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

Eye Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112340
• Other study ID #: VGN-TED-302
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 11, 2023
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Sling Therapeutics, Inc.
• Contact: Cathy Radovich
• Phone: 734-887-9192
• Email: info[@]slingtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocrine System Diseases
• Exophthalmos
• Eye Diseases
• Graves Ophthalmopathy
• Graves Orbitopathy
• Hashimoto
• Orbital Diseases
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• linsitinib
Study medication taken twice daily by mouth

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	West Virginia University Eye Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Sling Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects who are Proptosis Responders at Week 24	Percentage of subjects with a = 2 mm reduction of proptosis from baseline as determined by exophthalmometer	24 weeks
Secondary	Change from Baseline in Proptosis to Week 24 (Study Eye)	Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer	24 weeks
Secondary	Percentage of Subjects who are Overall Responders at Week 24	Percentage of Subjects with a response of = 2 mm reduction of proptosis at Week 24 as determined by exophthalmometer	24 weeks
Secondary	Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)		24 weeks
Secondary	Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24		24 weeks