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NCT Number: NCT06112340

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

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.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Graves Orbitopathy Hashimoto Hashimoto Disease Hyperthyroidism IGF1R Immune System Diseases Orbital Diseases Proptosis Thyroid Associated Ophthalmopathy Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bascom Palmer Eye Institute, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

linsitinib

Drug

Study medication taken twice daily by mouth

Primary outcomes

  1. Percentage of Subjects who are Proptosis Responders at Week 24

    Time frame: 24 weeks

    Percentage of subjects with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer

Secondary outcomes

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

    Time frame: 24 weeks

    Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer

  2. Percentage of Subjects who are Overall Responders at Week 24

    Time frame: 24 weeks

    Percentage of Subjects with a response of ≥ 2 mm reduction of proptosis at Week 24 as determined by exophthalmometer

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

    Time frame: 24 weeks

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

    Time frame: 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Cathy Radovich

CONTACT

[email protected]

734-887-9192

Robin Schmidt

CONTACT

[email protected]

734-887-9192

Sponsors and collaborators

Lead sponsor

Sling Therapeutics, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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