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

NCT06112340 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-02-25

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

linsitinib

Study medication taken twice daily by mouth

Sponsors & Collaborators

  • Sling Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112340 on ClinicalTrials.gov