A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis
This research study is testing a new medication called lebrikizumab for adults and teenagers who have moderate to severe eczema on their hands and/or feet. This type of eczema can be very uncomfortable and affect daily life. The study wants to find out if lebrikizumab can help improve the skin and reduce symptoms like itching, compared to a placebo (a dummy treatment with no active medicine). Researchers will also be checking for any side effects to make sure the treatment is safe. If you have chronic hand and foot eczema that hasn't responded well to other treatments, this study might be an option for you.
At a glance
What is this study about?
This study is about understanding how a new medicine, lebrikizumab, could help people who suffer from a difficult type of eczema that affects their hands and feet. This condition, often called atopic hand and foot dermatitis, can cause red, itchy, and sometimes painful skin, making everyday tasks challenging. Current treatments don't always work for everyone.
Researchers want to compare lebrikizumab with a 'placebo', which looks exactly like the real medicine but contains no active ingredients. This helps them figure out if any improvements seen are truly due to lebrikizumab. By running this study, they hope to find a more effective treatment option for those living with persistent hand and foot eczema.
This important research is in 'Phase 3'. This means that the treatment has already undergone earlier testing and shown some promise. Now, it's being tested on a larger group of people to confirm its effectiveness and safety before it could potentially become a widely available treatment.
Key takeaways
- This study is for adults and teenagers with moderate to severe hand and foot eczema.
- It's testing a new medicine called lebrikizumab against a dummy treatment (placebo).
- The study lasts for up to 32 weeks, with regular check-ups.
- Potential benefits include trying a new treatment; potential risks include side effects.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you would generally need to be an adult or a teenager aged 12 or older. A key requirement is that you must have been diagnosed with chronic eczema on your hands and/or feet for at least a year. The eczema needs to be affecting at least two areas (like your left hand and right foot) and be considered moderate to severe by the research doctors.
Another important point is that your eczema should cause noticeable itching, and previous treatments applied to the skin, such as creams or ointments, haven't worked well for you in the last six months, or you haven't been able to use them for medical reasons.
There are also some reasons why you might not be able to join. For example, if your hand or foot rash is caused by an allergic reaction to something you've touched (called allergic contact dermatitis) that shows up on a patch test, or if doctors suspect it's a different type of eczema triggered by proteins, then this study might not be suitable 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.
- Are you 12 years old or older?
- Do you have eczema specifically on your hands and/or feet that's been diagnosed for at least a year?
- Do you have moderate to severe eczema on at least two areas of your hands and/or feet?
- Has previous cream or ointment treatment for your hand and foot eczema not worked well for you recently?
- Does your hand and foot eczema cause significant itching?
What does participation involve?
If you decide to take part, the study will last for up to 32 weeks, which is about 7 to 8 months. Initially, there will be a 6-week 'screening' period where doctors will check if you're a good fit for the study. Following this, you'll enter a 16-week 'treatment period' where you'll receive either lebrikizumab or the placebo. After you've finished taking the study medicine, there will be a final check-up visit about 12 weeks later to make sure you're doing well and to see if there are any lasting effects.
Potential risks and benefits
Locations (79)
- First OC Dermatology Research IncVerified postcodeFountain Valley, United States
- Dermatology Research AssociatesVerified postcodeLos Angeles, United States
- Encore Medical ResearchVerified postcodeHollywood, United States
- Research Associates of South Florida - Miami - Southwest 8th StreetVerified postcodeMiami, United States
- Renstar Medical ResearchVerified postcodeOcala, United States
- DeNova ResearchVerified postcodeChicago, United States
- Southern Indiana Clinical TrialsVerified postcodeNew Albany, United States
- Revival Research Institute, LLCVerified postcodeTroy, United States
- MediSearch Clinical TrialsVerified postcodeSaint Joseph, United States
- Care Access - HobokenVerified postcodeHoboken, United States
- Optima Research - BoardmanVerified postcodeBoardman, United States
- Progressive Clinical ResearchVerified postcodeSan Antonio, United States
Common questions
What is lebrikizumab?
Lebrikizumab is an investigational medicine being tested to see if it can help people with eczema on their hands and feet.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine.
How long will the study last?
The study will last for up to 32 weeks, including initial checks, a treatment period, and a final follow-up visit.
Will I know if I'm getting the real medicine or the placebo?
During the main part of the study, you won't know whether you are receiving lebrikizumab or the placebo. This helps ensure fair results.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.