A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Sling Therapeutics, Inc.
Summary
The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must be ≥ 18 years of age at Screening 2. Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline. 3. Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tis…
Interventions
- Druglinsitinib
150 mg linsitinib is taken twice daily by mouth for 24 weeks
- DrugPlacebo
0 mg placebo taken twice daily by mouth for 24 weeks
Location
- Advancing Research InternationalLas Vegas, Nevada