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Study of Rocatinlimab in Adults with Prurigo Nodularis Not Adequately Controlled by Topical Treatments

Fast replyInvestigationalNo placebo
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What is this trial about?

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

Prurigo Nodularis is a skin condition characterized by extremely itchy nodules (bumps) on the skin that appear due to chronic scratching. The condition can significantly affect quality of life through intense itching, skin pain, and sleep problems. This study will test a new medication called Rocatinlimab (also known as AMG 451) in adults who have not responded well to topical treatments or cannot use them.

The purpose of this research is to evaluate how well different doses of Rocatinlimab work compared to placebo in reducing itching in people with Prurigo Nodularis. The medication will be given as a subcutaneous injection (an injection under the skin). The study will last for 52 weeks, during which participants will receive either Rocatinlimab or placebo.

Throughout the study, participants will need to keep a daily record of their symptoms, including itching intensity and skin pain. Doctors will regularly examine the skin nodules and monitor how the treatment affects participants' quality of life and sleep. The study will also track any side effects that may occur during the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be confirmed if you are 18 years or older and have been diagnosed with prurigo nodularis for at least 3 months

    You must have at least 20 nodules distributed on both legs, arms, and/or trunk

    Your condition must show inadequate response to previous topical treatments or these treatments must be unsuitable for you

  2. Step 2

    Daily symptom recording

    You will need to complete a daily electronic diary to record your itching symptoms

    The diary must be completed for at least 4 days within the week before starting treatment

  3. Step 3

    Treatment period

    The study will last for 52 weeks (one year)

    You will receive either rocatinlimab or a placebo through subcutaneous injection (injection under the skin)

    The treatment aims to reduce itching and improve skin condition

  4. Step 4

    Monitoring and assessment

    Regular assessments will track changes in:

    - Itching intensity

    - Skin pain

    - Quality of sleep

    - Overall quality of life

    - Skin lesion appearance

    Any side effects or health changes will be documented throughout the study

Who can join the trial?

7 criteria

  • You must be at least 18 years old or meet the legal age requirement in your country if it is higher than 18
  • You must be willing to provide informed consent before starting any study procedures
  • You must have been diagnosed with prurigo nodularis for at least 3 months, with symptoms including: - Itching lasting more than 6 weeks - Signs of chronic scratching - Multiple itchy lesions and raised, scratched nodules (bumps) on the skin
  • You must report your daily itching severity using an electronic diary for 7 days before starting the study
  • You must have at least 20 nodules spread across both legs, both arms, and/or trunk
  • You must have either: - Not responded well to topical treatments (creams or ointments applied to the skin) - Cannot use topical treatments due to side effects or safety concerns - Previously used systemic treatments (medications taken by mouth or injection) or light therapy
  • You must complete at least 4 daily diary entries about your symptoms in the week before starting the study

Who cannot join the trial?

14 criteria

  • Prior treatment with rocatinlimab or any other investigational drug within 8 weeks before starting the study
  • Active or chronic infections, including tuberculosis or hepatitis B/C
  • History of cancer in the past 5 years (except successfully treated non-melanoma skin cancer)
  • Significant heart problems or uncontrolled high blood pressure
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Current pregnancy or breastfeeding
  • Known allergic reactions to similar medications
  • Major surgery within 8 weeks before starting the study
  • Any condition that could interfere with study participation or increase risk to the participant
  • Use of other medications for treating prurigo nodularis that cannot be stopped during the study
  • Mental health conditions that could affect the ability to follow study procedures
  • Drug or alcohol abuse within the past 6 months
  • Participation in another clinical trial at the same time
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Investigated drugs

  • Rocatinlimab

    is an investigational medication being studied for treating prurigo nodularis, a skin condition that causes intense itching and nodules on the skin. This medication is designed to help patients who haven't responded well to topical treatments (creams or ointments applied to the skin) or who cannot use topical treatments. It works by targeting specific components of the immune system that are involved in causing the intense itching and skin lesions associated with prurigo nodularis.

  • Topical therapies

    refer to various creams, ointments, or lotions that are applied directly to the skin to treat prurigo nodularis. These are standard treatments that patients may have used before trying rocatinlimab.

What is already known about the treatment

Rocatinlimab - A novel biological medication administered through subcutaneous injection that is currently undergoing Phase 3 clinical trials for the treatment of Prurigo Nodularis, a chronic inflammatory skin condition characterized by intensely itchy nodules. This monoclonal antibody works by targeting specific immune system pathways involved in chronic itch and inflammation, particularly focusing on reducing the intensity of pruritus (itching) in patients who haven't responded adequately to topical treatments. As an immunomodulator in clinical development, rocatinlimab represents a potential breakthrough in treating this challenging skin condition, with studies evaluating its efficacy and safety over a 52-week period in comparison to placebo.

Investigated diseases

Prurigo Nodularis - A chronic skin condition characterized by hard, itchy nodules (bumps) that develop on the skin. The condition typically begins with an intense itching sensation that leads to scratching, which then causes the formation of firm, dome-shaped bumps on the skin's surface. These nodules commonly appear on the arms, legs, upper back, and abdomen. The affected areas often become rough and thickened due to repeated scratching. The condition can persist for months or years, with periods of improvement and worsening. The itching associated with Prurigo Nodularis can be severe and often interferes with daily activities and sleep.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510753-10-00Protocol code20230053Estimated enrolment486 patientsSponsorAmgen Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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