The UP0110 Study is testing an investigational drug in atopic dermatitis (you may also know this as eczema). The study is separated into two parts: part A and part B. We are currently inviting participants to enroll in part B of the study.
Part A of this study was a first-in-human study, which means that this was the first time that the investigational drug was given to humans. In part A, over 60 healthy volunteers in the USA received a single dose of the investigational drug. This part is now complete.
In part B, the investigational drug will be evaluated when used by people with atopic dermatitis. The purpose of this is to find out whether the investigational drug:
- Is effective in people with atopic dermatitis who have not responded to or do not tolerate other treatments applied to the skin
- Is well tolerated (i.e. whether it causes any side effects)
The drug is called ‘investigational’ because it is currently not approved by health authorities for treating atopic dermatitis and is being evaluated in clinical research studies such as this one. Health authorities have given permission for it to be used in the UP0110 Study.
The UP0110 Study is comparing the investigational drug with a placebo. Placebo looks like the investigational drug, but contains no medicinally active ingredients. Comparing against placebo helps the study team find out whether any changes observed (good or bad) are linked to the investigational drug.
You will have a 2 in 3 (66.7%) chance of receiving the investigational drug, and a 1 in 3 (33.3%) chance of receiving placebo. Neither you nor the study team will know or be able to choose which study drug (investigational drug or placebo) you receive – this will be picked randomly by a computer. Randomly means down to chance, like pulling names out of a hat.
Whichever study drug you are assigned to (investigational drug or placebo), you will receive it in the same way – by intravenous infusion. Infusion means the study drug will flow slowly into one of your veins, through a small thin tube placed into one of your veins. Currently it is not possible to give the investigational drug orally (by mouth) because of how it works and how it is being made. However, researchers will keep looking for more convenient ways to deliver it in the future.
Your participation in the UP0110 Study will include a total of 16 study visits and will last up to 26 weeks. Some of the visits will be phone calls. The study will consist of the following periods:
- Screening – If you are interested in taking part, you will visit your nearest study center to have tests. The results of these tests will show whether you are able to take part in the study.
- Study Treatment – Over this period, you will receive your assigned study drug on several occasions, and have scheduled study visits via phone call or at the study center (2 visits may include overnight stays). Visits will include tests and assessments to check your responses to your study drug.
- Safety Follow-Up – At the end of the study, you will visit the study center for a number of follow-up assessments after you have received your last dose of study drug.
If you are one of the first eight participants in part B, you will have to stay at the study center overnight for monitoring. This will include one stay for two nights and two stays for one night during the first month.
All medicines can have side effects. One of the aims of the UP0110 Study is to find out more about any side effects (good or bad) that people taking the investigational drug or placebo may experience.
Before you decide whether you would like to join the study, you will receive more detailed information on what side effects of the investigational drug are already known from previous clinical research; you are encouraged to talk to your study doctor about any potential side effects.
Throughout the study, your health and well-being will be closely monitored. If you have any specific concerns or think you (or the person you care for) might be experiencing a side effect, you can talk to the study team at any time.