Actively Recruiting
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Led by Sling Therapeutics, Inc. · Updated on 2025-02-25
75
Participants Needed
2
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.
CONDITIONS
Official 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 double-mask period of VGN-TED-301 and are proptosis non-responders (less than 2 mm reduction in proptosis in the study eye) at Week 24 or proptosis responders who relapse during the Follow-Up period of VGN-TED-301
- Have not received any treatment for Thyroid Eye Disease since Week 24 of VGN-TED-301
- Are euthyroid or have mild hypo- or hyperthyroidism (free thyroxine and free triiodothyronine levels less than 50% above or below normal limits) at baseline, with efforts to maintain euthyroid state during the trial
- Do not require immediate ophthalmic surgery, radiotherapy to orbits, or other ophthalmological intervention at baseline and are not planning such treatment during the study
You will not qualify if you...
- Must also meet the exclusion criteria of protocol VGN-TED-301
AI-Screening
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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
CONTACT
R
Robin Schmidt
CONTACT
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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