Thyroid Eye Disease, TED study: Linsitinib
Official title Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
ClinicalTrials.gov ID: NCT07753603
What this study is testing
What is linsitinib?
an investigational oral medicine being studied as a potential treatment for moderate to severe Thyroid Eye Disease (TED) is designed to block the activity of the insulin-like growth factor 1 receptor (IGF-1R) and related pathways that may contribute to eye inflammation
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how well linsitinib works, how safe it is, and how well participants tolerate it.
- Who it's for
- Adults who have moderate to severe active thyroid eye disease.
- What's involved
- Participants will take the study drug linsitinib and attend study visits for monitoring and tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Participants must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine...
- Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not...
You likely can't join if
- 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...
- Prior IGF-1R inhibitor therapy for any condition.
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, Arizona, United States
- Beverly Hills, California, United States
- Canoga Park, California, United States
- Pasadena, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Coral Gables, Florida, United States
- Jacksonville, Florida, United States
- East Weymouth, Massachusetts, United States
- Livonia, Michigan, United States
- Las Vegas, Nevada, United States
- Reno, Nevada, United States
- Somerset, New Jersey, United States
- Asheville, North Carolina, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, Arizona, United States; Beverly Hills, California, United States; Canoga Park, California, United States; Pasadena, California, United States; San Francisco, California, United States; Santa Monica, California, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.