Ongoing Clinical Trials for Pruritus
Currently, there are 3 ongoing clinical trials investigating new treatments for persistent itching (pruritus). These studies are testing medications called dupilumab and difelikefalin in different patient groups, including adults with unexplained chronic itch, adolescents on kidney dialysis, and adults with a specific nerve-related itching condition. The trials are taking place across several European countries.
Clinical trial locations
- Germany
- Greece
- Hungary
- Italy
- Poland
- Spain
- Study on the Effectiveness and Safety of Difelikefalin for Adults with Moderate-to-Severe Itching from Notalgia Paresthetica
- Study on the Safety of Difelikefalin for Adolescents with Itching Due to Chronic Kidney Disease on Hemodialysis
- Study on the Effectiveness and Safety of Dupilumab for Adults with Chronic Itch of Unknown Cause
Study on the Effectiveness and Safety of Dupilumab for Adults with Chronic Itch of Unknown Cause
This trial is investigating dupilumab, a medication given as an injection under the skin, for adults suffering from chronic itching without a known cause. The study aims to determine whether this treatment can effectively reduce the sensation of itch in people who have been dealing with this frustrating condition for at least six months.
Who can participate: Adults between 18 and 90 years old who have experienced chronic itching for at least six months are eligible. The itch must affect at least two body areas such as the legs, arms, or trunk, and previous treatments must not have adequately controlled the symptoms. Participants need to have severe itching, with a score of 7 or higher on a scale from 0 to 10, where higher numbers mean worse itch. The itching should not be caused by known skin conditions, nerve problems, mental health issues, or medications.
Who cannot participate: People with known allergies to dupilumab or its ingredients, those with a history of severe allergic reactions called anaphylaxis, pregnant or breastfeeding women, and individuals currently participating in other clinical trials are excluded. Those who have recently used certain medications that might interfere with the study or who have specific medical conditions that could affect the results also cannot join.
What the study involves: Participants will receive dupilumab injections over a period of 12 to 24 weeks, depending on their study group. Some participants will receive a placebo for comparison. Throughout the treatment, regular monitoring will assess how well the medication reduces itching and whether any side effects occur. The study will also look at how the treatment affects quality of life.
The medication being tested: Dupilumab is a monoclonal antibody that works by blocking certain proteins in the body that cause inflammation and itching, specifically targeting the interleukin-4 and interleukin-13 pathways. It is already approved for treating other inflammatory conditions like eczema and asthma.
Study on the Safety of Difelikefalin for Adolescents with Itching Due to Chronic Kidney Disease on Hemodialysis
This trial focuses on young people aged 12 to 17 who are undergoing hemodialysis for chronic kidney disease and experiencing moderate-to-severe itching. The study aims to evaluate whether difelikefalin, given through an intravenous injection during dialysis sessions, is safe and well-tolerated by this age group.
Who can participate: Adolescents between 12 and 17 years old who have chronic kidney disease and have been on hemodialysis three times per week for at least 12 weeks can join. Participants must have recorded their itching severity for at least 4 days during a 7-day period, with an average score greater than 4.0 on the itching scale. They must also meet certain dialysis adequacy measures and weigh at least 20 kg. Young women who could become pregnant must use contraception as required by local regulations.
Who cannot participate: Patients with other skin conditions that could interfere with the study, recent infections or illnesses, those taking medications that might interact with the study treatment, anyone with a history of severe allergic reactions, pregnant or breastfeeding individuals, those who participated in another trial within the last 30 days, or anyone with conditions that doctors believe would make participation unsafe are excluded.
What the study involves: After confirming eligibility and recording itching severity for 7 days, participants will receive difelikefalin at a dose of 0.5 micrograms per kilogram of body weight during their regular dialysis sessions. Throughout the study, which continues until 2029, participants will be monitored for side effects, and blood samples may be taken to measure medication levels. The goal is to assess how safe the medication is and how the body processes it.
The medication being tested: Difelikefalin is delivered directly into the bloodstream through a vein during dialysis. It works by activating kappa opioid receptors in the body, which help reduce the sensation of itching associated with kidney disease.
Study on the Effectiveness and Safety of Difelikefalin for Adults with Moderate-to-Severe Itching from Notalgia Paresthetica
This trial is investigating difelikefalin tablets taken by mouth for adults with notalgia paresthetica, a chronic condition that causes intense itching, typically on the upper back. The study has two parts: first, testing three different doses against a placebo to find the most effective dose, and second, evaluating how well the selected dose reduces itching over an 8-week period.
Who can participate: Adults with moderate-to-severe itching caused by notalgia paresthetica that has lasted at least 6 months are eligible. Participants must show visible skin changes such as darker or lighter spots, thickened or hardened skin, or scratch marks in the middle to upper back near the shoulder blades. The itching must be severe enough to warrant treatment that affects the whole body. Women must not be pregnant or nursing during the study.
Who cannot participate: People with a history of severe allergic reactions to the study medication or similar drugs, those currently in another clinical trial, anyone with medical conditions that could interfere with results, pregnant or breastfeeding women, those with a history of drug or alcohol abuse within the past year, individuals with poorly controlled mental health disorders, those with serious infections requiring hospitalization, anyone who has had major surgery within the past month, or those unable to follow study procedures are excluded.
What the study involves: In Part A, different doses of difelikefalin are compared to a placebo to determine the most effective dose. In Part B, the selected dose is tested over 8 weeks to see how well it reduces itching. Participants take oral tablets daily, and regular assessments monitor itch intensity, changes in burning or tingling sensations, and any side effects. A follow-up period after treatment completion tracks any adverse events.
The medication being tested: Difelikefalin is taken as an oral tablet and works by activating kappa opioid receptors in the body, which help reduce the sensation of itching. It is classified as a kappa opioid receptor agonist and is still under investigation for this specific use.
Summary
These three clinical trials represent important efforts to find effective treatments for different types of persistent itching. Two of the trials focus on difelikefalin, testing it in different patient groups and using different administration methods, while one trial investigates dupilumab for unexplained chronic itch. Spain appears as a location in all three trials, making it a central hub for this research, while Germany and Poland each host two trials. The studies address itching in distinct patient populations: adults with unexplained chronic itch, adolescents with kidney disease-related itching, and adults with a specific nerve-related itching condition. Together, these trials aim to expand treatment options for people suffering from the discomfort and reduced quality of life associated with chronic itching.
