Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Launched by SLING THERAPEUTICS, INC. · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a medication called linsitinib on patients with moderate to severe Thyroid Eye Disease (TED). The goal is to see how well this drug works, how safe it is, and how it behaves in the body over a longer period. The study is specifically looking at patients who either did not see improvement in their eye symptoms after a previous study or who improved but then experienced a relapse afterward.

To be eligible for the trial, participants must have completed a previous study and either did not respond well to treatment or relapsed afterward. They should also not have received any TED treatment since that previous study and should have stable thyroid levels. Participants can expect regular check-ins and monitoring throughout the study to track their progress and any side effects. It's important to note that those who need immediate eye surgery or other urgent treatments are not eligible for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (\< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301
• • Subject has not received any treatment for TED since Week 24 of VGN-TED-301
• • Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine levels \[FT3\] \<50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial
• • Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study
• Exclusion Criteria:
• • The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.