Extension Study of Two Doses of Linsitinib in Subjects Wi... | NCT06112340

Studies
Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

NCT06112340

Sponsor

Sling Therapeutics, Inc.

Status

Recruiting

Last Update Posted

Feb 25, 2025Actual

Enrollment

75Estimated

Phase

Phase 2Phase 3

Conditions

Thyroid Eye Disease
Graves Orbitopathy
Endocrine System Diseases
Eye Diseases
Thyroid Associated Ophthalmopathy
Graves Ophthalmopathy
Thyroid Diseases
Orbital Diseases
Proptosis
IGF1R
Exophthalmos
Hashimoto

Interventions

linsitinib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 11, 2023Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Oct 16, 2023

First Submission Date that Met QC Criteria

Oct 31, 2023

First Posted Date

Nov 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2025

Last Update Posted Date

Feb 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose	Active Comparator	Active Arm Low Dose Linsitinib	Drug: linsitinib
High Dose	Active Comparator	Active Arm High Dose Linsitinib	Drug: linsitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
linsitinib	Drug	Study medication taken twice daily by mouth	High Dose Low Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects who are Proptosis Responders at Week 24	Percentage of subjects with a ≥ 2 mm reduction of proptosis from baseline as determined by exophthalmometer	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Proptosis to Week 24 (Study Eye)	Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer	24 weeks
Percentage of Subjects who are Overall Responders at Week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301
Subject has not received any treatment for TED since Week 24 of VGN-TED-301
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 Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial
Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study

Exclusion Criteria:

The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cathy Radovich	Contact	734-887-9192		info@slingtx.com
Robin Schmidt	Contact	734-887-9192		info@slingtx.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bascom Palmer Eye Institute	Recruiting	Miami	Florida	33136	United States

ID	Term
D049970	Graves Ophthalmopathy
D004700	Endocrine System Diseases
D005128	Eye Diseases
D013959	Thyroid Diseases
D009916	Orbital Diseases
D005094	Exophthalmos
D050031	Hashimoto Disease

ID	Term
D015785	Eye Diseases, Hereditary
D006111	Graves Disease
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006042	Goiter
D006980	Hyperthyroidism
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D013967	Thyroiditis, Autoimmune
D013966	Thyroiditis