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

July 20, 2023 updated by: Sling Therapeutics, Inc.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Recruiting
        • Vancouver Coastal Health Eye Care Center
        • Contact:
  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Endocrinology Pawilione Zonda
        • Contact:
      • Pisa, Italy
      • Pisa, Italy
        • Recruiting
        • AOU Pisana
        • Contact:
  • Spain
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28034
      • Madrid, Spain, 28006
  • United Kingdom
      • Camberley, United Kingdom, GU16 7UJ
      • Cardiff, United Kingdom, CF14 4XN
      • London, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital NIHR Clinical Research Facility
        • Contact:
  • United States
    • California
      • Beverly Hills, California, United States, 90210
      • La Jolla, California, United States, 92093
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90095
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Byers Eye Institute - Stanford University
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
      • Sarasota, Florida, United States, 34239
    • Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
      • Livonia, Michigan, United States, 48152
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Washington University in St. Louis/Barnes Jewish Hospital
        • Contact:
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
    • Utah
      • Salt Lake City, Utah, United States, 84102
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
    • Wisconsin
      • Madison, Wisconsin, United States, 57305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Arm
Drug: Placebo
Placebo taken twice daily by mouth
Active Comparator: Low Dose
Active Arm Low Dose Linsitinib
Drug: Linsitinib
Study medication taken twice daily by mouth
Active Comparator: High Dose
Active Arm High Dose Linsitinib
Drug: Linsitinib
Study medication taken twice daily by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Subjects who are Proptosis Responders at Week 24
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Proptosis to Week 24 (Study Eye)
Time Frame: 24 weeks
24 weeks
Percentage of Subjects who are Diplopia Responders at Week 24
Time Frame: 24 weeks
24 weeks
Percentage of Subjects who are Overall Responders at Week 24
Time Frame: 24 weeks
24 weeks
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
Time Frame: 24 weeks
24 weeks
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sling Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGN-TED-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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