type
Research Study
Full title
A randomized, double-masked, placebo-controlled safety, tolerability, and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)
IRAS ID
1008655
Contact name
Barrett Katz
Contact email
Sponsor organisation
Viridian Therapeutics, Inc.
Eudract number
2023-507217-10
Clinicaltrials.gov Identifier
Research summary
Thyroid eye disease (TED) is an autoimmune condition most commonly related to overproduction of the thyroid hormones (hyperthyroidism). TED causes pain, redness and swelling in the tissues in and around the eyes, leading to bulging of eyes (proptosis), double vision (diplopia), reduced movement of one or both eyes (restricted duction and version), and increased pressure on the nerves in the eyes, eventually followed by loss of vision.
Treatment has historically included vitamins, corticosteroids, topical agents, and antibiotics to address various symptoms of TED. As symptoms become more severe, the only alternatives have historical been surgery and radiation therapy. Biologic therapies have been used to treat TED, but there is little supportive clinical data, and none are licensed for the treatment of TED.
Teprotumumab, a fully human monoclonal antibody (laboratory-produced protein that acts like a human antibody) which targets IGF-1R, a protein present on the surface of eye cells, was recently approved for the treatment of TED in the USA and active TED in Brazil. In clinical trials teprotumumab was more effective than placebo in reducing TED symptoms. While this therapy has been a transformational intervention for patients, it requires eight infusions over 24 weeks, administered at an infusion centre, and is often accompanied by adverse events.
This study, sponsored by Viridian Therapeutics, Inc., will test the safety, efficacy and tolerability of VRDN-001 when used for the treatment of chronic TED. Approximately 159 patients with chronic TED will be recruited to around 55 sites in Australia, Canada, EU, Israel, Turkey, UK and USA. VRDN-001 is also a humanised monoclonal antibody which targets IGF-1R. By blocking IGF-1R, it is thought that VRDN-001 will disrupt inflammation which contributes to TED, thus relieving chronic TED symptoms.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0002
Date of REC Opinion
7 Feb 2024
REC opinion
Further Information Favourable Opinion