LIDS Extension
Research type
Research Study
Full title
A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
IRAS ID
1007356
Contact name
Cathy Radovich
Contact email
Sponsor organisation
Sling Therapeutics, Inc.
Eudract number
2022-003687-24
Research summary
Sling Therapeutics is investigating a new medication (also known as the “study drug”) called linsitinib as a possible treatment for active, moderate to severe thyroid eye disease (TED). Linsitinib is a small molecule that blocks a protein that is thought to play an important role in the development of TED and stops the secretion of an acid that is produced as a result of TED.
The main goal of this research study is to continue to learn how well linsitinib works to treat TED; how the body processes linsitinib; about linsitinib’s effects; and how safe linsitinib is in people who completed the treatment period of the previous study (VGN-TED-301). In VGN-TED-301 some participants received placebo (inactive drug) instead of the active drug and therefore may have had no response.
This is an extension study to VGN-TED-301 at the same UK research sites and gives all participants who did not respond to the study drug in the previous study the opportunity to receive the active study drug should they decide to participate.
Participation in this extension study is voluntary and if participants decide not to participate in this study they may continue in the original study (VGN-TED-301), or to exit that study and receive standard-of-care (regular) treatment.
If participants’ thyroid eye disease showed little to no improvement at the Week 24 assessment in the previous study, and they choose to participate, they will be in this study for approximately 96 weeks (about 22 months). They will need to come to the study centre a minimum of 12 times and have 2 telephone visits during this period.
If participants’ thyroid eye disease improved at the 24 Week assessment in the previous study but worsened during the follow-up period, and they choose to participate, they will be in this study for approximately 72 weeks (about 17 months). They will need to come to the study centre a minimum of 9 times and have 2 telephone visits during this period.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0118
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion