A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
Prurigo nodularis is a long-term skin condition that causes hard, intensely itchy lumps to form on the body. Constant scratching can break the skin, cause pain, and make sleeping difficult. Many people find that standard treatments, such as steroid creams, do not work well enough. This clinical trial is testing an experimental medicine called rocatinlimab. Researchers want to see if rocatinlimab can significantly reduce itching, clear skin lumps, and relieve skin pain over a 52-week period. They will also measure improvements in sleep and everyday quality of life. To see if the medicine really works, half the participants may receive the active drug while others receive a dummy treatment (placebo). The study is open to adults aged 18 and over who have prurigo nodularis that has not responded to skin creams, or who cannot safely use these creams.
At a glance
What is this study about?
Prurigo nodularis is a skin condition known for causing hard, intensely itchy lumps (nodules). The urge to scratch is often overwhelming. Over time, repeated scratching can damage the skin, cause bleeding, and create a cycle where itching leads to more scratching and worse skin damage. This constant discomfort frequently leads to poor sleep, low mood, and distress.
For many patients, regular skin treatments like prescription creams and ointments simply do not work well enough. This Phase 3 trial is testing whether a new medicine called rocatinlimab can help break this cycle. Rocatinlimab works from the inside out by calming down parts of the body's immune system that drive itching and skin inflammation.
During this year-long study, researchers want to see if rocatinlimab safely reduces daily itching and helps skin lumps clear up. They will also look closely at how the treatment affects skin pain, sleep quality, and daily wellbeing. The results will help doctors understand whether rocatinlimab could become a useful new option for people living with severe prurigo nodularis.
Key takeaways
- The trial tests a new medicine called rocatinlimab for adults with prurigo nodularis.
- The main goal is to see if it reduces severe daily itching and clears skin lumps.
- Participation lasts for roughly 52 weeks and includes regular clinic visits.
- You have an equal chance of receiving either the study drug or an inactive placebo.
- Taking part is completely voluntary, and you can stop at any time.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with prurigo nodularis. It is open to both men and women.
To be considered, you should have ongoing, noticeable skin nodules and moderate to severe itching. You should also be someone whose condition has not improved enough after using prescription skin creams, or someone who is unable to use those types of topical medicines for medical reasons.
Before taking part, the study team will carry out health checks, including a review of your medical history and any other medications you take. This is done to ensure it is completely safe for you to take part.
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.
- I am aged 18 or older.
- I have been diagnosed with prurigo nodularis.
- I experience persistent, severe skin itching and hard skin lumps.
- Prescription skin creams have not worked well enough for me, or I cannot use them.
- I am willing to attend clinic visits and complete daily symptom questionnaires for one year.
What does participation involve?
Taking part in this study lasts for about 52 weeks (one year). During this time, you will have regular appointments at a hospital or clinical trial centre. You will receive either the study medicine (rocatinlimab) or a dummy treatment (placebo) given as an injection under the skin. A computer randomly decides which treatment you receive, and neither you nor your study doctor will know which one you are getting. At your visits, doctors will examine your skin, check your general health, and occasionally take blood and urine samples. You will also be asked to keep track of your daily itching levels, skin pain, and sleep quality using a simple electronic diary.
Potential risks and benefits
Locations (15)
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Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any improvements are truly caused by the study medicine rather than by chance.
Do I have to pay to take part?
No. The study medication, tests, and doctor visits related to the trial are provided free of charge. Travel costs to and from the clinic are usually reimbursed.
Can I carry on using my regular skin moisturisers?
Usually, yes. You can often keep using gentle moisturisers, but you should discuss all skin products and medications with the trial team before starting.
What happens if my itching gets much worse during the study?
The study team monitors your symptoms closely. If your itching becomes too severe, the doctors can provide rescue treatments to help you stay comfortable.
Can I leave the study early if I want to?
Yes. You have the right to withdraw from the clinical trial at any point, and your normal medical care will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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