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Tyrosine Kinase Inhibitor

Linsitinib for Thyroid Eye Disease

Q: Are there openings remaining in this clinical investigation?

<p>As per details found on clinicaltrials.gov, this trial is actively welcoming participants. It was initially launched on November 10th 2023 and the specifications were last modified at the end of October 2023.</p>

Q: How many individuals are being incorporated into this clinical experiment?

<p>Affirmative. Clinicaltrials.gov clearly states that this clinical trial, which was originally posted on October 11th 2023, is actively seeking out participants. It requires 75 patients from two different medical centres to participate in the study.</p>

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

Study Summary

This trial seeks to continue to assess the effects of an experimental drug on patients with eye inflammation who didn't respond to other treatments.

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.Check my eligibility

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.See study design

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.

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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Subjects who are Proptosis Responders at Week 24

Secondary outcome measures

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

Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24

Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)

+1 more

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

Find a Location

Who is running the clinical trial?

Sling Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

75 Total Patients Enrolled

1 Trials studying Orbital Diseases

75 Patients Enrolled for Orbital Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there openings remaining in this clinical investigation?

"As per details found on clinicaltrials.gov, this trial is actively welcoming participants. It was initially launched on November 10th 2023 and the specifications were last modified at the end of October 2023."

Answered by AI

How many individuals are being incorporated into this clinical experiment?

"Affirmative. Clinicaltrials.gov clearly states that this clinical trial, which was originally posted on October 11th 2023, is actively seeking out participants. It requires 75 patients from two different medical centres to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

2023. "A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06112340.

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