Trial record 1 of 1 for:
VGN-TED-301
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (LIDS)
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| ClinicalTrials.gov Identifier: NCT05276063 |
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Recruitment Status :
Recruiting
First Posted : March 11, 2022
Last Update Posted : January 31, 2023
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Sponsor:
Sling Therapeutics, Inc.
Information provided by (Responsible Party):
Sling Therapeutics, Inc.
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo Arm
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Drug: Placebo
Placebo taken twice daily by mouth |
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Active Comparator: Low Dose
Active Arm Low Dose Linsitinib
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Drug: Linsitinib
Study medication taken twice daily by mouth |
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Active Comparator: High Dose
Active Arm High Dose Linsitinib
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Drug: Linsitinib
Study medication taken twice daily by mouth |
Primary Outcome Measures :
- Percentage of Subjects who are Proptosis Responders at Week 24 [ Time Frame: 24 weeks ]
Secondary Outcome Measures :
- Change from Baseline in Proptosis to Week 24 (Study Eye) [ Time Frame: 24 weeks ]
- Percentage of Subjects who are Diplopia Responders at Week 24 [ Time Frame: 24 weeks ]
- Percentage of Subjects who are Overall Responders at Week 24 [ Time Frame: 24 weeks ]
- Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye) [ Time Frame: 24 weeks ]
- Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24. [ Time Frame: 24 weeks ]
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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 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.
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
| Contact: Cathy Radovich | 734-887-9192 | info@slingtx.com | |
| Contact: Robin Schmidt | 734-887-9192 | info@slingtx.com |
Locations
Show 23 study locations
Sponsors and Collaborators
Sling Therapeutics, Inc.
| 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: | January 31, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Sling Therapeutics, Inc.:
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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 |