#1 Clinical Trials Search in Europe

Humanised Igg1 Monoclonal Antibody Against Interleukin 22 Receptor Subunit Alpha

A new drug called LEO 138559, which is a humanised IgG1 monoclonal antibody targeting the interleukin 22 receptor subunit alpha, is being studied in clinical trials for the treatment of moderate-to-severe atopic dermatitis. This article discusses the ongoing research, including the drug’s potential efficacy, safety, and administration methods for patients with this challenging skin condition.

Table of Contents

What is LEO 138559?

LEO 138559 is a new medication being studied for the treatment of moderate-to-severe atopic dermatitis (AD), also known as eczema[1]. It is a humanized IgG1 monoclonal antibody that targets the interleukin 22 receptor subunit alpha. In simpler terms, it’s a specially designed protein that aims to reduce inflammation in the skin by blocking a specific part of the immune system[1].

How Does LEO 138559 Work?

LEO 138559 works by targeting a specific part of the immune system involved in atopic dermatitis. It blocks the interleukin 22 receptor, which is believed to play a role in the inflammation and skin symptoms associated with AD. By doing this, the medication aims to reduce the severity of eczema symptoms and improve the overall condition of the skin[1].

Clinical Trial Details

A clinical trial is currently underway to evaluate the effectiveness and safety of LEO 138559 for adults with moderate-to-severe atopic dermatitis. This is a Phase 2b trial, which means it’s focused on finding the right dose of the medication[1].

The main goal of this trial is to compare four different dosing regimens of LEO 138559 with a placebo (a substance with no active medication) to see which works best for people with moderate-to-severe AD[1].

Who Can Participate in the Trial?

The trial is looking for adults aged 18-75 who have had atopic dermatitis for at least one year. Participants need to have moderate-to-severe AD, which is determined by several factors[1]:

  • An EASI score (a measure of eczema severity) of 16 or higher
  • A vIGA-AD score (another measure of AD severity) of 3 or higher
  • At least 10% of their body surface area affected by AD
  • A Worst Itch score of 4 or higher

Participants should also have a history of not responding well to topical treatments like corticosteroids or having side effects from these treatments[1].

Treatment Regimens

The trial is testing four different dosing regimens of LEO 138559, all given as a subcutaneous injection (an injection under the skin)[1]:

  1. Dose A given weekly for the first four weeks, then every two weeks
  2. Dose B given weekly for the first three weeks, then every two weeks
  3. Dose A given at weeks 0 and 2, then Dose C every two weeks
  4. Dose C given at weeks 0 and 2, then Dose D every two weeks

Some participants will receive a placebo instead of the active medication. The treatment period lasts for 16 weeks[1].

Potential Benefits

If successful, LEO 138559 could provide a new treatment option for people with moderate-to-severe atopic dermatitis who haven’t responded well to other treatments. The main goal is to reduce the severity of AD symptoms, which could lead to improved quality of life for patients[1].

Safety Considerations

As with any new medication, safety is a key concern. The trial will closely monitor participants for any side effects or adverse reactions. People with certain conditions, such as active infections, hepatitis B or C, HIV, or tuberculosis, are not eligible to participate in the trial for safety reasons[1].

It’s important to note that LEO 138559 is still in the testing phase, and more research is needed to fully understand its effectiveness and safety profile[1].

Aspect Details
Drug Name LEO 138559 (Humanised IgG1 Monoclonal Antibody Against Interleukin 22 Receptor Subunit Alpha)
Condition Studied Moderate-to-severe Atopic Dermatitis
Trial Phase Phase 2b
Main Objective Compare efficacy of 4 different dosage regimens with placebo
Administration Method Subcutaneous injection
Treatment Duration 14 weeks
Primary Endpoint Percent change in EASI score from baseline to Week 16
Key Inclusion Criteria Adults 18-75 years, AD diagnosis, inadequate response to previous treatments, EASI score ≥16, vIGA-AD score ≥3, BSA ≥10%
Key Exclusion Criteria Recent infections, certain prior treatments, pregnancy, hepatitis B/C, HIV, active tuberculosis

FAQ

  • What is LEO 138559 and how does it work? LEO 138559 is a humanised IgG1 monoclonal antibody that targets the interleukin 22 receptor subunit alpha. It is designed to help treat moderate-to-severe atopic dermatitis by interfering with the inflammatory processes involved in the condition.
  • What is the main goal of the clinical trial for LEO 138559? The main goal of the clinical trial is to compare the efficacy of four different dosage regimens of LEO 138559 with a placebo in subjects with moderate-to-severe atopic dermatitis.
  • How is LEO 138559 administered in the trial? LEO 138559 is administered subcutaneously (under the skin) according to different dosing schedules, ranging from weekly to every two weeks, depending on the assigned treatment group.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults aged 18-75 with moderate-to-severe atopic dermatitis who have had the condition for at least one year and have not responded adequately to previous treatments or for whom such treatments are not advisable.
  • What are some of the key measurements used in the trial? The trial uses several measurements to assess the effectiveness of the treatment, including the EASI score (Eczema Area and Severity Index), vIGA-AD score (Validated Investigator Global Assessment for Atopic Dermatitis), BSA (Body Surface Area) affected by atopic dermatitis, and the ADSD Worst Itch score.

Ongoing Clinical Trials on Humanised Igg1 Monoclonal Antibody Against Interleukin 22 Receptor Subunit Alpha

  • Study on the Effects of LEO 138559 for Adults with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    2 1
    Investigated drugs:
    Czechia France Germany Hungary Poland Romania +1

Glossary

  • Atopic Dermatitis (AD): A chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin. It is a type of eczema and is often associated with allergies and asthma.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, it's designed to target a specific receptor involved in atopic dermatitis.
  • Interleukin 22 Receptor Subunit Alpha: A part of a receptor that responds to interleukin 22, a protein involved in inflammatory processes in the body. Targeting this receptor may help reduce inflammation in atopic dermatitis.
  • Subcutaneous (SC): A method of administering medication by injecting it under the skin.
  • EASI Score: Eczema Area and Severity Index, a tool used to measure the extent and severity of atopic dermatitis.
  • vIGA-AD Score: Validated Investigator Global Assessment for Atopic Dermatitis, a scale used by healthcare professionals to assess the overall severity of atopic dermatitis.
  • BSA: Body Surface Area, a measurement of the percentage of the body affected by atopic dermatitis.
  • ADSD Worst Itch Score: A measure of the intensity of itching experienced by patients with atopic dermatitis.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Phase 2b Trial: A stage of clinical research that focuses on determining the optimal dosage of a new medication before proceeding to larger, more definitive trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-leo-138559-for-adults-with-moderate-to-severe-atopic-dermatitis/