Linsitinib in moderate to severe Thyroid Eye Disease (TED)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, interventional trial evaluates the safety and effectiveness of linsitinib versus placebo in adults with active moderate to severe TED. Eligible participants have Graves' disease and/or autoimmune Hashimoto's with active eye disease, a CAS of 3 or more, and thyroid function that is controlled or near-normal. Participants will be randomly assigned to receive either linsitinib or placebo and will be monitored for changes in eye symptoms and overall tolerability. The study is conducted at three U.S. sites and is sponsored by Sling Therapeutics, Inc. The trial aims to determine if targeted therapy can improve quality of life and reduce eye-related morbidity in TED.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must be ≥ 18 years of age at Screening
2. 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.
3. 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.
4. 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.
5. 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:

1. Any progressing optic neuropathy due to TED that has worsened in the last 6 months in the opinion of the investigator.
2. Corneal decompensation unresponsive to medical management.
3. Previous orbital irradiation or orbital surgery in either eye.
4. 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.
5. Prior IGF-1R inhibitor therapy for any condition.

Where it's running

• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• Thrive Health Research LLC
  Beverly Hills, California, United States Recruiting
• Alliance Research Institute
  Canoga Park, California, United States Recruiting
• Pasadena Clinical Trials
  Pasadena, California, United States Recruiting
• Silkiss Eye Surgery
  San Francisco, California, United States Recruiting
• Advancing Research International, LLC
  Santa Monica, California, United States Recruiting

Study contacts

• Study coordinator: Cathy Radovich
• Email: cathy.radovich@slingtx.com
• Phone: (734) 223-1786

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating linsitinib for thyroid eye disease

  This study is testing if a new drug called linsitinib can help people with moderate to severe thyroid eye disease who haven't improved with other treatments.

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• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

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• MHB018A injections for chronic moderate-to-severe thyroid eye disease

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• Treating Active Thyroid Eye Disease with MHB018A vs placebo

  In people with active moderate-to-severe TED, this study tests whether an antibody called MHB018A can help reduce eye inflammation and swelling compared with a placebo.

  Recruiting Phase 3 Minghui Pharmaceutical (Hangzhou) Ltd · Coral Gables, Florida · NCT07622108

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.