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Clinical Trials in the USA / NCT06112340
Recruiting Phase 2/3

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

NCT06112340 · tracked via the Priya Life Science USA tracker
Sponsor
Sling Therapeutics, Inc.
Phase
Phase 2/3
Started
2023-10-11
Last updated
2025-02-25

Condition(s) studied

Thyroid Eye DiseaseGraves OrbitopathyEndocrine System DiseasesEye DiseasesThyroid Associated OphthalmopathyGraves OphthalmopathyThyroid DiseasesOrbital DiseasesProptosisIGF1RExophthalmosHashimoto

Investigational drug(s) / intervention(s)

linsitinib

linsitinib: Study medication taken twice daily by mouth

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Bascom Palmer Eye Institute Miami Florida Recruiting
West Virginia University Eye Institute Morgantown West Virginia Recruiting

More Sling Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06112340 on ClinicalTrials.gov ↗ ← All trials in the USA