The trial is taking place at:
U

University of Pisa | Department of Dermatology

Veeva-enabled site

A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)

S

Sling Therapeutics

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Thyroid Diseases
Graves Ophthalmopathy
IGF1R
Orbital Diseases
Thyroid Eye Disease
Eye Diseases
Endocrine System Diseases
Graves Orbitopathy
Thyroid Associated Ophthalmopathy
Proptosis
Hashimoto
Exophthalmos

Treatments

Drug: Linsitinib
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05276063
VGN-TED-301

Details and patient eligibility

About

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).

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

75 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo Arm
Treatment:
Drug: Placebo
Low Dose
Active Comparator group
Description:
Active Arm Low Dose Linsitinib
Treatment:
Drug: Linsitinib
High Dose
Active Comparator group
Description:
Active Arm High Dose Linsitinib
Treatment:
Drug: Linsitinib

Trial contacts and locations

30

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Central trial contact

Cathy Radovich; Robin Schmidt

Data sourced from clinicaltrials.gov

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