Linsitinib for Thyroid Eye Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Sling Therapeutics, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing linsitinib, a medication, on patients who did not improve or got worse after previous treatment. The goal is to see if linsitinib can help these patients by blocking certain proteins that make their condition worse.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you must not have received any treatment for Thyroid Eye Disease since Week 24 of the previous study.
What data supports the effectiveness of the drug Linsitinib for treating Thyroid Eye Disease?
Research shows that Linsitinib, which targets specific proteins involved in Thyroid Eye Disease, can reduce disease development and progression. Similar drugs like Teprotumumab, which also target the same proteins, have been effective in treating this condition.
12345How is the drug Linsitinib different from other treatments for thyroid eye disease?
Linsitinib is unique because it targets both the insulin-like growth factor 1 receptor (IGF-1R) and the insulin receptor (IR), potentially offering a novel approach to treating thyroid eye disease, which currently has limited treatment options.
15678Eligibility Criteria
This trial is for individuals with active, moderate to severe Thyroid Eye Disease (TED) who participated in a previous study (VGN-TED-301) but didn't respond well or relapsed. They shouldn't have received any TED treatments since that study and must have their thyroid disease under control or only mildly off from normal levels.Inclusion Criteria
I completed 24 weeks of VGN-TED-301 without significant eye bulging reduction or my condition worsened after initial improvement.
I haven't had treatment for TED since Week 24 of VGN-TED-301.
Participant Groups
The trial continues to test the effects of Linsitinib on patients with TED. It focuses on those who either did not respond adequately to previous treatment by Week 24 of the initial VGN-TED-301 study or had a relapse during its follow-up period.
2Treatment groups
Active Control
Group I: High DoseActive Control1 Intervention
Active Arm High Dose Linsitinib
Group II: Low DoseActive Control1 Intervention
Active Arm Low Dose Linsitinib
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
West Virginia University Eye InstituteMorgantown, WV
Bascom Palmer Eye InstituteMiami, FL
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Who is running the clinical trial?
Sling Therapeutics, Inc.Lead Sponsor
References
Efficacy of teprotumumab therapy in patients with long-duration thyroid eye disease. [2023]Teprotumumab, an inhibitor of the insulin-like growth factor 1 receptor (IGF-1R), was approved by the US Food and Drug Administration in January 2020 for the treatment of thyroid eye disease (TED). The clinical trials leading to its approval enrolled patients with recent disease onset and significant inflammatory symptoms and signs. Subsequent real-world teprotumumab use in patients with longer duration of disease also may be effective, and there have been several publications reporting on experience in these patient groups.
Teprotumumab for the treatment of chronic thyroid eye disease. [2022]Teprotumumab, a novel IGF-1R antibody was recently shown to significantly reduce the signs of active Thyroid eye disease (TED). The current study reviews its efficacy in chronic TED.
A New Era in the Treatment of Thyroid Eye Disease. [2020]Improved understanding of thyroid eye disease (TED) pathogenesis has facilitated identification of a targeted molecular approach for TED treatment offering the potential to halt or slow disease progression in a nonsurgical manner. Herein, we provide a summary of the current knowledge of TED management, followed by discussion of a novel insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody and its potential to change the course of the disease.
Association of Patient Age and the Thyroid Eye Disease-Clinical Activity Score. [2023]To investigate the association between age and clinical activity score (CAS) in patients with active, untreated thyroid eye disease.
Linsitinib, an IGF-1R inhibitor, attenuates disease development and progression in a model of thyroid eye disease. [2023]Graves' disease (GD) is an autoimmune disorder caused by autoantibodies against the thyroid stimulating hormone receptor (TSHR) leading to overstimulation of the thyroid gland. Thyroid eye disease (TED) is the most common extra thyroidal manifestation of GD. Therapeutic options to treat TED are very limited and novel treatments need to be developed. In the present study we investigated the effect of linsitinib, a dual small-molecule kinase inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) and the Insulin receptor (IR) on the disease outcome of GD and TED.
Inhibition of TSH/IGF-1 Receptor Crosstalk by Teprotumumab as a Treatment Modality of Thyroid Eye Disease. [2022]We previously presented evidence that TSH receptor (TSHR)-stimulating autoantibodies (TSAbs) bind to and activate TSHRs but do not bind to IGF1 receptors (IGF1Rs). Nevertheless, we showed that IGF1Rs were involved in thyroid eye disease (TED) pathogenesis because TSAbs activated crosstalk between TSHR and IGF1R. Teprotumumab, originally generated to inhibit IGF1 binding to IGF1R, was recently approved for the treatment of TED (Tepezza).
Teprotumumab for chronic thyroid eye disease. [2022]To describe the treatment of nine patients with chronic, low clinical activity score thyroid eye disease with teprotumumab.
Effect of teprotumumab on intraocular pressure in thyroid-associated ophthalmopathy. [2022]To examine changes in intraocular pressure (IOP) in patients with thyroid eye disease (TED) following teprotumumab.