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A Study to Evaluate Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
EU CTIS ID: 2022-502812-35-00
What this study is testing
to study the effect of linsitinib on the proptosis responder rate at Extension Study Week 24 for eligible subjects completing Week 24 of the lead-in study VGN-TED-301. Responder rate is the percentage of subjects with a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥2 mm increase) of proptosis in the contralateral non-study eye.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (see Section 3.1.2) 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. If T3 and/or T4 values are outside protocol limits, the patient may be eligible for a re-test after consultation with the medical monitor. 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. Please refer to the protocol for a complete list of inclusion criteria.
You likely can't join if
- 1. QTcF prolongation at Baseline; mean QTcF interval > 450msec (males); and >470 msec (females) and TdP risk factors, e.g., hypokalemia and family history of Congenital Long QT syndrome. 2. Alanine aminotransferase (alt) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) according to age at Baseline. 3. Serum creatinine > 2 x ULN for the reference range laboratory according to age at Baseline. 4. Prior IGF-1R inhibitor therapy for any condition. Please refer to the protocol for a complete list of exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.