A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
This research study is designed to understand the long-term safety of a drug called Nemolizumab in people who suffer from Prurigo Nodularis. Prurigo Nodularis is a skin condition that causes very itchy lumps. This study is specifically for individuals who have already participated in an earlier research study involving Nemolizumab for their Prurigo Nodularis. The main goal is to continue monitoring how safe the medicine is over a longer period. Participants will need to follow a protocol, use a handheld device for recordings, and women of childbearing potential will need to use effective contraception if needed.
At a glance
What is this study about?
This study is about a skin condition called Prurigo Nodularis (PN), which causes very itchy, bumpy skin. The study focuses on a medicine called Nemolizumab, which is being investigated as a possible treatment for PN. This particular study is designed to look at the long-term safety of Nemolizumab. This means researchers want to see if there are any side effects that appear over a longer period when people take the medicine.
It's really important to find safe and effective treatments for conditions like PN, especially since it can be very uncomfortable and affect people's quality of life. By understanding the long-term safety, doctors and researchers can get a fuller picture of Nemolizumab's potential as a treatment and help guide its development.
Since this study is specifically for people who have already been part of a previous Nemolizumab study for PN, it allows researchers to gather more extensive safety data from a group of individuals who already have experience with the drug. This long-term monitoring helps ensure that any potential benefits are weighed against any ongoing risks.
Key takeaways
- This study evaluates the long-term safety of Nemolizumab for Prurigo Nodularis.
- It's only for adults who previously participated in a Nemolizumab study for this condition.
- Participants will use a handheld device for weekly recordings.
- Women of childbearing potential must use effective contraception.
- The study aims to gather more comprehensive safety data on Nemolizumab.
Who may be eligible?
This study is for adults generally aged 18 or older who have Prurigo Nodularis. A key requirement is that you must have already taken part in a previous research study for Nemolizumab for your Prurigo Nodularis. This includes people who finished a main Phase 3 study, were in a Phase 2a study, or who completed a certain part of a durability study.
There are also some important rules about who cannot join. You won't be able to take part if you had a serious side effect in a previous Nemolizumab study that your doctor thinks makes it unsafe for you to continue. Also, pregnant or breastfeeding women, or those planning to get pregnant, cannot participate. Your body weight must also be at least 30 kg (about 4 stone 10 pounds).
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.
- Are you 18 years old or older?
- Do you have Prurigo Nodularis?
- Have you already participated in a Nemolizumab study for Prurigo Nodularis?
- Are you not pregnant, breastfeeding, or planning to become pregnant?
- Do you weigh at least 30 kg (about 4 stone 10 pounds)?
What does participation involve?
If you join this study, you'll be taking the medicine Nemolizumab. The main commitment is to attend regular appointments and follow the study instructions carefully. You will be asked to make weekly recordings using a special electronic handheld device provided for the study.
If you are a woman who could become pregnant, you'll need to strictly avoid getting pregnant throughout the study and for 12 weeks after your last dose of the medicine. This usually means using very effective birth control or choosing not to have sex during this time. You'll also need to sign a consent form, which means you understand what the study involves and agree to take part.
Potential risks and benefits
Locations (164)
- Galderma Investigational SiteVerified postcodeBirmingham, United States
- Galderma Investigational SiteVerified postcodeBirmingham, United States
- Galderma Investigational SiteVerified postcodeFountain Valley, United States
- Galderma Investigational SiteVerified postcodeLos Angeles, United States
- Galderma Investigational SiteVerified postcodeSan Diego, United States
- Galderma Investigational SiteVerified postcodeSan Diego, United States
- Galderma Investigational SiteVerified postcodeSanta Monica, United States
- Galderma Investigational SiteVerified postcodeWashington D.C., United States
- Galderma Investigational SiteVerified postcodeAventura, United States
- Galderma Investigational SiteVerified postcodeDelray Beach, United States
- Galderma Investigational SiteVerified postcodeHollywood, United States
- Galderma Investigational SiteVerified postcodeLargo, United States
Common questions
What is Prurigo Nodularis?
It's a skin condition that causes very itchy, firm lumps on the skin.
What is Nemolizumab?
It's a medicine being tested to see if it can help treat Prurigo Nodularis.
Do I have to have been in another study to join this one?
Yes, this study is only for people who have already participated in a previous Nemolizumab study for Prurigo Nodularis.
What does 'long-term safety' mean?
It means the researchers want to monitor the medicine's effects and any potential side effects over an extended period.
Can pregnant women join this study?
No, pregnant or breastfeeding women, or those planning a pregnancy, cannot participate.
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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