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

Phase 2

Recruiting

• Conditions: Exophthalmos; Eye Diseases; Proptosis; Thyroid Eye Disease; Graves Orbitopathy; Thyroid Associated Ophthalmopathy; Graves Ophthalmopathy; Orbital Diseases; Endocrine System Diseases; Thyroid Diseases
• Interventions: Drug: linsitinib

• Registration Number: NCT06112340
• Lead Sponsor: Sling Therapeutics, Inc.

Brief Summary

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	linsitinib	Active Arm Low Dose Linsitinib
High Dose	linsitinib	Active Arm High Dose Linsitinib

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects who are Proptosis Responders at Week 24	24 weeks	Percentage of subjects with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Proptosis to Week 24 (Study Eye)	24 weeks	Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24	24 weeks
Percentage of Subjects who are Overall Responders at Week 24	24 weeks	Percentage of Subjects with a response of ≥ 2 mm reduction of proptosis at Week 24 as determined by exophthalmometer
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)	24 weeks

Trial Locations

Locations (2)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

West Virginia University Eye Institute; 🇺🇸 Morgantown, West Virginia, United States