LIDS LINSITINIB IGF DRUG STUDY
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
IRAS ID
1004828
Contact name
Cathy Radovich
Contact email
Sponsor organisation
VasaraGen, Inc.
Eudract number
2021-005000-36
Clinicaltrials.gov Identifier
Research summary
VasaraGen, Inc. has begun a research study of an investigational drug (also known as the “study drug”) called linsitinib as a possible treatment for active, moderate to severe thyroid eye disease. The main goal of this research study is to learn how well the study drug works to treat active, moderate to severe thyroid eye disease, how the body processes the study drug and how safe the study drug is compared with placebo. A placebo is an inactive material that looks like the study drug but does not have any active study drug. Researchers use a placebo to see if the study drug works better or is as safe as/safer than taking nothing.\nParticipants will be in this research study for about 120 weeks (about 28 months), and need to come to the study centre at least 15 times and have 2 telephone visits during this period.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
22/SC/0115
Date of REC Opinion
17 May 2022
REC opinion
Further Information Favourable Opinion