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

Sling Therapeutics

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: linsitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06112340

VGN-TED-302

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

75 participants in 2 patient groups

Low Dose

Active Comparator group

Description:

Active Arm Low Dose Linsitinib

Treatment:

Drug: linsitinib

High Dose

Active Comparator group

Description:

Active Arm High Dose Linsitinib

Treatment:

Drug: linsitinib