What side effects are associated with this type of intervention?

Common treatments for orbital diseases, such as Linsitinib and Teprotumumab, which are IGF-1R inhibitors, can have several side effects. For Teprotumumab, reported side effects include muscle spasms, nausea, alopecia, diarrhea, fatigue, hyperglycemia, and hearing impairment. Systemic treatments for orbital diseases may also cause ocular side effects like dry eye, optic neuropathy, and retinal toxicity. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

FDA approvals for the treatment of orbital diseases, particularly those involving IGF-1R and IR inhibitors like Linsitinib, are limited. However, Teprotumumab, an IGF-1R inhibitor, has been approved for the treatment of Thyroid Eye Disease (TED). Teprotumumab works by inhibiting the IGF-1R pathway, which is similar to the mechanism of action being studied for Linsitinib. This approval represents a significant advancement in the treatment of TED, providing a targeted therapeutic option for patients with this condition.

What other types of research exist?

Promising novel alternatives to Linsitinib for treating orbital diseases, particularly Thyroid Eye Disease (TED), include Teprotumumab, a monoclonal antibody targeting the IGF-1R, which has shown significant efficacy in reducing proptosis and inflammation in TED patients. Another potential alternative is Rituximab, a monoclonal antibody against CD20, which has been explored for its immunomodulatory effects in TED. Both therapies have demonstrated promising results in clinical trials and could be considered for treatment in 2024.

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Tyrosine Kinase Inhibitor

Linsitinib for Thyroid Eye Disease

Q: What is the mechanism of action of this treatment?

Common treatments for orbital diseases often target the underlying inflammatory and autoimmune processes. Linsitinib, an IGF-1R and IR inhibitor, works by blocking the insulin-like growth factor 1 receptor (IGF-1R) and insulin receptor (IR), which are involved in cell growth and inflammation. By inhibiting these receptors, Linsitinib can reduce inflammation and tissue remodeling in the orbit, which is crucial for patients with conditions like thyroid eye disease (TED). This is important because reducing inflammation can alleviate symptoms such as proptosis (eye bulging), pain, and vision impairment, thereby improving the patient's quality of life.

Phase 2 & 3

Recruiting

Research Sponsored by Sling Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for Linsitinib are not listed here, common ones may include digestive issues, fatigue, changes in blood sugar levels, and possible allergic reactions. Each patient's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I completed 24 weeks of VGN-TED-301 without significant eye bulging reduction or my condition worsened after initial improvement.

Select...

I haven't had treatment for TED since Week 24 of VGN-TED-301.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Subjects who are Proptosis Responders at Week 24

Secondary study objectives

Change from Baseline in Proptosis to Week 24 (Study Eye)

Percentage of Subjects who are Overall Responders at Week 24

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for orbital diseases often target the underlying inflammatory and autoimmune processes. Linsitinib, an IGF-1R and IR inhibitor, works by blocking the insulin-like growth factor 1 receptor (IGF-1R) and insulin receptor (IR), which are involved in cell growth and inflammation. By inhibiting these receptors, Linsitinib can reduce inflammation and tissue remodeling in the orbit, which is crucial for patients with conditions like thyroid eye disease (TED). This is important because reducing inflammation can alleviate symptoms such as proptosis (eye bulging), pain, and vision impairment, thereby improving the patient's quality of life.

High-dose intravenous therapy with 7S immunoglobulins in autoimmune endocrine ophthalmopathy.The role of tocilizumab in the treatment of inflammatory diseases of the eye and orbit: A useful alternative.[Mucous membrane pemphigoid with ocular involvement. Part II: therapy].