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

Last updated: February 24, 2025
Sponsor: Sling Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Dry Eye Disease

Treatment

linsitinib

Clinical Study ID

NCT06112340
VGN-TED-302
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Subject who completed the 24-week double-mask period of VGN-TED-301 and areproptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24of VGN-TED-301 study or proptosis responders at Week 24 who relapse during theFollow-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 orhave mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and freetriiodothyronine levels [FT3] <50% above or below the normal limits) at Baseline.Every effort should be made to correct mild hypo- or hyperthyroidism promptly andmaintain the euthyroid state for the duration of the clinical trial

  • Does not require immediate ophthalmic surgery, radiotherapy to orbits or otherophthalmological intervention at the time of Baseline and is not planning for anysuch treatment during the course of the study

Exclusion

Exclusion Criteria:

  • The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: linsitinib
Phase: 2/3
Study Start date:
October 11, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Bascom Palmer Eye Institute

    Miami, Florida 33136
    United States

    Active - Recruiting

  • West Virginia University Eye Institute

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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