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A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Sponsor: Sling Therapeutics, Inc.
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).
Official title: A 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-07-01
Completion Date
2026-09
Last Updated
2025-01-29
Healthy Volunteers
No
Conditions
Interventions
Linsitinib
Study medication taken twice daily by mouth
Placebo
Placebo taken twice daily by mouth
Locations (30)
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
Hospital La Princesa
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Frimley Health Foundation Trust
Camberley, United Kingdom
Cardiff University
Cardiff, United Kingdom
Moorfields Eye Hospital NIHR Clinical Research Facility
London, United Kingdom