Actively Recruiting
Extension Study to Evaluate Two Doses of Linsitinib in Adults With Active, Moderate to Severe Thyroid Eye Disease
Led by Sling Therapeutics, Inc. · Updated on 2025-02-25
75
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the continued effects of linsitinib in adults with active, moderate to severe Thyroid Eye Disease (TED) who participated in a previous study (VGN-TED-301). This extension study focuses on participants who either did not respond to treatment by Week 24 or who relapsed during the follow-up period. The goal is to further assess the drug's effectiveness, safety, and how the body processes and responds to it over time. Participants will receive one of two doses of linsitinib, taken twice daily by mouth. The study is randomized and double-blind, meaning neither participants nor researchers know which dose is given. The treatment period lasts 24 weeks, during which participants are monitored to evaluate changes in eye protrusion (proptosis) and other disease symptoms. This study continues from the previous trial without introducing new treatment types. Throughout the study, participants will undergo evaluations of their eye condition, including measuring proptosis and overall disease activity using standardized assessments. Quality of life related to Graves' Ophthalmopathy will also be measured through questionnaires. Safety and drug effects will be closely monitored. The study is expected to last at least 24 weeks, focusing on how participants respond to linsitinib over this period.
CONDITIONS
Brief Title
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the 24-week treatment period of the VGN-TED-301 study
- Are proptosis non-responders (less than 2 mm reduction) at Week 24 or relapsed during follow-up
- Have not received any treatment for Thyroid Eye Disease since Week 24 of VGN-TED-301
- Are euthyroid or have mild thyroid hormone abnormalities (FT4 and FT3 levels within 50% above or below normal)
- Do not require immediate eye surgery, radiotherapy, or other ophthalmological interventions and are not planning such treatments during the study
You will not qualify if you...
- Any exclusion criteria applied in the previous VGN-TED-301 study also apply to this extension study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants take linsitinib medication by mouth twice daily at either a low or high dose to treat thyroid eye disease.
Visits scheduled according to study protocol during treatment period
Trial Site Locations
Total: 2 locations
1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
2
West Virginia University Eye Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
C
Cathy Radovich
R
Robin Schmidt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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