Suspended
LIDSA Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
What is being tested
Linsitinib
+ Placebo
Drug
Who is being recruted
Autoimmune Diseases+14
+ Endocrine System Diseases
+ Exophthalmos
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2 & 3
Interventional
Study Start: July 2022
Summary
Principal SponsorSling Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2022
Actual date on which the first participant was enrolled.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).
Official TitleA Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Principal SponsorSling Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Autoimmune DiseasesEndocrine System DiseasesExophthalmosEye DiseasesGoiterGraves DiseaseHyperthyroidismImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOrbital DiseasesThyroid DiseasesThyroiditisThyroiditis, AutoimmuneEye Diseases, HereditaryGenetic Diseases, InbornGraves OphthalmopathyHashimoto Disease
Criteria
4 inclusion criteria required to participate
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.
5 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorActive Arm High Dose Linsitinib
Group II
Active ComparatorActive Arm Low Dose Linsitinib
Group III
PlaceboPlacebo Arm
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 30 locations
Suspended
Suspended
Center for Excellence in Eye Care
Miami, United StatesSuspended
Sarasota Retina Institute
Sarasota, United StatesSuspended
Chicago Oculofacial Plastic Surgery
Chicago, United StatesSuspended30 Study Centers