A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
Prurigo nodularis is a long-term skin condition that causes hard, intensely itchy bumps on the skin. The urge to scratch can be overwhelming, leading to broken skin, pain, and poor sleep. This trial is testing a medicine called nemolizumab. Nemolizumab is designed to block the body signals that trigger itching and swelling. Researchers want to find out how safe the medicine is when taken over a longer time, and how well it helps clear skin bumps and relieve itching. The study is for adults aged 18 and over who have prurigo nodularis. Some people taking part may have already been in an earlier trial of this medicine. Taking part involves having regular clinic check-ups, receiving the medicine, and sharing details about your itch, pain, sleep, and overall quality of life over several years.
At a glance
What is this study about?
Prurigo nodularis is a chronic skin problem marked by firm, crusty lumps that itch intensely. This constant itching often leads to repeated scratching, which makes the bumps worse and can cause painful open sores. Living with this condition can make it very difficult to get a good night's sleep and can affect everyday activities, mood, and mental health.
In this Phase 3 clinical trial, researchers are testing an experimental treatment called nemolizumab. The medicine is designed to stop specific chemical messages in the body that cause itching and swelling. By interrupting these signals, researchers hope to break the cycle of itching and scratching, giving the skin a chance to heal.
The main goal of this study is to see if nemolizumab is safe to use over a longer period, up to around three and a half years. Doctors also want to learn if it keeps itch levels low, improves sleep, and reduces skin bumps over time. This research matters because current treatment options for prurigo nodularis are limited, and new long-term treatments are urgently needed.
Key takeaways
- Tests a targeted injection medicine called nemolizumab for prurigo nodularis.
- Aims to check the long-term safety of the medicine and how well it stops severe itching.
- Open to adults aged 18 and older with prurigo nodularis.
- Involves clinic visits, skin checks, and symptom diaries over up to three and a half years.
- Participation is completely voluntary and you can leave at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with prurigo nodularis. Men and women can both take part.
Some participants may be invited to join after finishing an earlier research study with this medicine. To be eligible, you will need to have active symptoms of the condition, such as noticeable skin bumps and severe itching.
Because this is a clinical trial, there are health criteria to ensure your safety. For example, people with certain other serious health issues or specific skin conditions may not be able to join. The study team will review your full medical history and current medications to see if the trial is right for you.
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 have itchy, hard bumps or nodules on my skin.
- I am willing to attend regular clinic visits over a long-term period.
- I am happy to record my itch, sleep, and pain levels on study forms.
What does participation involve?
Taking part in this study involves receiving nemolizumab, which is usually given as an injection under the skin. You will visit the clinic regularly so doctors can check your skin, monitor your health, and test for any side effects. You will be asked to fill in simple questionnaires about your daily itch, pain levels, and how well you are sleeping. The study tracks your progress over a long period, lasting up to 184 weeks (about three and a half years). All study-related medicines, tests, and visits are provided at no cost to you.
Potential risks and benefits
Locations (11)
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedAustria
- —UnverifiedItaly
Common questions
What is nemolizumab?
Nemolizumab is an injection medicine that targets and blocks the proteins in your body that trigger severe itch and skin swelling.
Will I receive a dummy drug (placebo)?
This long-term study focuses on the ongoing safety and effects of nemolizumab. The study team will explain the exact treatment plan before you agree to join.
How long will I be in the study?
The study lasts for up to 184 weeks, which is about three and a half years, to see how the medicine works over time.
Do I have to pay to take part?
No. The study medicine, appointments, and tests are free. Many trials also help cover reasonable travel expenses to the clinic.
What happens if I change my mind?
You are free to leave the trial at any point. Your decision will not affect the relationship with your healthcare team or your standard NHS care.
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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.