Status:
ACTIVE_NOT_RECRUITING
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Lead Sponsor:
Sling Therapeutics, Inc.
Conditions:
Thyroid Eye Disease
Graves Orbitopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the trea...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
- Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
- 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 Screening.
- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
Exclusion
- Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- Corneal decompensation unresponsive to medical management.
- Previous orbital irradiation or orbital surgery.
- Any glucocorticoid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to \>= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
- Prior IGF-1R inhibitor therapy for any condition.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05276063
Start Date
July 1 2022
End Date
September 1 2026
Last Update
January 29 2025
Active Locations (30)
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1
Thrive Health Research
Beverly Hills, California, United States, 90210
2
UC San Diego Health
La Jolla, California, United States, 92093
3
UCLA
Los Angeles, California, United States, 90095
4
Byers Eye Institute - Stanford University
Palo Alto, California, United States, 94303