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Study of Lu AG22515 for Adults with Moderate-to-Severe Thyroid Eye Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Thyroid Eye Disease (TED), a condition often associated with Graves' disease that affects the eyes, causing symptoms like bulging eyes. The trial will investigate a treatment called Lu AG22515, which is a special type of protein designed to target and interact with specific parts of the immune system involved in TED. The treatment is given as a solution through an infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to evaluate how effective Lu AG22515 is in reducing the bulging of the eyes, known as proptosis, in patients with moderate-to-severe TED. Participants in the study will receive the treatment over a period of time, and their progress will be monitored to see how the treatment affects their eye condition. The study will also look at how the body processes the treatment and check for any side effects or immune responses.

Throughout the study, participants will have regular check-ups to measure changes in their eye condition and overall health. The trial aims to provide valuable information on the potential benefits and safety of Lu AG22515 for people living with moderate-to-severe Thyroid Eye Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the participant is confirmed to have symptoms of Thyroid Eye Disease (TED) associated with Graves' disease. These symptoms must have started less than 12 months before the baseline visit.

    The participant's eye condition is assessed using a tool called the Hertel exophthalmometer to measure eye protrusion, which must be at least 3 millimeters above normal for their race and sex.

  2. Step 2

    Baseline visit

    During the baseline visit, the participant's thyroid hormone levels are checked to ensure they are within a specific range, indicating they are either euthyroid or have mild thyroid dysfunction.

    The Clinical Activity Score (CAS) is evaluated to confirm it is 3 or higher in the most affected eye.

  3. Step 3

    Treatment administration

    The participant receives a medication called Lu AG22515, which is a fusion protein targeting a specific protein involved in TED. This medication is administered as a solution for infusion.

    The infusion schedule, dosage, and frequency are determined by the trial protocol and are designed to assess the medication's effect on reducing eye protrusion.

  4. Step 4

    Follow-up assessments

    Throughout the trial, the participant undergoes regular assessments to monitor changes in eye protrusion using the Hertel exophthalmometer.

    Additional evaluations include checking vital signs, weight, and conducting laboratory tests to ensure safety and monitor any side effects.

  5. Step 5

    End of trial evaluation

    At the end of the trial, the primary outcome is the change in eye protrusion from the baseline to week 24.

    Secondary outcomes include the analysis of the medication's presence in the body, safety assessments, and the detection of any antibodies against the medication.

Who can join the trial?

7 criteria

  • The participant must have **Graves' disease** with **Thyroid Eye Disease (TED)** symptoms. This means the person has a condition related to the thyroid gland that affects the eyes.
  • The eye symptoms must have started less than 12 months before the first visit for the study.
  • The participant must have **proptosis**, which is when the eyes bulge out more than normal. This should be at least 3 millimeters more than what is normal for their race and sex, measured with a special tool called the Hertel exophthalmometer.
  • The participant must have a **Clinical Activity Score (CAS)** of 3 or more in the most affected eye. This score helps doctors understand how active the eye disease is.
  • The participant's thyroid hormone levels should be normal or only slightly off. This means their **free thyroxin (FT4)** and/or **free triiodothyronine (FT3)** levels should not be more than 50% above or below the normal range.
  • Both male and female participants are eligible to join the study.
  • The study includes participants from vulnerable populations, which means it considers people who might need extra protection or care.

Who cannot join the trial?

5 criteria

  • Patients who do not have **active, moderate-to-severe TED**. TED stands for **Thyroid Eye Disease**, a condition affecting the eyes.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are considered part of a **vulnerable population**. This term refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Lu AG22515 is a medication being studied for its effects on Thyroid Eye Disease (TED). This trial aims to see how well Lu AG22515 works in reducing the bulging of the eyes, a common symptom of TED. The study is open-label, meaning both the researchers and participants know they are receiving Lu AG22515. The trial is focused on patients with moderate-to-severe cases of the disease, and it involves a long-term follow-up to assess the medication's effectiveness over time.

What is already known about the treatment

Lu AG22515 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating moderate-to-severe Thyroid Eye Disease (TED). It is in the investigational stage, meaning it is not yet approved for general medical use but is being evaluated for its potential benefits and safety. The main therapeutic indication for Lu AG22515 is to reduce proptosis, which is the bulging of the eye, associated with TED. At the molecular level, it works by targeting specific pathways involved in the inflammation and tissue remodeling processes that contribute to the symptoms of TED. It is classified pharmacologically as a biologic agent, which means it is derived from living organisms and designed to interact with specific components of the immune system.

Investigated diseases

Thyroid Eye Disease (TED) – Thyroid Eye Disease is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes. This leads to inflammation and swelling, causing the eyes to bulge outward, a condition known as proptosis. The disease often progresses with symptoms such as redness, irritation, and discomfort in the eyes. As it advances, individuals may experience double vision and difficulty moving the eyes. TED is commonly associated with thyroid disorders, particularly Graves' disease. The severity of symptoms can vary, with some cases being mild and others more pronounced.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508693-29-00Protocol code20453AEstimated enrolment24 patientsSponsorH. Lundbeck A/S

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