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Tralokinumab

This article examines the use of tralokinumab, a monoclonal antibody that targets interleukin-13, in clinical trials for treating moderate to severe atopic dermatitis. We’ll explore its efficacy, safety profile, and potential as a new treatment option for this challenging skin condition based on data from multiple phase 3 trials.

Table of Contents

What is Tralokinumab?

Tralokinumab is a medication used to treat moderate to severe atopic dermatitis, which is a chronic inflammatory skin condition also known as eczema[2]. It is a type of drug called a monoclonal antibody, which means it’s a laboratory-made protein that mimics the immune system’s ability to fight off harmful antigens such as viruses[3]. Tralokinumab is also known by the brand names Adbry and Adtralza[1].

How Does Tralokinumab Work?

Tralokinumab works by targeting a specific part of the immune system that is overactive in people with atopic dermatitis. It binds to and blocks a protein called interleukin-13 (IL-13), which plays a key role in causing inflammation in the skin[4]. By reducing this inflammation, tralokinumab helps to improve the symptoms of atopic dermatitis, such as itching, redness, and skin damage.

What Conditions Does Tralokinumab Treat?

The primary condition that tralokinumab is used to treat is moderate to severe atopic dermatitis in adults and adolescents (age 12 and older) who are candidates for systemic therapy[2]. Systemic therapy means treatment that affects the entire body, not just the skin. In addition to atopic dermatitis, research is also being conducted on the use of tralokinumab for atopic hand eczema, which is a specific form of eczema that affects the hands[5].

How is Tralokinumab Administered?

Tralokinumab is given as a subcutaneous injection, which means it’s injected under the skin. The typical dosing schedule is as follows:

  • Initial dose: 600 mg (given as four 150 mg injections) on the first day of treatment
  • Maintenance dose: 300 mg every two weeks

Some studies are also looking at different dosing schedules, such as 300 mg every four weeks after the initial treatment period[4]. In some cases, patients may be able to self-administer the medication at home after proper training by healthcare professionals[6].

How Effective is Tralokinumab?

Clinical trials have shown promising results for tralokinumab in treating moderate to severe atopic dermatitis. The effectiveness of the medication is typically measured using several scales:

  • Investigator’s Global Assessment (IGA): This is a tool used by doctors to rate the severity of atopic dermatitis on a scale from 0 (clear skin) to 4 (severe disease)[3].
  • Eczema Area and Severity Index (EASI): This measures both the extent and severity of atopic dermatitis[3].
  • Pruritus Numeric Rating Scale (NRS): This measures the severity of itching[3].

In clinical trials, a significant number of patients treated with tralokinumab showed improvements in these measures compared to those receiving a placebo. For example, more patients achieved clear or almost clear skin (IGA score of 0 or 1) and had at least a 75% improvement in their EASI score after 16 weeks of treatment[6].

Is Tralokinumab Safe?

Like all medications, tralokinumab can cause side effects. The most common side effects reported in clinical trials include:

  • Upper respiratory tract infections
  • Injection site reactions (redness, swelling, or pain at the injection site)
  • Eye and eyelid inflammation

Most side effects were mild to moderate in severity. However, as with any medication, there is a potential for more serious side effects. Patients should discuss the potential risks and benefits with their healthcare provider[3].

It’s important to note that the long-term safety of tralokinumab is still being studied. There are ongoing trials looking at the safety and effectiveness of tralokinumab over longer periods, up to 52 weeks and beyond[7].

Ongoing Research on Tralokinumab

Research on tralokinumab is ongoing, with several clinical trials currently in progress. These studies are looking at various aspects of the medication, including:

  • Long-term safety and efficacy[7]
  • Use in combination with topical corticosteroids[3]
  • Effectiveness in treating atopic hand eczema[5]
  • Use in adolescents and children[8]
  • Effects on skin barrier function[9]

These ongoing studies will help to further our understanding of tralokinumab and potentially expand its use to treat more patients with atopic dermatitis and related conditions.

Aspect Details
Drug Name Tralokinumab (also known as Adbry, Adtralza)
Drug Type Human recombinant monoclonal antibody (IgG4 subclass)
Target Interleukin-13 (IL-13)
Administration Subcutaneous injection
Dosing Initial loading dose (e.g., 600mg) followed by maintenance doses (e.g., 300mg every 2 or 4 weeks)
Primary Outcomes IGA score of 0/1, EASI-75 improvement
Secondary Outcomes Reduction in pruritus, improvement in SCORAD and DLQI scores
Safety Profile Generally well-tolerated; common side effects monitored
Study Populations Adults, adolescents (12-17 years), children (6-11 years) with moderate-to-severe atopic dermatitis
Trial Durations 16 to 52 weeks, with some long-term extension studies

FAQ

  • What is tralokinumab? Tralokinumab is a human recombinant monoclonal antibody that specifically binds to interleukin-13 (IL-13), blocking its interaction with IL-13 receptors. It is being studied as a treatment for moderate to severe atopic dermatitis.
  • How is tralokinumab administered? Tralokinumab is administered as a subcutaneous (under the skin) injection. In clinical trials, it is typically given as an initial loading dose followed by regular injections every 2 or 4 weeks.
  • What are the main outcomes measured in tralokinumab clinical trials? The main outcomes include improvements in skin clearance (measured by IGA scores), reduction in eczema severity (measured by EASI scores), reduction in itch intensity, and improvements in quality of life measures.
  • Is tralokinumab safe for long-term use? Clinical trials are evaluating the long-term safety of tralokinumab. So far, studies have monitored its safety for up to 52 weeks, with ongoing trials looking at even longer periods. The most common side effects reported are generally mild to moderate.
  • Can tralokinumab be used in children with atopic dermatitis? While initial trials focused on adults, there are ongoing studies evaluating tralokinumab in adolescents (ages 12-17) and children (ages 6-11) with moderate to severe atopic dermatitis to determine its safety and efficacy in younger populations.

Ongoing Clinical Trials on Tralokinumab

  • Study on Tralokinumab and Topical Corticosteroids for Children and Infants with Moderate-to-Severe Atopic Dermatitis

    Recruiting

    4 1 1
    Investigated drugs:
    Belgium Croatia Czechia Denmark Germany Ireland +6

  • Study on Atopic Dermatitis Treatment with Baricitinib, Tralokinumab, Abrocitinib, Upadacitinib, and Dupilumab for Patients Needing Second-Line Systemic Therapy

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Tralokinumab for Children Aged 6-11 with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Czechia France The Netherlands Spain

  • Study on Tralokinumab for Moderate-to-Severe Atopic Hand Eczema in Patients Needing Systemic Therapy

    Not recruiting

    3 1 1
    Investigated drugs:
    Belgium Czechia France Germany The Netherlands Poland +3

Glossary

  • Atopic Dermatitis (AD): A chronic inflammatory skin condition characterized by itchy, red, swollen, and cracked skin. It is also known as eczema.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, tralokinumab is a monoclonal antibody that targets IL-13.
  • Interleukin-13 (IL-13): A protein involved in the immune response that plays a role in the development of atopic dermatitis.
  • Subcutaneous (SC) Injection: An injection given into the fatty tissue just beneath the skin.
  • Investigator's Global Assessment (IGA): A tool used to evaluate the overall severity of atopic dermatitis, typically on a scale from 0 (clear) to 4 (severe).
  • Eczema Area and Severity Index (EASI): A tool used to measure the extent and severity of atopic dermatitis. Scores range from 0 to 72, with higher scores indicating more severe disease.
  • Scoring Atopic Dermatitis (SCORAD): Another tool used to assess the severity of atopic dermatitis, considering extent, intensity, and subjective symptoms. Scores range from 0 to 103.
  • Dermatology Life Quality Index (DLQI): A questionnaire that measures the impact of skin conditions on a person's quality of life.
  • Pruritus: The medical term for itching.
  • Numeric Rating Scale (NRS): A scale used to measure the intensity of symptoms, such as itch, typically ranging from 0 to 10.
  • Anti-drug Antibodies (ADA): Antibodies produced by the body against a medication, which can potentially reduce its effectiveness.
  • Topical Corticosteroids (TCS): Steroid creams or ointments applied directly to the skin to reduce inflammation and itching.

References

  1. https://clinicaltrials.gov/study/NCT05938478
  2. https://clinicaltrials.gov/study/NCT03526861
  3. https://clinicaltrials.gov/study/NCT03363854
  4. https://clinicaltrials.gov/study/NCT03160885
  5. https://clinicaltrials.gov/study/NCT05958407
  6. https://clinicaltrials.gov/study/NCT03131648
  7. https://clinicaltrials.gov/study/NCT03587805
  8. https://clinicaltrials.gov/study/NCT05388760
  9. https://clinicaltrials.gov/study/NCT04556461