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Human (Scfv)2-Fab Fusion Protein Against Cd40L

A new clinical trial is underway to evaluate the effectiveness of Lu AG22515, a Human (Scfv)2-Fab Fusion Protein Against CD40L, in treating moderate-to-severe Thyroid Eye Disease (TED). This open-label, single-group study aims to assess the drug’s impact on reducing proptosis, a common symptom of TED, as well as its safety and tolerability in adult patients. The trial represents an important step in exploring potential new therapies for this challenging autoimmune condition.

Table of Contents

What is Lu AG22515?

Lu AG22515 is a new medication being studied for the treatment of moderate-to-severe Thyroid Eye Disease (TED). It is classified as a HUMAN (SCFV)2-FAB FUSION PROTEIN AGAINST CD40L, which is a type of engineered protein designed to target specific molecules in the body[1]. This medication is currently in the experimental stage and is being tested in clinical trials to evaluate its effectiveness and safety.

Thyroid Eye Disease: An Overview

Thyroid Eye Disease, also known as TED, is a condition associated with Graves’ disease, an autoimmune disorder affecting the thyroid gland. TED causes inflammation and swelling of the tissues around the eyes, leading to symptoms such as bulging eyes (proptosis), eye redness, and in severe cases, vision problems[1].

How Lu AG22515 Works

Lu AG22515 is designed to target a specific molecule called CD40L, which plays a role in the immune system. By interfering with CD40L, the medication aims to reduce the inflammation and swelling associated with Thyroid Eye Disease. This could potentially lead to improvements in symptoms, particularly the bulging of the eyes (proptosis)[1].

Clinical Trial Details

A clinical trial is currently underway to study Lu AG22515. Here are some key details about the trial:

  • Trial Type: This is an interventional, open-label, single-group, long-term follow-up trial[1].
  • Phase: It is classified as a therapeutic exploratory phase IB trial[1].
  • Main Objective: The primary goal is to evaluate how effective Lu AG22515 is in reducing proptosis (eye bulging) in patients with TED[1].
  • Duration: The trial will assess changes in proptosis from the start of treatment up to 24 weeks[1].

Eligibility Criteria

To participate in this trial, patients must meet certain criteria. Some key inclusion criteria are:

  • Having Graves’ disease associated Thyroid Eye Disease with symptoms starting less than 12 months before the trial[1].
  • Showing significant eye bulging (proptosis) of at least 3 millimeters above normal[1].
  • Having a Clinical Activity Score (CAS) of 3 or higher, which indicates active inflammation[1].

There are also several exclusion criteria, such as:

  • Having severe vision problems due to optic nerve involvement[1].
  • Previous orbital radiation or surgery for TED[1].
  • Certain medications or recent vaccinations[1].

Potential Benefits

If successful, Lu AG22515 could offer several benefits for patients with moderate-to-severe Thyroid Eye Disease:

  • Reduction in eye bulging (proptosis)[1].
  • Potential improvement in other TED symptoms.
  • A new treatment option for patients who haven’t responded well to other therapies.

Safety Considerations

As with any new medication, safety is a crucial aspect of the clinical trial. The researchers will be closely monitoring:

  • Any side effects that occur during treatment (known as Treatment-Emergent Adverse Events or TEAEs)[1].
  • Changes in laboratory test results, vital signs, weight, and heart activity (ECG)[1].
  • The body’s immune response to the medication (immunogenicity)[1].

Future Prospects

This clinical trial is an important step in developing Lu AG22515 as a potential treatment for Thyroid Eye Disease. If the results are positive, it could lead to further studies and potentially a new treatment option for patients with this condition. The company conducting the trial, Lundbeck, has committed to sharing the data from this clinical trial once the product is approved in Europe and/or the United States[1].

Aspect Details
Trial Name 2023-508693-29-00
Drug Name Lu AG22515 (Human (Scfv)2-Fab Fusion Protein Against CD40L)
Condition Moderate-to-severe Thyroid Eye Disease (TED)
Trial Type Interventional, open-label, single-group, long-term follow-up
Primary Endpoint Change in proptosis from Baseline to Week 24 in the trial eye
Key Inclusion Criteria TED symptoms onset <12 months, proptosis ≥3 mm above normal, Clinical Activity Score ≥3
Key Exclusion Criteria Decreased visual acuity due to optic neuropathy, previous orbital irradiation or surgery for TED
Secondary Endpoints Pharmacokinetics, safety, immunogenicity

FAQ

  • What is Thyroid Eye Disease (TED)? Thyroid Eye Disease is an autoimmune condition associated with Graves' disease that affects the eyes. It causes inflammation and swelling of the eye muscles and fatty tissue behind the eye, leading to symptoms such as bulging eyes (proptosis), eye redness, and vision changes.
  • What is Lu AG22515? Lu AG22515 is an investigational drug classified as a Human (Scfv)2-Fab Fusion Protein Against CD40L. It is being studied as a potential treatment for moderate-to-severe Thyroid Eye Disease.
  • What is the main goal of this clinical trial? The main objective of this trial is to evaluate the efficacy of Lu AG22515 in reducing proptosis (eye bulging) in patients with moderate-to-severe Thyroid Eye Disease.
  • Who can participate in this clinical trial? Participants must have Graves' disease-associated Thyroid Eye Disease with symptoms onset within 12 months, proptosis of 3mm or more above normal, and a Clinical Activity Score of 3 or higher in the most severe eye. They must also be euthyroid or have mild thyroid dysfunction.
  • How long does the trial last? The trial includes a 24-week treatment period, during which the primary endpoint (change in proptosis) will be measured. However, the total duration of the trial may be longer as it is described as a long-term follow-up study.

Ongoing Clinical Trials on Human (Scfv)2-Fab Fusion Protein Against Cd40L

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

    Not recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Germany Poland Spain

Glossary

  • Proptosis: A condition where the eyes bulge or protrude from their normal position in the eye sockets. In Thyroid Eye Disease, this is often caused by inflammation and swelling of the tissues behind the eye.
  • Clinical Activity Score (CAS): A scoring system used to assess the activity of Thyroid Eye Disease. It takes into account various symptoms and signs of inflammation in the eyes.
  • Euthyroid: A state where thyroid hormone levels are within the normal range, indicating normal thyroid function.
  • Hertel exophthalmometer: A medical instrument used to measure the degree of protrusion of the eye (proptosis) by determining the distance between the lateral orbital rim and the apex of the cornea.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and the relationship between drug concentration and effect.
  • Anti-drug antibodies (ADAs): Antibodies produced by the immune system in response to a therapeutic drug, which can potentially affect the drug's efficacy or safety.
  • Treatment-emergent adverse events (TEAEs): Any unfavorable and unintended sign, symptom, or disease that appears or worsens after starting a medical treatment in a clinical trial.

References

  1. http://clinicaltrials.eu/trial/study-of-lu-ag22515-for-adults-with-moderate-to-severe-thyroid-eye-disease/