Overview
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Status:
Recruiting
Recruiting
Trial end date:
2026-06-01
2026-06-01
Target enrollment:
0
0
Participant gender:
All
All
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. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sling Therapeutics, Inc.
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.