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Bempikibart

A clinical trial is underway to assess the safety and efficacy of Bempikibart, also known as ADX-914, for patients with moderate to severe atopic dermatitis. This Phase 2a study aims to determine the optimal dosage and evaluate the drug’s effectiveness compared to a placebo. The trial involves adult patients who have not responded adequately to previous treatments and will help researchers understand the potential of Bempikibart in managing this chronic skin condition.

Table of Contents

What is BEMPIKIBART?

BEMPIKIBART, also known by its research name ADX-914, is a new medication being studied for the treatment of moderate to severe atopic dermatitis[1]. It is a type of drug called a monoclonal antibody, which is a laboratory-made protein that mimics the immune system’s ability to fight off harmful antigens such as viruses. Specifically, BEMPIKIBART is a human IgG1 kappa monoclonal antibody that targets a protein in your body called the interleukin 7 receptor[1].

How Does BEMPIKIBART Work?

BEMPIKIBART works by targeting and blocking the interleukin 7 receptor. This receptor plays a role in the immune system’s response, which can contribute to inflammation in conditions like atopic dermatitis. By blocking this receptor, BEMPIKIBART may help reduce inflammation and alleviate symptoms of atopic dermatitis[1].

What Conditions Does BEMPIKIBART Treat?

BEMPIKIBART is being studied for the treatment of moderate to severe atopic dermatitis[1]. Atopic dermatitis, also known as eczema, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It can cause significant discomfort and impact quality of life. The “moderate to severe” designation indicates that the condition is significantly affecting a person’s daily life and may not have responded well to other treatments.

Clinical Trial Details

BEMPIKIBART is currently being studied in a Phase 2a clinical trial. This type of trial aims to assess the drug’s effectiveness and safety in a larger group of patients[1]. The study is designed as follows:

  • It is a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either BEMPIKIBART or a placebo, and neither the participants nor the researchers know who is receiving which treatment.
  • The study aims to evaluate the safety and effectiveness of BEMPIKIBART in people with moderate to severe atopic dermatitis.
  • Participants must be at least 18 years old and have had atopic dermatitis for at least 3 years.
  • The study will measure improvements in skin symptoms using standardized scales such as the Eczema Area and Severity Index (EASI) and the Scoring Atopic Dermatitis (SCORAD) score[1].

Dosage and Administration

In the clinical trial, BEMPIKIBART is being administered as follows:

  • It is given as a subcutaneous injection, which means it is injected just under the skin.
  • The dose being studied is 200 mg, given every 2 weeks for a total of 7 doses over 12 weeks[1].
  • The total treatment period is 12 weeks, followed by a 12-week follow-up period.

Potential Benefits

While the full results of the clinical trial are not yet known, researchers hope that BEMPIKIBART may offer the following benefits for people with moderate to severe atopic dermatitis:

  • Reduction in skin inflammation and itching
  • Improvement in the appearance of affected skin areas
  • Better control of atopic dermatitis symptoms
  • Improved quality of life for people living with this condition

Safety Considerations

As with any new medication, safety is a primary concern in the clinical trial of BEMPIKIBART. The researchers are carefully monitoring for any side effects or adverse reactions. Some important safety considerations include:

  • The study excludes people with recent or current serious infections, as the medication may affect the immune system[1].
  • Participants cannot have received a live vaccine within 12 weeks before starting the study or expect to receive one during the study.
  • The study is not open to pregnant or breastfeeding women, or women planning to become pregnant.
  • Participants are monitored through various means, including physical examinations, laboratory tests, and electrocardiograms (ECGs)[1].

It’s important to note that BEMPIKIBART is still in the research phase, and more information about its effectiveness and safety will become available as the clinical trial progresses. If you have atopic dermatitis and are interested in new treatment options, it’s best to discuss this with your healthcare provider, who can provide the most up-to-date information and advice based on your individual situation.

Aspect Details
Drug Name Bempikibart (ADX-914)
Condition Moderate to Severe Atopic Dermatitis
Trial Phase Phase 2a
Administration Subcutaneous injection, 200mg every 2 weeks
Duration 12 weeks treatment, 12 weeks follow-up
Primary Objectives Identify recommended dose, evaluate efficacy vs placebo
Key Measurements EASI score, SCORAD score, vIGA-AD score
Safety Evaluation Adverse events, laboratory tests, physical exams, vital signs, ECG

FAQ

  • What is Bempikibart (ADX-914)? Bempikibart, also known as ADX-914, is a new drug being tested for the treatment of moderate to severe atopic dermatitis. It is a human monoclonal antibody that targets the interleukin 7 receptor, which may play a role in the immune response associated with atopic dermatitis.
  • Who can participate in this clinical trial? The trial is open to adults (18 years and older) with chronic atopic dermatitis lasting at least 3 years. Participants must have moderate to severe disease activity and a history of inadequate response to previous treatments such as topical steroids, systemic medications, or approved biologics.
  • How is the drug administered in the trial? Bempikibart is administered as a subcutaneous injection (an injection under the skin) every 2 weeks for a total of 7 doses over a 12-week treatment period.
  • What are the main goals of this clinical trial? The main objectives of the trial are to identify the recommended dose of Bempikibart, evaluate its efficacy compared to a placebo, and assess its safety and tolerability in patients with atopic dermatitis.
  • How long does the clinical trial last? The trial consists of three periods: a screening period of up to 4 weeks, a 12-week treatment period, and a 12-week follow-up period, for a total duration of approximately 28 weeks.

Ongoing Clinical Trials on Bempikibart

  • Study on the Safety and Effectiveness of ADX-914 for Patients with Moderate to Severe Atopic Dermatitis

    Not recruiting

    2 1
    Investigated drugs:
    Poland

Glossary

  • Atopic Dermatitis: A chronic, inflammatory skin condition characterized by itchy, red, and dry skin. It is also known as eczema.
  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to specific targets in the body, such as on the surface of cells. In this case, Bempikibart is a monoclonal antibody that targets the interleukin 7 receptor.
  • Subcutaneous Injection: A method of administering medication by injecting it into the layer of tissue just beneath the skin.
  • Placebo: A substance that looks like the real medication but contains no active ingredients. It is used as a control in clinical trials to compare the effects of the actual drug.
  • EASI Score: Eczema Area and Severity Index, a tool used to measure the extent and severity of atopic dermatitis.
  • SCORAD: Scoring Atopic Dermatitis, another method used to assess the severity of atopic dermatitis.
  • vIGA-AD: Validated Investigator Global Assessment for Atopic Dermatitis, a scale used by healthcare professionals to evaluate the overall severity of atopic dermatitis.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-adx-914-for-patients-with-moderate-to-severe-atopic-dermatitis/