Active not recruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study is looking into a new medicine called linsitinib for people in the UK who have active, moderate to severe Thyroid Eye Disease (TED). TED is an autoimmune condition linked to thyroid issues that can affect the eyes. The study aims to understand how safe linsitinib is, how the body handles it, and how well it works to treat TED symptoms over a period of 24 weeks. Participants will either receive linsitinib or a placebo (a dummy pill with no active medicine). The information gathered will help determine if this new treatment could be a good option for future TED patients.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Sling Therapeutics, Inc.

Enrolment target

Start

01 Jul 2022

Estimated completion

01 Sep 2026

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

What is this study about?

This study is investigating a new oral medication named linsitinib, which directly targets a specific pathway in the body involved in Thyroid Eye Disease (TED). TED is an autoimmune condition, often linked with an overactive thyroid (Graves' disease) or an underactive thyroid (Hashimoto's thyroiditis), where the body's immune system mistakenly attacks the tissues around the eyes. This can lead to swelling, redness, bulging eyes (proptosis or exophthalmos), and sometimes double vision.

The main goal of this research is to see if linsitinib can help reduce the symptoms and signs of active, moderate to severe TED. Researchers are also very interested in understanding how safe the medicine is and how the body processes it. This type of study (Phase 2b/3) means that while we have some initial information about the drug, more detailed research is needed to confirm its effects and safety in a larger group of people. The results could potentially offer a new treatment option for those living with TED.

Participants will be split into groups, with some receiving linsitinib and others receiving a placebo, which looks identical but contains no active medication. This approach helps researchers fairly compare the effects of the new drug. The study will last for 24 weeks, during which scientists will carefully monitor participants' progress and gather important information to assess the medication's effectiveness and safety profile.

Key takeaways

This study is for people with active, moderate to severe Thyroid Eye Disease (TED).
It's testing a new medicine called linsitinib against a dummy pill (placebo).
The main aim is to see if linsitinib is safe and effective for TED.
Participation involves taking daily medication and regular clinic visits for 24 weeks.
You'll be closely monitored by medical professionals if you take part.

Who may be eligible?

To join this study, you need to have been diagnosed with an autoimmune thyroid condition like Graves' Disease or Hashimoto's thyroiditis, along with active, moderate to severe Thyroid Eye Disease (TED). Your TED should have started within the last year, and it should be noticeably affecting your daily life. Your thyroid hormone levels should be mostly stable, not too high or too low, at the start of the study.

There are certain reasons why you wouldn't be able to join. For example, if you've recently had a significant worsening of your vision due to nerve issues, or if you have severe corneal problems that aren't getting better with treatment. You also can't have had radiation treatment or surgery around your eyes in the past, or have received potent steroid treatments for your TED within the last three months. If you've previously taken a type of medicine called an IGF-1R inhibitor for any condition, you won't be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a diagnosis of Graves' Disease or Hashimoto's thyroiditis with active TED?
Did your active TED symptoms start within the last 12 months?
Are your thyroid levels mostly stable or only slightly off-balance?
Have you avoided strong steroid treatments for TED in the last 3 months?
Have you never used an IGF-1R inhibitor type of medication before?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take the study medicine, linsitinib or a placebo (a dummy pill), by mouth twice a day. You will have regular visits to the clinic over a period of 24 weeks. These visits will involve various assessments such as eye exams, blood tests, and possibly questionnaires to track your symptoms and how you are feeling. The doctors and nurses will closely monitor your general health and specifically your eye condition. After the main 24-week treatment period, there will be follow-up visits to ensure your safety and gather long-term information. The total duration of your participation in the study, including follow-up, will be determined by the study design, but the active treatment phase is 24 weeks.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. You might benefit from the new medicine if it proves effective, and you'll receive regular, close medical monitoring for your TED. However, the medicine may not work for everyone, and like all medications, linsitinib could have side effects, some of which might be serious. Because you might receive a placebo, there's a chance you won't get the active medicine. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Thrive Health Research
Verified postcode
Beverly Hills, United States
UC San Diego Health
Verified postcode
La Jolla, United States
UCLA
Verified postcode
Los Angeles, United States
Byers Eye Institute - Stanford University
Verified postcode
Palo Alto, United States
Bascom Palmer Eye Institute
Verified postcode
Miami, United States
Center for Excellence in Eye Care
Verified postcode
Miami, United States
Sarasota Retina Institute
Verified postcode
Sarasota, United States
Chicago Oculofacial Plastic Surgery
Verified postcode
Chicago, United States
Wolfe Eye Clinic
Verified postcode
West Des Moines, United States
Mass Eye and Ear
Verified postcode
Boston, United States
Kellogg Eye Center
Verified postcode
Ann Arbor, United States
Kahana Oculoplastic & Orbital Surgery
Verified postcode
Livonia, United States

Common questions

What is Thyroid Eye Disease (TED)?

TED is an autoimmune condition, often linked to thyroid problems, where your immune system attacks the tissues around your eyes, causing inflammation and changes like bulging eyes or double vision.

What is linsitinib?

Linsitinib is a new medicine being tested. It's designed to target a specific pathway involved in TED, aiming to reduce the inflammation and symptoms.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the medicine.

How long does the study last?

The main treatment part of the study lasts 24 weeks, during which you'll take the medicine and have regular check-ups. There will also be follow-up visits after this period.

Can I leave the study if I change my mind?

Yes, you are free to stop participating in the study at any time, for any reason, without it affecting your medical care.