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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Low Dose 		Active Arm Low Dose Linsitinib
  • Drug: linsitinib
    Study medication taken twice daily by mouth
Active Comparator
High Dose 		Active Arm High Dose Linsitinib
  • Drug: linsitinib
    Study medication taken twice daily by mouth

Recruiting Locations

Bascom Palmer Eye Institute
Miami, Florida 33136
Contact:
Jennifer Gomez
jxg1540@miami.edu

West Virginia University Eye Institute
Morgantown, West Virginia 26506
Contact:
Athena Echols
athena.sparks@wvumedicine.org

More Details

Status
Recruiting
Sponsor
Sling Therapeutics, Inc.

Study Contact

Cathy Radovich
734-887-9192
info@slingtx.com