Trials / Recruiting
RecruitingNCT06112340
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Sling Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Thyroid Eye Disease
- Graves Orbitopathy
- Endocrine System Diseases
- Eye Diseases
- Thyroid Associated Ophthalmopathy
- Graves Ophthalmopathy
- Thyroid Diseases
- Orbital Diseases
- Proptosis
- IGF1R
- Exophthalmos
- Hashimoto
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | linsitinib | Study medication taken twice daily by mouth |
Timeline
- Start date
- 2023-10-11
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2023-11-01
- Last updated
- 2025-02-25
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06112340. Inclusion in this directory is not an endorsement.