Is eczema impacting
your daily life?
The symptoms of atopic dermatitis (AtD, which is often also referred to as ‘eczema’) can be difficult to manage. Severe itching, the presence of skin rashes, cracked, inflamed, thick, rough and leathery or darker patches of skin can have a significant impact on the lives of people living with AtD. This can be difficult to deal with daily, even with taking different medications and creams for the condition.
If you have eczema, you may be eligible for The PossibILity Study. This study is evaluating an investigational drug called galvokimig. We hope to learn how well it works to help relieve atopic dermatitis symptoms (this is called efficacy), what kind of side effects participants experience (this is called safety), how it moves through the body (this is called pharmacokinetics), and what it does inside the body (this is called pharmacodynamics).
Participants may receive:
- Close care and monitoring from specialist healthcare professionals
- Compensation for travel expenses
You may be able to join the PossibILity Study if:
- You are at least 18 years old
- You have been diagnosed with atopic dermatitis for at least 12 months
- More than 10% of your skin is currently affected by atopic dermatitis (the palm of your hand is about 1% of body surface area)
- You have used topical medications (e.g. medicated creams or ointments) for atopic dermatitis in the past 6 months that were not entirely satisfactory
There are additional criteria that need to be met, which the study team at the study center will discuss with you.
What can participants expect?
The study will last a maximum of about 62 weeks (15.5 months), with up to 30 study visits.
The PossibILity Study will include 4 periods:
- Screening Period: About 4 weeks
- Two Intervention Periods: About 52 weeks (1 year) total, divided between:
- Initial Intervention Period: 16 weeks (4 months)
- Maintenance Intervention Period: 36 weeks (9 months)
- Safety Follow-Up Period: 6 weeks
Period
Galvokimig or Placebo
(4 months)
Galvokimig or Placebo
(9 months)
Will I receive any study medication?
After participants are accepted for the study, they will be randomly assigned (as if by picking a number from a hat) to receive either the study medication or placebo. The placebo does not contain any medicinally active ingredients and is given the same way as the study medication. Placebo is used to be able to measure the effect of the investigational drug.
During the first 16 weeks of receiving study medication, participants will receive either galvokimig or placebo. Neither the participant nor the study doctor will know which of the options they are receiving.
After the 16-week Initial Intervention Period, participants will enter the 36-week Maintenance Intervention Period. Participants who previously received galvokimig will keep receiving the same dose level of galvokimig they were on before or switch to another dose level, depending on the evolution of their AtD symptoms.
Participants who received placebo in the Initial Intervention Period and whose AtD did not improve will start receiving galvokimig. The other participants will continue to receive placebo during the Maintenance Intervention Period.
If AtD symptoms flare up during the study, participants can discuss with their study doctor if they can receive medication other than the study medication to help with their AtD symptoms.
The PossibILity Study Journey
This graphic represents the PossibILity Study Journey:
What is Atopic Dermatitis?
Atopic dermatitis (AtD, also often referred to as eczema) is a condition that can make your skin red, itchy, and inflamed but can look different on different skin types. It is common in children but can occur at any age. Atopic dermatitis is a long-lasting (chronic) condition that tends to flare up periodically. It can be managed with treatments to ease the symptoms. But even if you are taking your treatment as directed, atopic dermatitis symptoms can still be challenging.
Why is clinical research important?
Clinical research takes place in clinical studies (also called clinical trials). It is essential for advancing the management or treatment of medical conditions and diseases. All potential medications must be examined in clinical studies before they can be approved and prescribed for people to use.
Participating in research can lead to discovering new treatments. By joining a study, you are contributing to medical advancement that can benefit others in the future.
Global Trial Locations
United States
- Boca Raton
- Bowling Green
- Bronx
- Chicago
- Coral Gables
- Dallas
- Frisco (2 locations)
- Miami
- New Albany
- New York
- Oceanside
- Omaha
- Philadelphia
- Santa Monica
- Savannah
- Sugarland
- Troy (2 locations)
- Wheaton
Canada
- Edmonton
- Hamilton
- Toronto
- Vancouver
Bulgaria
- Lovech
- Pleven
- Plovdiv
- Sevlievo
- Sofia (3 locations)
Czech Republic
- Nachod
- Ostrava-Poruba
- Prague (5 locations)
Germany
- Bad Bentheim
- Dresden
- Frankfurt
- Leipzig
- Luebeck
- Mahlow
Hungary
- Budapest
- Debrecen
- Pecs
Poland
- Chorzow
- Katowice
- Krakow (4 locations)
- Lodz (2 locations)
- Sosnowiec
- Tarnow
- Warszawa (2 locations)
- Wroclaw
United Kingdom
- London (2 locations)
- Salford
- Sheffield
Japan
- Habikino
- Kyoto
- Nagasaki-shi
- Nagoya
- Sakai
- Sapporo
- Tachikawa-shi
- Yokohama
Frequently Asked Questions
At each visit, the study doctor will ask you questions about your eczema (like the severity of itching, how symptoms are impacting quality of life, etc.). During some visits, you will also have an electrocardiogram (or ECG) where a machine records the electrical activity of your heart through small, sticky patches attached to your chest, arms, and legs. You will have blood and urine tests. Blood will be taken at all visits. The amount of blood taken is very small, and the study team will only take blood as required.
Study visits will generally last up to 2 hours. Some visits can take around 4 hours. All study visits are at the study center. The tests and assessments include (but are not limited to) the following:
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Questions about your atopic dermatitis: You will answer questions about your condition, the symptoms you’re experiencing and how this impacts your quality of life. |
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Physical examination: A check of your overall physical health. This will include examination of your skin to look at the areas where you have active atopic dermatitis symptoms. |
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Vital signs: Weight, height, and vital signs (blood pressure, pulse, breathing rate, and body temperature) |
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Answer at maximum 2 questions at home on an app on a portable electronic device to gather information on your itch level and sleep disturbances due to your atopic dermatitis. These will take a few minutes daily during the 7 days prior to each visit to the study center. |
Before you decide to join the study, the study team will explain everything related to the study in more detail, including the known risks and benefits. You will have the opportunity to ask any questions you may have. You will also be given a very detailed document with more information about the study that you need to sign before you join the study. This is called an Informed Consent Form (ICF).
Every study has criteria that participants have to meet to join a study. These are called the inclusion and exclusion criteria.
To find out if you may be eligible for the PossibILity study, you can answer the questions in this prescreener questionnaire. You can find a study center near you in the Global Trial Locations section.
You will be told about the study in more detail by the team at the study center, and they will also go through the Informed Consent Form (ICF) with you. An ICF is there to make sure you have all the information you need to make the best decision for yourself about participating in a clinical study. The study team will also check whether you meet all the criteria to join the study.
During the PossibILity study, you’ll receive either the investigational drug or placebo. The investigational drug in this study is called galvokimig. The placebo does not contain any medicinally active ingredients and is given the same way as galvokimig. Placebo is used to be able to measure the effect of the investigational drug. The study medication is administered by members of the study team during the study visits.
All study participants are closely monitored by the study staff to ensure their safety.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will not impact the medical care that you receive now or in the future. If you are eligible for the study and choose to participate, you may leave the clinical study at any time and for any reason.
Reimbursement for study-related travel and expenses can be made available. For more information, please speak with a member of the study team during your study visits.
You can bring a care partner with you to help you or keep you company. The study team at the study center is happy to speak with you how to make your study experience as easy as possible.
You can check if you might be eligible for the PossibILity Study with our prescreener. This helps us determine whether you meet the basic criteria of the study. If you meet these criteria, you can contact one of the study centers near you to see if you want to schedule a visit where the study staff will tell you more about the study. At that visit, if you are interested in joining the study, the study team will check if you fit all the specific criteria for the study.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to stop your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled. Study participants are also covered by insurance against any study-related injury by the sponsor.
It can take some time, usually years, before a new treatment is made publicly available after an investigational drug has gone through all the necessary phases of development. That’s because there are rigorous processes to ensure the study drug really does show a benefit, and for the regulatory authorities to check and assess the safety and effectiveness of the potential treatment.
The PossibILity Study is a phase 2 study, which means that more studies will have to follow after this one to find out more about galvokimig before it can be submitted to medical authorities for approval for public use. You can certainly ask your study team and your own doctor about how this process is working.
The study will run at study centers across the globe on behalf of the study sponsor. A sponsor is the person, company, institution, group, or organization that oversees or pays for a clinical study and collects and analyzes the data. UCB is the sponsor of the PossibILity Study. UCB is a global biopharma company with headquarters in Belgium that focuses on immunology and neurology disorders, including skin diseases like atopic dermatitis.
