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Trial record 1 of 1 for:    VGN-TED-301
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A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05276063
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Sling Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Thyroid Eye Disease Graves Orbitopathy Endocrine System Diseases Eye Diseases Thyroid Associated Ophthalmopathy Graves Ophthalmopathy Thyroid Diseases Orbital Diseases Proptosis IGF1R Exophthalmos Hashimoto Drug: Linsitinib Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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




Primary Outcome Measures :
  1. Percentage of Subjects who are Proptosis Responders at Week 24 [ Time Frame: 24 weeks ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (defined as normal TSH) or, have subclinical hyperthyroidism (defined as normal FT4 and FT3 with TSH below the normal range).
  • Does not require immediate surgery, radiotherapy 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 surgery.
  • Any steroid 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05276063


Contacts
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Contact: Cathy Radovich 734-887-9192 info@slingtx.com
Contact: Robin Schmidt 734-887-9192 info@slingtx.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Sling Therapeutics, Inc.
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Responsible Party: Sling Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05276063    
Other Study ID Numbers: VGN-TED-301
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sling Therapeutics, Inc.:
Thyroid Associated Ophthalmopathies
Additional relevant MeSH terms:
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Eye Diseases
Graves Ophthalmopathy
Exophthalmos
Orbital Diseases
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Genetic Diseases, Inborn
Goiter
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases