Evaluating linsitinib for thyroid eye disease
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)
PHASE2; PHASE3 · Sling Therapeutics, Inc. · NCT06112340
This study is testing if a new drug called linsitinib can help people with moderate to severe thyroid eye disease who haven't improved with other treatments.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sling Therapeutics, Inc. (industry) |
| Drugs / interventions | linsitinib |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06112340 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in patients with active, moderate to severe thyroid eye disease who did not respond to previous treatment or experienced a relapse. Participants must have completed a prior study and meet specific criteria regarding their thyroid condition. The study will involve administering two doses of linsitinib to eligible subjects and monitoring their responses over time.
Who should consider this trial
Good fit: Ideal candidates are individuals who completed a previous study and are either non-responders or relapsed patients with controlled thyroid conditions.
Not a fit: Patients who require immediate ophthalmic surgery or have uncontrolled thyroid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved outcomes for patients suffering from thyroid eye disease.
How similar studies have performed: Previous studies have shown varying success with treatments for thyroid eye disease, but this specific approach with linsitinib is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 1 other locations
- Bascom Palmer Eye Institute — Miami, Florida, United States (RECRUITING)
- West Virginia University Eye Institute — Morgantown, West Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Cathy Radovich
- Email: info@slingtx.com
- Phone: 734-887-9192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases, Thyroid Associated Ophthalmopathy, Graves Ophthalmopathy, Thyroid Diseases, Orbital Diseases