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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05276063
Other study ID # VGN-TED-301
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2022
Est. completion date September 2026

Study information

Verified date May 2024
Source Sling Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date September 2026
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design


Intervention

Drug:
Linsitinib
Study medication taken twice daily by mouth
Placebo
Placebo taken twice daily by mouth

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Sling Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects who are Proptosis Responders at Week 24 24 weeks
Secondary Change from Baseline in Proptosis to Week 24 (Study Eye) 24 weeks
Secondary Percentage of Subjects who are Diplopia Responders at Week 24 24 weeks
Secondary Percentage of Subjects who are Overall Responders at Week 24 24 weeks
Secondary Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye) 24 weeks
Secondary Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24. 24 weeks
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