Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: linsitinib.
- Who it may be relevant to
- Registry conditions: Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug linsitinib
Study medication taken twice daily by mouth
Primary outcome measures
- Percentage of Subjects who are Proptosis Responders at Week 24 [Time frame: 24 weeks]
Secondary outcome measures (4)
- Change from Baseline in Proptosis to Week 24 (Study Eye) [Time frame: 24 weeks]
- Percentage of Subjects who are Overall Responders at Week 24 [Time frame: 24 weeks]
- Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye) [Time frame: 24 weeks]
- Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24 [Time frame: 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Bascom Palmer Eye Institute — Miami
- West Virginia University Eye Institute — Morgantown
Identifiers
NCT: NCT06112340 · VGN-TED-302