Status:
RECRUITING
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Lead Sponsor:
Sling Therapeutics, Inc.
Conditions:
Thyroid Eye Disease
Graves Orbitopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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. ...
Eligibility Criteria
Inclusion
- 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
- The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06112340
Start Date
October 11 2023
End Date
June 1 2026
Last Update
February 25 2025
Active Locations (2)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
2
West Virginia University Eye Institute
Morgantown, West Virginia, United States, 26506