Not recruitingRare disease

Study on the Effects of Barzolvolimab for Patients with Prurigo Nodularis

Fast replyInvestigationalNo 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 a skin condition called Prurigo Nodularis, which is characterized by itchy, hard bumps on the skin. The study will evaluate a treatment called Barzolvolimab, also known by its code name CDX-0159. Barzolvolimab is a type of medication known as a monoclonal antibody, which is a protein designed to target specific parts of the immune system. In this study, Barzolvolimab will be compared to a placebo to see how effective it is in reducing itchiness in patients with Prurigo Nodularis.

The purpose of the study is to assess the effectiveness and safety of Barzolvolimab in treating the itch associated with Prurigo Nodularis. Participants in the study will receive either Barzolvolimab or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are unbiased. The study will last for several weeks, during which participants will be monitored for changes in their symptoms and any side effects they may experience.

Throughout the study, participants will be asked to keep a daily diary to record their itch levels and any other symptoms. The main goal is to see if there is a significant improvement in the itchiness experienced by participants taking Barzolvolimab compared to those taking the placebo. The study will also look at other factors, such as the overall condition of the skin and any changes in quality of life. Participants will have regular check-ups with the study team to ensure their safety and to track their progress.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Visit and Baseline Assessment
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A baseline assessment of itch severity is performed using a numeric rating scale. This helps to establish a starting point for measuring changes during the study.
Step 2
Randomization and First Dose
Participants are randomly assigned to receive either the study medication, barzolvolimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The first dose is administered subcutaneously, which means it is injected under the skin. The study medication is a humanized immunoglobulin G1 kappa monoclonal antibody.
Step 3
Regular Dosing and Monitoring
Participants receive regular doses of the assigned treatment. The frequency and duration of these doses are determined by the study protocol.
Throughout the study, participants are monitored for any changes in their condition and for any potential side effects. This includes regular check-ups and assessments of itch severity.
Step 4
Midpoint Evaluation
At Week 12, a primary evaluation is conducted to assess the effectiveness of the treatment. This involves measuring the improvement in itch severity from the baseline.
Additional assessments may be conducted to evaluate the overall condition of the skin and any changes in the number of nodules.
Step 5
Continuation and Final Evaluation
Participants continue to receive their assigned treatment until the end of the study period, which may last up to 24 weeks.
A final evaluation is conducted to assess the long-term effects of the treatment. This includes a comprehensive review of itch severity, skin condition, and any side effects experienced during the study.
Step 6
Post-Study Follow-Up
After completing the study, participants may be asked to attend follow-up visits to monitor their condition and ensure any side effects are addressed.
These visits help to gather additional data on the long-term safety and effectiveness of the treatment.

Who can join the trial?

16 criteria

Must have read, understood, and signed a written consent form to participate in the study. This means you agree to join the study after it has been explained to you.
Must have a kidney function test result of at least 45 mL/min/1.73 m². This test checks how well your kidneys are working.
Females who can have children must agree to use very effective birth control methods during the study and for at least 150 days after the study treatment. These methods include certain hormonal contraceptives, an intrauterine device (IUD), or having had surgery to prevent pregnancy.
Females who cannot have children, either due to surgery or menopause (no periods for at least 1 year), can participate.
Male participants must agree to use barrier methods of birth control, like condoms, with female partners who can have children during the study and for at least 150 days after the study treatment. Their female partners must also use very effective birth control methods during this time.
Male participants who have had a successful vasectomy (a surgery to prevent having children) do not need to use additional birth control methods.
Male participants must agree not to donate sperm during the study and for at least 150 days after the study treatment.
Must be willing and able to follow all study requirements and procedures, including completing a daily study diary for at least 5 out of 7 days before starting the study.
Must be 18 years of age or older.
Must have been diagnosed with Prurigo Nodularis (PN) by a skin doctor at least 3 months before the study starts.
Must have at least 20 PN nodules (bumps) on both arms, both legs, or both sides of the body at the start of the study.
Must have severe itching, with a score of 7 or higher on a scale measuring itch intensity, during the 7 days before starting the study. You need to have recorded this in a daily diary for at least 5 of those 7 days.
Must have a history of not responding well to prescription skin medications or being unable to use them for safety reasons. This means the medications did not clear or almost clear the skin or reduce the disease activity of PN lesions.
Must be willing to use a skin moisturizer once or twice a day during the study. You should have used a stable amount of moisturizer for at least 5 out of the 7 days before starting the study.
Must have normal levels of hemoglobin, white blood cells, neutrophils, and platelets in a blood test.
Must have liver function test results within normal limits, except for a condition called Gilbert's Syndrome, which is allowed.

Who cannot join the trial?

8 criteria

Participants who have a medical condition other than Prurigo nodularis that could interfere with the study.
Participants who are not within the specified age range for the study.
Participants who are part of a vulnerable population that the study cannot accommodate.
Participants who are unable to comply with the study procedures or follow-up requirements.
Participants who have used certain medications or treatments that could affect the study results.
Participants who have a history of allergic reactions to the study medication or similar drugs.
Participants who are pregnant or breastfeeding, as the study may not be safe for them.
Participants who have participated in another clinical trial recently, which could interfere with this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Futuremeds Sp. z o.o.
Wroclaw, Poland
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

Barzolvolimab is a medication being studied for its potential to reduce itching in patients with Prurigo Nodularis, a skin condition characterized by itchy nodules. The trial aims to determine how effective and safe Barzolvolimab is in improving the itch response in these patients.

Barzolvolimab

What is already known about the treatment

Barzolvolimab – This medication is administered through an injection. It is currently being studied in clinical trials for its effectiveness and safety in treating prurigo nodularis, a skin condition characterized by itchy nodules. Barzolvolimab works by targeting specific molecules in the immune system to reduce inflammation and itchiness. It is classified as a monoclonal antibody, which means it is designed to bind to specific proteins in the body to help manage symptoms.

Investigated diseases

Prurigo Nodularis – Prurigo nodularis is a chronic skin condition characterized by the presence of hard, itchy nodules on the skin. These nodules are often intensely itchy, leading to frequent scratching, which can worsen the condition. The exact cause of prurigo nodularis is not well understood, but it is believed to be related to an overactive immune response. The nodules can vary in size and are typically found on the arms, legs, and other areas of the body. Over time, the skin around the nodules may become thickened and discolored due to persistent scratching. The condition can significantly impact the quality of life due to the severe itch and discomfort it causes.