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

Part of paid clinical trials in Miami, Florida.

Sponsor
Sling Therapeutics, Inc.
Study ID
NCT06112340
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • linsitinib — DRUG
    Study medication taken twice daily by mouth

Study Details

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.

Key Dates

Start date
Oct 11, 2023
Status verified
Feb 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low Dose
    Active Arm Low Dose Linsitinib
  • Active Comparator: High Dose
    Active Arm High Dose Linsitinib

Primary Outcome Measure

Percentage of Subjects who are Proptosis Responders at Week 24 [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Bascom Palmer Eye InstituteMiamiFlorida33136
Jennifer Gomez
[email protected]
West Virginia University Eye InstituteMorgantownWest Virginia26506
Athena Echols
[email protected]

Find similar trials in Miami, FL

By research site
Bascom Palmer Eye Institute· Miami, FLWest Virginia University Eye Institute· Morgantown, WV

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