Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

ConditionsThyroid Eye Disease, TED Graves Orbitopathy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorSling Therapeutics, Inc.

About this trial

The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be ≥ 18 years of age at Screening

Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.

Moderate to severe active TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 15 months prior to the Screening visit and usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.

Participants 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 of the central laboratory) at Screening.

Disqualifiers

Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.

Corneal decompensation unresponsive to medical management.

Previous orbital irradiation or orbital surgery in either eye.

Any glucocorticoid use (IV or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone or equivalent for the treatment of TED within 8 weeks of Screening.

Trial design

Design model

Parallel

Treatments tested in this trial

linsitinib
Drug
150 mg linsitinib is taken twice daily by mouth for 24 weeks
Placebo
Drug
0 mg placebo taken twice daily by mouth for 24 weeks

Treatment groups

130 Participants

are divided into 3 treatment groups

Group A: Double-mask Treatment ArmExperimental treatment 1 intervention

Group B: Double-mask Placebo ArmPlacebo comparator 1 intervention

Group C: Open-label Extension Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Measure percentage of participants who are Proptosis Responders at Week 24

The proptosis responder rate is the percentage of participants with a ≥ 2 mm reduction of proptosis from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.

Time frame

24 weeks

Secondary outcomes

Mean change from Baseline in Proptosis to Week 24

Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.

Time frame

24 Weeks

Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate at Week 24

Overall responder rate (percentage of participants with ≥ 2-point reduction in 7 point CAS and ≥ 2 mm reduction in proptosis from Baseline in the primary study eye), provided there is no corresponding deterioration (≥ 2-point/mm increase) in CAS or proptosis in the contralateral non-study eye at Week 24.

Time frame

24 Weeks

Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the mean change from Baseline to Week 24 in the GO-QoL questionnaire overall score.

Mean change from Baseline to Week 24 in the Graves' Orbitopathy Quality of Life questionnaire (GO-QoL) questionnaire overall score (0-100 where higher scores are a better outcome).

Time frame

24 Weeks

Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.

Percentage of participants with a CAS value of 0 or 1 at Week 24 in the primary study eye.

Time frame

24 Weeks

Other outcomes

To assess the safety and tolerability of linsitinib 150 mg twice daily as compared to placebo over a 24-week period.

Incidence of TEAEs (defined as AEs that begin or worsen after the first dose of study drug), treatment-emergent SAEs, deaths, discontinuation due to AEs, clinical safety laboratory results, vital signs, physical and ophthalmic examinations, and ECG parameters.

Time frame

24 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sling Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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