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

NCT06112340 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: VGN-TED-302
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  24 weeks

• Percentage of Subjects who are Overall Responders at Week 24

  24 weeks

• 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

Study Arms (2)

Low Dose

ACTIVE COMPARATOR

Active Arm Low Dose Linsitinib

Drug: linsitinib

High Dose

ACTIVE COMPARATOR

Active Arm High Dose Linsitinib

Drug: linsitinib

Interventions

linsitinib DRUG

Study medication taken twice daily by mouth

High Dose; Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Sling Therapeutics, Inc.: lead

Study Sites (2)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

West Virginia University Eye Institute

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy; Endocrine System Diseases; Eye Diseases; Thyroid Diseases; Orbital Diseases; Exophthalmos; Hashimoto Disease

Interventions

3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Graves Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Thyroiditis, Autoimmune; Thyroiditis

Central Study Contacts

Cathy Radovich

CONTACT

734-887-9192; info@slingtx.com

Robin Schmidt

CONTACT

734-887-9192; info@slingtx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 1, 2023
• Study Start: October 11, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (2)