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Recruiting NCT07753603

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

Phase III Interventional Thyroid Eye Disease, TED Graves Orbitopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: linsitinib, Placebo.
Who it may be relevant to
Registry conditions: Thyroid Eye Disease, TED, Graves Orbitopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

Overview

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).

Interventions

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

Primary outcome measures

  • Measure percentage of participants who are Proptosis Responders at Week 24 [Time frame: 24 weeks]
Secondary outcome measures (4)
  • Mean change from Baseline in Proptosis to Week 24 [Time frame: 24 Weeks]
  • Evaluate the effect of linsitinib 150 mg twice daily versus placebo on the overall responder rate 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. [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. [Time frame: 24 Weeks]

Eligibility criteria

Inclusion criteria

  • 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.
  • 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

  • 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.
  • Prior IGF-1R inhibitor therapy for any condition.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Advancing Research International — Las Vegas

Identifiers

NCT: NCT07753603 · SLG-TED-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗