NCT06112340RecruitingPhase 2
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)
Sling Therapeutics, Inc.2 sites in 1 country75 target enrollmentStarted: October 11, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Sling Therapeutics, Inc.
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Percentage of Subjects who are Proptosis Responders at Week 24
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Low Dose
Active Comparator
Active Arm Low Dose Linsitinib
Intervention: linsitinib (Drug)
High Dose
Active Comparator
Active Arm High Dose Linsitinib
Intervention: linsitinib (Drug)
Outcomes
Primary Outcomes
Percentage of Subjects who are Proptosis Responders at Week 24
Time Frame: 24 weeks
Percentage of subjects with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer
Secondary Outcomes
- Change from Baseline in Proptosis to Week 24 (Study Eye)(24 weeks)
- Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24(24 weeks)
- Percentage of Subjects who are Overall Responders at Week 24(24 weeks)
- Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)(24 weeks)
Investigators
Study Sites (2)
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