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Study on the Long-Term Safety and Effectiveness of Nemolizumab 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. This condition is characterized by itchy, hard bumps on the skin. The study is testing a treatment called Nemolizumab, which is given as a solution for injection. Nemolizumab is also known by its code name, CD14152 or CIM331. The main goal of the study is to assess the long-term safety of Nemolizumab in people with Prurigo Nodularis.

Participants in the study will receive Nemolizumab injections over a period of time. Some participants may receive a placebo instead. The study will monitor the safety of the treatment and how well it works in reducing the symptoms of Prurigo Nodularis. Participants will have regular visits to the study site to receive their injections and to have their health and symptoms checked by the study team.

The study will last for several years, allowing researchers to gather information on the long-term effects of Nemolizumab. Participants will be asked to record their symptoms and any changes they notice using a handheld electronic device provided by the study. This information will help researchers understand how Nemolizumab affects Prurigo Nodularis over time and whether it is a safe and effective treatment option for this 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing previous participation in related studies and ensuring compliance with specific criteria.

    Female participants of childbearing potential must agree to use approved contraception methods throughout the study and for 12 weeks after the last injection.

  2. Step 2

    Treatment administration

    The study involves the administration of nemolizumab, a solution for injection, given subcutaneously. The frequency and dosage are determined by the study protocol and the investigator's assessment.

    Participants are required to attend regular visits for the administration of the medication and monitoring of their condition.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, participants are monitored for any adverse events or changes in their condition. This includes regular assessments of skin condition and overall health.

    Participants are required to record their symptoms and any side effects using an electronic device provided for the study.

  4. Step 4

    Follow-up visits

    Participants attend follow-up visits at specified intervals to evaluate the effectiveness and safety of the treatment. These visits continue up to Week 184.

    During these visits, various assessments are conducted, including the evaluation of skin lesions and quality of life measures.

  5. Step 5

    Completion of study

    The study is estimated to conclude by August 15, 2027. Upon completion, participants undergo a final assessment to evaluate the long-term effects of the treatment.

    Participants are informed about the outcomes of the study and any further steps if necessary.

Who can join the trial?

13 criteria

  • Individuals must have participated in a previous study involving the medication **nemolizumab** for **Prurigo Nodularis** (PN), a skin condition characterized by itchy bumps.
  • Female participants who can have children must agree to use a reliable method of birth control during the study and for 12 weeks after the last dose of the study medication. Acceptable methods include:
    • Complete abstinence from sexual activity, if it aligns with the participant's lifestyle.
    • Progestogen-only birth control pills.
    • Using a male condom along with a cap, diaphragm, or sponge with spermicide (except in Germany, where this is not considered adequate).
    • Combined hormonal birth control methods, such as pills, vaginal rings, or patches.
    • Hormonal injections or implants.
    • Intrauterine devices (IUDs) or hormone-releasing systems placed in the uterus.
    • Surgical procedures like tubal ligation (tying the fallopian tubes) or tube inserts done at least 3 months before the study.
    • Partner's vasectomy performed at least 3 months before the study.
    • Female participants who cannot have children must meet one of the following:
      • No menstrual periods for 1 year before the study, confirmed by a hormone test.
      • Had a hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), or bilateral oophorectomy (removal of both ovaries) at least 3 months before the study.
      • Participants must be willing and able to follow all study requirements, including using an electronic device to record information weekly.
      • Participants must understand and sign a consent form before any study-related procedures are done.

Who cannot join the trial?

4 criteria

  • Individuals who do not have Prurigo Nodularis, a skin condition characterized by itchy bumps, cannot participate.
  • Participants must be within the specified age range, which is not detailed here, but typically includes adults and sometimes older children.
  • Both males and females are eligible, so gender is not a reason for exclusion.
  • Individuals considered part of a vulnerable population, such as those unable to give informed consent, are not included.
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Investigated drugs

Nemolizumab (CD14152) is a medication being studied for its safety and effectiveness in treating prurigo nodularis, a skin condition characterized by itchy nodules. This trial aims to understand how well patients tolerate the medication over a long period and how effective it is in managing the symptoms of the condition.

What is already known about the treatment

Nemolizumab – Nemolizumab is administered as an injection under the skin, typically in a clinical setting. It is currently being studied in clinical trials to evaluate its long-term safety and effectiveness for treating prurigo nodularis, a skin condition characterized by itchy nodules. The medication works by blocking a specific protein involved in the inflammatory process, which helps reduce itching and skin lesions. Nemolizumab is classified as a monoclonal antibody, a type of medication designed to target specific molecules in the body.

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 nodules typically appear on the arms, legs, and other areas that are easy to reach. Over time, the skin may become thickened and discolored due to persistent scratching and irritation. The exact cause of Prurigo Nodularis is not well understood, but it is often associated with other conditions such as eczema or liver disease. The condition can significantly impact the quality of life due to the persistent itch and discomfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514502-31-00Protocol codeRD-06-SPR-202699Estimated enrolment508 patientsSponsorGalderma S.A.

sourced from the EU Clinical Trials Register and site verification

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