CTIS2022-502812-35-00
Recruiting
Phase 1
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) - VGN-TED-302
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sling Therapeutics Inc.
- Enrollment
- 75
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject who completed the 24\-week double\-mask period of VGN\-TED\-301 and are proptosis nonresponders (\< 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. 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.
Exclusion Criteria
- •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\. Subjects will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the study protocol or have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk. Please refer to the protocol for a complete list of exclusion criteria.
Outcomes
Primary Outcomes
Not specified
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