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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Thyroid Eye Disease, Graves Orbitopathy, Endocrine System Diseases, Eye Diseases, Thyroid Associated Ophthalmopathy, Graves Ophthalmopathy, Thyroid Diseases, Orbital Diseases, Proptosis, IGF1R, Exophthalmos, Hashimoto

In brief

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).

Key facts

Study ID

NCT05276063

Run by

Sling Therapeutics, Inc.

People needed

90

Starts

2022-07-01

Expected to finish

2026-09-01

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Thrive Health Research — Beverly Hills, California, United States
• UC San Diego Health — La Jolla, California, United States
• UCLA — Los Angeles, California, United States
• Byers Eye Institute - Stanford University — Palo Alto, California, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Center for Excellence in Eye Care — Miami, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Chicago Oculofacial Plastic Surgery — Chicago, Illinois, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Mass Eye and Ear — Boston, Massachusetts, United States
• Kellogg Eye Center — Ann Arbor, Michigan, United States
• Kahana Oculoplastic & Orbital Surgery — Livonia, Michigan, United States
• Washington University in St. Louis/Barnes Jewish Hospital — Creve Coeur, Missouri, United States
• Columbia University — New York, New York, United States
• Wake Forest Baptist Health Eye Center — Winston-Salem, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Neuro-Eye Clinical Trials, Inc. — Bellaire, Texas, United States
• Eyelid Center of Utah — Salt Lake City, Utah, United States
• West Virginia University Eye Institute — Morgantown, West Virginia, United States
• Vancouver Coastal Health Eye Care Center — Vancouver, British Columbia, Canada
• Toronto Retina Institute — North York, Canada
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Endocrinology Pawilione Zonda — Milan, Italy
• AOU Pisana — Pisa, Italy
• University of Pisa — Pisa, Italy
• Hospital Universitari de Bellvitge — Barcelona, Spain

Full record on ClinicalTrials.gov

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