Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Assessing the efficacy and safety of nemolizumab in patients aged 12 years or older with dystrophic epidermolysis bullosa

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on dystrophic epidermolysis bullosa, a rare disorder that makes the skin very fragile, causing blisters and tears from minor friction. The medication being tested is Nemolizumab, which is given as an injection under the skin (subcutaneous). The purpose of the study is to determine whether this drug can reduce pruritus (itching) after four weeks of treatment in patients aged 12 years and older.

Participants receive a series of injections during the first month and are then followed for up to six months. Itching is measured with the Peak Pruritus Numerical Rating Scale, a simple 0‑10 score where 0 means no itch and 10 means the worst itch imaginable. Pain is tracked with a similar 0‑10 rating called the Pain Numeric Rating Scale, and overall skin‑related quality of life is assessed using the Dermatology Life Quality Index. Additional checks include measuring how far the mouth can open, joint movement in the elbow and knee, finger extension, and swallowing ability to see if skin changes affect these functions. All side effects, such as mild allergic reactions or headaches, are recorded throughout the study to evaluate safety.

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

    Baseline Visit and Initial Assessments

    You will attend the first study visit after joining the trial. During this visit, the research team will confirm that you meet the study criteria and will record your medical history.

    You will complete questionnaires that measure itch intensity using the Peak Pruritus Numerical Rating Scale (PP‑NRS), pain using the Pain Numeric Rating Scale (PNRS), and quality of life using the Dermatology Life Quality Index (DLQI).

    A photograph of the most affected leg will be taken, and measurements of mouth opening, joint range of motion, and finger extension will be recorded.

  2. Step 2

    First Dose Administration

    You will receive the first dose of nemolizumab as a 60 mg subcutaneous injection using a pre‑filled pen.

    The injection is given under the skin (subcutaneous) and the dose is 60 mg per administration.

    This marks the start of the 24‑week treatment period.

  3. Step 3

    Week 4 Visit and Early Evaluation

    Four weeks after the first injection, you will return for a follow‑up visit.

    You will repeat the itch and pain questionnaires (PP‑NRS and PNRS) and the DLQI to evaluate changes from baseline.

    The research team will again measure mouth opening, joint range of motion, finger extension, and dysphagia symptoms.

    Any side effects, such as mild skin reactions or headache, will be recorded.

  4. Step 4

    Ongoing Treatment and Periodic Assessments

    You will continue to receive nemolizumab injections according to the study schedule, typically every few weeks, until week 24.

    At each scheduled visit (for example, weeks 8, 12, 16, 20), the same set of questionnaires and physical measurements will be repeated.

    The study team will monitor for adverse events and document any reactions.

  5. Step 5

    Final Visit at Week 24

    At the end of the 24‑week period, you will attend the final study visit.

    All questionnaires (PP‑NRS, PNRS, DLQI, global satisfaction Likert scale) will be completed for the last time.

    A final photograph of the affected leg and the last set of physical measurements will be taken.

    The overall safety and effectiveness of the treatment will be evaluated based on the collected data.

Who can join the trial?

10 criteria

  • Age 12 years or older – you must be at least twelve years old.
  • Social security coverage – you need to be enrolled in a social security or similar health insurance program.
  • Dystrophic epidermolysis bullosa (DEB) – a rare skin condition that makes the skin very fragile and prone to blisters; you must have the recessive or dominant form that has been confirmed by a special skin test called skin immunomapping or by DNA testing (also called molecular analysis).
  • Itching score of 4 out of 10 or higher – you must report a baseline level of itching (known as pruritus) that is at least moderate.
  • No other skin creams or ointments except those approved by the study doctor; the study allows continued use of VYJUVEK gel if you are already using it, but not on the left leg.
  • Effective birth control – you must use a reliable method to prevent pregnancy during the study.
  • Not pregnant, not breastfeeding, and not planning pregnancy – you must not be pregnant, not be feeding a baby, and not plan to become pregnant while in the study.
  • Overall good health – you should be free of other serious illnesses or conditions that the doctor thinks could affect the study results or put you at risk.
  • Willing to follow study instructions and attend visits – you must be able to do everything the study asks, including coming to all scheduled appointments.
  • Can understand and sign the consent form – you need to be able to read and agree to the study’s Informed Consent (or Assent for minors) document.

Who cannot join the trial?

7 criteria

  • Use of DUPILUMAB or JAK inhibitor: If you have taken these medicines, you must wait at least two months before joining the study.
  • Unstable or uncontrolled asthma: Asthma is a lung condition that makes breathing difficult. If your asthma is not well‑controlled, you cannot participate.
  • Other medical problems: Having other serious illnesses or health conditions at the same time may keep you from joining.
  • Family member in the same household also enrolled: If someone you live with is already part of this study, you cannot take part.
  • Recent use of systemic products: Any medication taken by mouth, injection, or that affects the whole body, which the doctor thinks could be risky or affect the study results, must not have been used within 30 days before the first visit.
  • Vulnerable persons: People who may not be able to give full consent on their own (such as certain minors, pregnant individuals, or those with limited decision‑making ability) are excluded.
  • Allergy to Nemolizumab ingredients: If you have ever had a reaction or sensitivity to any component of the study drug Nemolizumab, you cannot join.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Nemluvio is an experimental medicine that contains a lab‑made protein called nemolizumab. It works by blocking a signal in the body that causes intense itching. In this study, participants receive the medicine as a small injection under the skin using a convenient pre‑filled pen. The researchers are testing whether Nemluvio can safely reduce the severe itch that people with dystrophic epidermolysis bullosa (DEB) often experience.

What is already known about the treatment

Nemolizumab - It is given as a subcutaneous injection using a pre‑filled pen that contains a powder mixed with a liquid to make a solution. The drug is a monoclonal antibody that is already approved in some countries for severe itching in atopic dermatitis and is now being studied for dystrophic epidermolysis bullosa. It works by attaching to the IL‑31 receptor on skin cells, which blocks a signal that causes itch. This makes it an immunomodulating biologic agent.

Investigated diseases

Dystrophic epidermolysis bullosa - Dystrophic epidermolysis bullosa is a rare inherited disorder that makes the skin extremely fragile. Even minor friction or trauma can cause the outer layer of skin to separate, forming blisters. Over time the repeated blistering leads to thick scar tissue and areas of skin that are prone to tearing. The scarring can affect joints, reducing their range of motion and sometimes causing contractures. In the mouth and esophagus, scar formation may cause difficulty swallowing.
Trial detailsLast updated 18 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526417-28-00Protocol code26-PP-01Estimated enrolment15 patientsSponsorCentre Hospitalier Universitaire De Nice

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.