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Study on the Effectiveness and Safety of Dupilumab for Adults with Chronic Itch of Unknown Cause

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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 condition known as chronic pruritus of unknown origin (CPUO), which is a persistent itch without a known cause. The trial aims to evaluate the effectiveness and safety of a medication called dupilumab, which is administered as a solution for injection. The study will also involve a comparison with a placebo to assess the true effects of the medication.

The purpose of the study is to determine how well dupilumab can reduce the sensation of itch in adults suffering from CPUO. Participants in the study will receive either the medication or a placebo and will be monitored over a period of time to observe any changes in their symptoms. The study will also include the use of other medications like fexofenadine and loratadine, which are commonly used antihistamines, to see how they interact with the treatment.

Throughout the study, participants will be asked to report on their itch levels and any changes they experience. The trial will last for several weeks, with regular check-ins to track progress and ensure safety. The ultimate goal is to find a more effective way to manage and relieve the symptoms of CPUO, improving the quality of life for those affected by this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and the presence of chronic itch for at least six months.

    The itch must affect certain body areas and have been inadequately controlled by previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of the itch using a numerical rating scale.

    Participants must have a severe itch score to proceed.

  3. Step 3

    Treatment phase

    Participants receive dupilumab as a solution for injection under the skin.

    The treatment aims to reduce the severity of the itch over a period of 12 to 24 weeks, depending on the study group.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    Participants' itch severity and quality of life are evaluated at various intervals.

  5. Step 5

    Completion of the study

    The study concludes after the designated treatment period, with a final assessment of itch severity and overall health.

    Participants' experiences and outcomes contribute to the understanding of the treatment's effectiveness.

Who can join the trial?

9 criteria

  • Participant must be between 18 and 90 years old at the time of signing the consent form.
  • Participants must have had **chronic pruritus** (long-lasting itch) for at least 6 months before the screening visit.
  • The chronic pruritus should be of unknown origin, meaning the cause is not known, and it is not due to skin or body conditions, nerve-related or mental health issues, or medications.
  • The chronic pruritus must affect at least two of these body areas: legs, arms, or trunk (the main part of the body).
  • Participants should have a history of not being able to control the chronic pruritus with previous treatments.
  • Participants should be receiving the best possible treatment for any other conditions they have that could affect the pruritus, like diabetes or iron deficiency.
  • Participants must have a history of severe itch and a worst itch score of 7 or higher at screening on the **WI-NRS** (a scale from 0 to 10, where a higher score means worse itch) and a **Patient Global Impression of Severity (PGIS)** of pruritus marked as "severe" at screening.
  • Participants must have an average worst itch score of 7 or higher in the 7 days before the run-in visit and in the 7 days before Day 1 on the WI-NRS.
  • Participants must have a PGIS of pruritus marked as "severe" on Day 1.

Who cannot join the trial?

7 criteria

  • Participants who have a known allergy to the study medication or its ingredients cannot join the study.
  • Individuals with a history of severe allergic reactions, known as **anaphylaxis**, are not eligible. **Anaphylaxis** is a serious and rapid allergic reaction that can be life-threatening.
  • People who are currently participating in another clinical trial are not allowed to take part in this study.
  • Participants who have used certain medications that might interfere with the study results will be excluded.
  • Individuals with certain medical conditions that could affect the study outcomes are not eligible.
  • Pregnant or breastfeeding women cannot participate in the study.
  • Participants who are unable to comply with the study procedures or follow-up visits will be excluded.
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Investigated drugs

Dupilumab is a medication being studied for its ability to reduce itching in adults with chronic pruritus of unknown origin. It works by blocking certain proteins in the body that can cause inflammation and itching. This trial aims to see how effective and safe dupilumab is for people who experience persistent itching without a known cause.

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials for its effectiveness in treating chronic pruritus of unknown origin, a condition characterized by persistent itching. The medication works by blocking certain proteins in the body that contribute to inflammation, specifically targeting the interleukin-4 and interleukin-13 pathways. Dupilumab is classified as a monoclonal antibody and is already approved for use in other inflammatory conditions, such as eczema and asthma.

Investigated diseases

Pruritus – Pruritus, commonly known as itching, is a sensation that provokes the desire to scratch. It can be a symptom of various conditions, including skin disorders, systemic diseases, or allergic reactions. The sensation is often caused by irritation or inflammation of the skin, leading to discomfort. Pruritus can be localized to a specific area or generalized across the body. Over time, persistent scratching can lead to skin damage, such as redness, swelling, or even infection. The intensity and duration of pruritus can vary, affecting daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508879-36-00Protocol codeEFC16973Estimated enrolment292 patientsSponsorSanofi-Aventis Recherche & Developpement

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