Clinical trial NCT06112340: Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Thyroid Eye Disease
Graves Orbitopathy
Endocrine System Diseases
Eye Diseases
Thyroid Associated Ophthalmopathy
Graves Ophthalmopathy
Thyroid Diseases
Orbital Diseases
Proptosis
IGF1R
Exophthalmos
Hashimoto
Lead sponsor: Sling Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Percentage of Subjects who are Proptosis Responders at Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from Baseline in Proptosis to Week 24 (Study Eye)
timeFrame: 24 weeks
measure: Percentage of Subjects who are Overall Responders at Week 24
timeFrame: 24 weeks
measure: Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
timeFrame: 24 weeks
measure: Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
Study officials:
References: