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Active not recruitingPHASE3INTERVENTIONAL

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

This research study is looking into a new treatment called rocatinlimab for a skin condition called prurigo nodularis. If you have this condition, you might experience very itchy, firm lumps on your skin. The study aims to find out if rocatinlimab can help reduce the intense itching and improve the skin's appearance, compared to a placebo (a dummy medicine with no active ingredients). This is a 'double-blind, placebo-controlled' study, meaning neither you nor your doctor will know if you're getting the active medicine or the placebo. This helps ensure fair and accurate results. Researchers will be carefully checking how participants' itching levels change and how their overall skin condition improves over 24 weeks.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Amgen
Enrolment target
469
Start
18 Jul 2024
Estimated completion
17 Jan 2027

What is this study about?

Prurigo nodularis is a skin condition that causes very itchy, firm lumps or 'nodules' to appear on your skin. The itching can be severe and can significantly affect your daily life and sleep. Current treatments don't always work well for everyone.

This study is testing a new medicine called rocatinlimab to see if it can help people who have prurigo nodularis. It's a 'Phase 3' study, which means it's one of the final stages of testing, after earlier studies have shown promising results. The main goal is to find out if rocatinlimab is better than a dummy medicine (called a placebo) at reducing the severe itching and improving the overall condition of the skin over a period of 24 weeks.

Taking part in a study like this could help researchers understand more about prurigo nodularis and potentially lead to new and better treatments in the future. It's an important step in finding ways to help people manage this challenging skin condition.

Key takeaways

  • This study is for adults with very itchy skin due to prurigo nodularis.
  • It tests a new medicine called rocatinlimab against a dummy medicine (placebo).
  • The main aim is to see if it reduces itching and improves skin over 24 weeks.
  • You won't know if you're getting the active medicine or the placebo.
  • Participation involves regular clinic visits and keeping a daily itch diary.
  • Your decision to join or leave the study is entirely voluntary and won't affect your healthcare.

Who may be eligible?

To join this study, you need to be an adult at least 18 years old and have been diagnosed with prurigo nodularis for at least 3 months. You should have at least 20 itchy lumps (nodules) on your body, for example, on both your arms, legs, or torso. Also, you must have tried and not responded well to strong skin creams, or your doctor has advised against using them for safety reasons.

There are also some reasons why you might not be able to join. For instance, if you have other skin or body conditions that could make it difficult to properly check the study results, or if your prurigo nodularis is caused by certain medicines, nerve problems, or mental health conditions, you might not be eligible. Also, if you've recently taken certain strong medicines that affect your immune system, or had live vaccines, you might need to wait a while before you can participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you had prurigo nodularis for at least 3 months?
  3. Do you have at least 20 itchy lumps (nodules) on your body?
  4. Have strong skin creams not worked well for your prurigo nodularis, or has your doctor advised against them?
  5. Do you have any other significant skin or health conditions that might interfere with skin assessments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, rocatinlimab, or a placebo (a dummy medicine). Neither you nor your study doctor will know which one you are getting. You would have regular appointments at the study clinic, where doctors and nurses would check your health, assess your skin condition, and ask about your itching levels. You'd also be asked to keep a daily diary of your itching. These visits would happen over a period of 24 weeks, followed by further checks to monitor your progress and safety. The full duration of your participation would involve regular check-ups and assessments, both while you're receiving the study medicine and for a period afterwards to ensure your well-being.

Potential risks and benefits

By taking part, you might benefit from receiving a new medicine that could reduce your itching and improve your skin, or you might help others by contributing to medical research. However, there's also a chance you could receive the placebo and not get any active treatment. Like all medicines, rocatinlimab may have side effects, which the study team will discuss with you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (192)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham
    Verified postcode
    Birmingham, United States
  • First OC Dermatology
    Verified postcode
    Fountain Valley, United States
  • Los Angeles Universal Research Center
    Verified postcode
    Los Angeles, United States
  • Paradigm Clinical Research Center Inc
    Verified postcode
    San Diego, United States
  • Wolverine Clinical Trials
    Verified postcode
    Santa Ana, United States
  • Direct Helpers Research Center
    Verified postcode
    Hialeah, United States
  • Southern Clinical Research
    Verified postcode
    Miami, United States
  • University of Miami Hospital
    Verified postcode
    Miami, United States
  • Miami Dermatology and Laser Institute
    Verified postcode
    Miami, United States
  • Wellness Clinical Research
    Verified postcode
    Miami Lakes, United States
  • Clinical Research Trials of Florida Inc
    Verified postcode
    Tampa, United States
  • Olympian Clinical Research - Tampa
    Verified postcode
    Tampa, United States

Common questions

What is prurigo nodularis?

It's a skin condition causing very itchy, firm lumps (nodules) on your skin.

What is rocatinlimab?

It's an investigational new medicine being tested to treat prurigo nodularis.

What does 'placebo-controlled' mean?

It means some people will get the active medicine, and others will get a dummy medicine, without anyone knowing who gets which, for fair testing.

How long will the study last for me?

You will be actively involved for about 24 weeks, with follow-up appointments afterwards, but the total duration varies per person. The study team will provide specifics.

Can I stop participating if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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