Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 treatment of subjects with active, moderate to severe thyroid eye disease (TED).
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.