RECRUITING

A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Quick Facts

Study Start:2023-10-11
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06112340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Subject has not received any treatment for TED since Week 24 of VGN-TED-301
  3. * 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
  4. * 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
  1. * The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.

Contacts and Locations

Study Contact

Cathy Radovich
CONTACT
734-887-9192
info@slingtx.com
Robin Schmidt
CONTACT
734-887-9192
info@slingtx.com

Study Locations (Sites)

Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Sling Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-10-11
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

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