Trials / Active Not Recruiting
Active Not RecruitingNCT05276063
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Sling Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).
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 |
| DRUG | Placebo | Placebo taken twice daily by mouth |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2024-10-15
- Completion
- 2026-09-01
- First posted
- 2022-03-11
- Last updated
- 2025-01-29
Locations
30 sites across 5 countries: United States, Canada, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05276063. Inclusion in this directory is not an endorsement.