A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study to Evaluate the Efficacy and Safety of ESK-001 in Patients with Moderate to Severe Plaque Psoriasis (ONWARD1)
This research study, called ONWARD1, is looking at a new tablet medicine, ESK-001, for adults who have moderate to severe plaque psoriasis. We want to find out if ESK-001 is better than a dummy pill (placebo) and how it compares to an existing psoriasis medicine called Otezla. Participants will take one of these medicines by mouth for 16 weeks. The main goal is to see if ESK-001 can clear up psoriasis patches and reduce how much they cover the body. We'll also check for any side effects and how the medicine affects a person's quality of life. This is a Phase 3 study, which means it’s one of the final steps before a new medicine might become widely available.
At a glance
What is this study about?
If you have moderate to severe plaque psoriasis, you might be interested in a new research study called ONWARD1. This study is testing a new tablet medicine called ESK-001. Psoriasis is a long-term skin condition where skin cells grow too quickly, leading to red, scaly, and sometimes itchy patches. Moderate to severe means the psoriasis covers a noticeable amount of your body and can significantly affect your daily life.
The main purpose of this study is to see if ESK-001 can help improve your psoriasis symptoms. We want to know if it can clear up your skin more effectively than a dummy pill (called a placebo) and how it compares to a medicine that doctors already use for psoriasis, called Otezla. By comparing these treatments, researchers can get a clear picture of how well ESK-001 works and if it's a safe option for people with psoriasis.
Taking part would mean you would take a tablet every day for 16 weeks. You wouldn't know if you're getting ESK-001, Otezla, or the placebo – this is called a 'double-blind' study and it helps make sure the results are fair and unbiased. Researchers will regularly check your skin, ask about your symptoms (like itching) and how the condition affects your daily life to understand the medicine's effects. This kind of research is really important for developing new and better ways to treat conditions like psoriasis.
Key takeaways
- This study is testing a new tablet for moderate to severe plaque psoriasis.
- It compares the new medicine (ESK-001) to Otezla and a dummy pill.
- Participation involves taking a tablet daily for 16 weeks and clinic visits.
- The goal is to see if the new medicine clears skin and is safe.
- Both men and women aged 18 and over can potentially take part if eligible.
Who may be eligible?
To join this study, we're looking for adults who are 18 years old or older. Both men and women can take part.
You must have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis is noticeable and affects a significant area of your body. The research team will do some checks to make sure your psoriasis fits the study's specific criteria.
There will be other health checks and questions to ensure the study is suitable and safe for you. For example, they'll need to make sure you don't have certain other health conditions or aren't taking specific medications that could interfere with the study medicine.
- Are you 18 years old or older?
- Do you have a diagnosis of moderate to severe plaque psoriasis?
- Are you able to take medicines by mouth (tablets)?
- Are you able to attend regular clinic appointments for 16 weeks? (Specific dates and frequency would be discussed by the clinic)
- Are you willing to potentially receive either the new medicine, Otezla, or a placebo?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would be involved for a total of 16 weeks. During this time, you would visit the study clinic regularly. At these visits, doctors and nurses will assess your psoriasis, check your general health, and ask you about any symptoms or side effects you might be experiencing. You will receive either the investigational medicine ESK-001, the existing medicine Otezla, or a placebo (dummy pill), all in tablet form, to take by mouth throughout the 16 weeks.
Assessments would include examinations of your skin to measure how much your psoriasis has improved. You might also be asked to fill out questionnaires about how your psoriasis affects your daily life and any itching you experience. After the 16 weeks of treatment, there will likely be a final follow-up visit to ensure your well-being. The study team will explain all visits and tests in detail.
Potential risks and benefits
Locations (6)
- —Bulgaria
- —Belgium
- —Portugal
- —Poland
- —Czechia
- —Germany
Common questions
What is 'plaque psoriasis'?
Plaque psoriasis is a common skin condition that causes red, flaky, crusty patches covered with silvery scales. These patches can be itchy and sometimes painful.
What does 'moderate to severe' mean for my psoriasis?
It means your psoriasis covers a significant area of your body, or is particularly troublesome, and likely affects your quality of life.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand the true effect of the medicine being tested.
What is the study drug ESK-001?
ESK-001 is a new medicine being tested as a tablet for people with psoriasis. It's an 'investigational' medicine, meaning it's not yet approved for general use.
How long will I be involved in the study?
The main treatment period for this study is 16 weeks, with some follow-up appointments after that.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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