Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Proof-of-Concept, Randomized, Double-Masked, Placebo-Controlled Study to Determine the Efficacy and Safety of LASN01 in Patients with Thyroid Eye Disease

This research study is investigating a new medication, LASN01, for individuals living with Thyroid Eye Disease (TED). TED is an autoimmune condition that affects the eyes, often causing them to bulge. This study is in an early stage (Phase 2), meaning it's one of the first times this specific drug is being tested in a larger group of people with the condition. The main goals are to find out if LASN01 can help reduce eye bulging and to carefully check for any side effects it might cause. To do this, some participants will receive LASN01, while others will get a placebo (a dummy treatment, like a saline solution), but neither the participants nor the researchers will know who is getting what. This helps ensure the results are as fair and accurate as possible. The study hopes to gather important information about the potential benefits and safety of LASN01 for TED patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Lassen Therapeutics 1 Inc.

Enrolment target

Start

01 Mar 2024

Thyroid Eye Disease

What is this study about?

This clinical study is looking into a new treatment called LASN01 for a condition called Thyroid Eye Disease (TED). TED is an autoimmune condition, which means the body's immune system mistakenly attacks healthy tissues, in this case, the tissues around the eyes. This can lead to various symptoms, including eye bulging (proptosis), double vision, dry eyes, and discomfort. The main aim of this research is to see if LASN01 can help to improve these symptoms, especially reducing the bulging of the eyes.

The study is in 'Phase 2'. This means researchers are giving LASN01 to a bigger group of people with TED for the first time. They want to check two main things: first, if the medicine actually works (this is called 'efficacy'), and second, if it's safe and well-tolerated by patients. Comparing LASN01 to a 'placebo' (a non-active solution that looks the same) helps the team understand if any improvements are truly due to the new medicine or something else.

Researchers will carefully measure changes in eye bulging using a special tool and look at other signs of TED, like how often participants experience double vision or have dry eyes. They will also keep a close eye on any side effects, track general health markers like blood pressure, and take blood samples to understand how LASN01 moves through the body. All this information is vital to decide if LASN01 could be a promising new treatment option for people with Thyroid Eye Disease.

Key takeaways

This study is testing a new drug, LASN01, for Thyroid Eye Disease.
It aims to see if LASN01 can reduce eye bulging and is safe to use.
Participants will receive either LASN01 or a non-active placebo.
It's a 'Phase 2' study, an important step in developing new treatments.
Regular health checks and eye measurements will be part of the study.
Your participation could help advance treatments for TED.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with Thyroid Eye Disease.

There might be other reasons why someone can't join, such as other medical conditions you have, or specific medications you are currently taking. These specific details would be discussed with you by the study doctor to make sure the study is a safe and suitable option for you.

It's important to remember that not everyone with Thyroid Eye Disease will be able to take part. The research team needs to make sure the participants are a good fit for this particular study's goals and safety requirements.

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.

Are you 18 years old or older?
Have you been diagnosed with Thyroid Eye Disease?
Are you able to attend regular clinic visits?
Are you comfortable with the possibility of receiving a placebo?
Are you willing to report any health changes or side effects?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would have regular visits to the clinic over a period of time. During these visits, you will have various health checks, including physical examinations, blood tests, and possibly ECGs (heart tracings). Your eye symptoms, especially eye bulging and other TED-related signs, will be carefully measured and monitored.

You will receive either the study drug, LASN01, or a placebo (a dummy treatment that looks just like the real medicine). This will likely be given as an infusion, meaning it's put directly into your bloodstream through a drip. Neither you nor your study doctor will know which one you are getting, which helps ensure the study results are fair.

Throughout the study, you'll need to report any new symptoms or side effects you experience. There will also be follow-up visits after you finish receiving the medication to ensure your health is stable. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial comes with potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment, LASN01, that could help improve your Thyroid Eye Disease symptoms, especially eye bulging, before it's widely available. You would also be contributing valuable information that could help others with TED in the future. However, there's also a chance you might receive the placebo, or that LASN01 may not work for you, or could cause side effects. Possible risks include discomfort from blood draws or infusions, and potential side effects from the medication, which would be explained in full. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Germany

Common questions

What is Thyroid Eye Disease?

Thyroid Eye Disease (TED) is an autoimmune condition where your body's immune system mistakenly attacks the tissues around your eyes, often causing them to bulge or become inflamed.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare how well the new medicine works.

Why is it important that neither I nor the doctor know what I'm getting?

This is called 'double-masked' and it means the results of the study are less likely to be influenced by anyone's expectations, making them more reliable.

Will my regular medical care be affected if I join?

No, your decision to join or not join will not affect your usual medical care or relationship with your doctor.

What does 'Phase 2' mean for a study?

Phase 2 means the new medicine is being tested in a larger group of people for the first time to see if it works and to check for common side effects, after initial small-scale safety tests.