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

Sponsor

Sling Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06112340

Collaborator

(none)

Enrollment

Locations

Arms

31.7

Anticipated Duration (Months)

37.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

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	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

Actual Study Start Date :

Oct 11, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline in Proptosis to Week 24 (Study Eye) [24 weeks]
Change from baseline in reduction of proptosis from baseline as determined by exophthalmometer
Percentage of Subjects who are Overall Responders at Week 24 [24 weeks]
Percentage of Subjects with a response of ≥ 2 mm reduction of proptosis at Week 24 as determined by exophthalmometer
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye) [24 weeks]
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24 [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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