A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)
This study is called ONWARD2 and is looking at a new medicine called ESK-001 for adults with moderate to severe plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches. The study aims to find out if ESK-001 is safe and effective in improving these skin patches compared to a dummy pill (placebo) and an already approved medicine, Otezla. Participants will take medication by mouth for up to 16 weeks, and researchers will carefully check how their skin improves and if they have any side effects. This is a Phase 3 study, which means it’s one of the final stages of testing before a medicine might become widely available.
At a glance
What is this study about?
This research study, called ONWARD2, is focusing on people who have moderate to severe plaque psoriasis. This is a common skin condition where the body’s immune system mistakenly attacks healthy skin cells, causing them to grow too quickly. This leads to patches of red, scaly skin that can be itchy, sore, and sometimes embarrassing.
The main goal of this study is to test a new medicine, ESK-001. Researchers want to see if this new treatment can make psoriasis patches much better or even clear them up completely. They will compare ESK-001 to a dummy pill (which contains no active medicine, called a placebo) and to Otezla, an existing medicine already used for psoriasis. This comparison helps them understand how well ESK-001 works and if it's better or safer than what's currently available.
Taking part in this study means you would be trying out a potential new treatment. The results will help doctors understand more about how to best treat plaque psoriasis, potentially leading to new options for people affected by this condition in the future.
Key takeaways
- This study is for adults with moderate to severe plaque psoriasis.
- It's testing a new medicine (ESK-001) against an existing one (Otezla) and a dummy pill.
- Participation involves taking medication by mouth for up to 16 weeks.
- Regular clinic visits are needed to monitor your skin and health.
- You'll receive close medical attention throughout the study.
- You have the right to leave the study at any time.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. The study is specifically looking for people who have been diagnosed with plaque psoriasis that is considered moderate to severe.
This means your psoriasis needs to affect a certain amount of your body and be causing significant symptoms. The doctors running the study will assess your psoriasis to make sure it fits these requirements. You shouldn't have other serious health conditions that might interfere with the study medicine or your ability to safely take part.
There might be other specific health checks or medication requirements that the study doctors will discuss with you. It's important to have a full discussion with the research team to confirm if this study is right 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 18 years old or older?
- Do you have a diagnosis of moderate to severe plaque psoriasis?
- Are you generally healthy, apart from your psoriasis?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you join this study, you would be given one of three things to take by mouth for up to 16 weeks: the new medicine ESK-001, Otezla (an existing medicine), or a dummy pill (placebo). You won't know which one you're taking, and neither will the study doctors – this is a common approach in research to make sure the results are fair.
You would need to attend regular appointments at the study clinic. During these visits, doctors and nurses will check your general health, examine your skin to see how your psoriasis is changing, and ask you about any side effects you might be experiencing. They will also take blood samples and ask you to fill out questionnaires about how your psoriasis is affecting your daily life and symptoms like itching.
After the 16 weeks of taking the study medication, there will be follow-up appointments to continue monitoring your health and psoriasis. The exact number of visits and tests will be explained in detail by the study team, but generally, these studies involve regular check-ups to closely monitor participants.
Potential risks and benefits
Locations (9)
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedEstonia
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedLatvia
- —UnverifiedRomania
- —UnverifiedAustria
Common questions
What is plaque psoriasis?
It's a common skin condition where skin cells grow too fast, causing red, scaly patches that can be itchy or sore.
What is a 'placebo'?
A placebo is a dummy pill that looks like the study medicine but contains no active ingredients. It's used to fairly compare real medicine against no treatment.
Will I know if I'm getting the new medicine?
No, neither you nor the doctors will know which treatment you are receiving (ESK-001, Otezla, or placebo). This is to ensure unbiased results.
How long will I be in the study?
You'll take the study medication for up to 16 weeks, with follow-up appointments after that. The total duration will be fully explained by the study team.
What if I feel unwell during the study?
You will have regular contact with the study team, and you should tell them immediately about any new or worsening symptoms so they can provide care and advice.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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