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

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)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06112340

Enrollment

Registered

2023-11-01

Start date

2023-10-11

Completion date

2026-06-30

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine System Diseases, Exophthalmos, Eye Diseases, Graves Ophthalmopathy, Graves Orbitopathy, Hashimoto, IGF1R, Orbital Diseases, Proptosis, Thyroid Associated Ophthalmopathy, Thyroid Diseases, Thyroid Eye Disease

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.

Interventions

DRUGlinsitinib

Study medication taken twice daily by mouth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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	—
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24	24 weeks	—

Countries

United States

Contacts

Primary ContactCathy Radovich

info@slingtx.com734-887-9192

Backup ContactRobin Schmidt