Safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous and subcutaneous multiple rising doses of BI 765250 versus placebo in trial participants with moderate to severe plaque psoriasis (double-blind, randomised, placebo-controlled, parallel-group design)
This research study is testing a new medication, BI 765250, for adults who have moderate to severe plaque psoriasis. The main goal is to understand how safe the new drug is and how well people tolerate it, meaning if they experience many side effects. Researchers will also study how the medicine moves through the body and what effects it has on psoriasis. Participants will either receive the new medicine through a drip or an injection under the skin, or a placebo (a dummy treatment with no active drug). This helps researchers compare the real medication's effects. It's a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the active drug or the placebo, to keep the results fair and unbiased.
At a glance
What is this study about?
Are you living with moderate to severe plaque psoriasis? Researchers are currently looking for volunteers to take part in a study testing a new potential medicine called BI 765250. Plaque psoriasis is a common skin condition that causes red, scaly patches on the skin, and sometimes current treatments don't work for everyone. This study aims to find out if this new medicine could be another option for people like you.
The main purpose of this study is to carefully check the safety of BI 765250. This means doctors will be looking closely for any side effects and how well people tolerate the new medicine. They also want to understand how the medicine works in your body – how much is absorbed, how long it stays there, and how it affects your psoriasis. This is called a 'Phase I' study, which is an early stage of clinical research where new medicines are first tested in people, often in smaller groups, to get initial information on safety and dosing.
To make sure the results are as clear and reliable as possible, the study uses a 'double-blind' approach. This means that neither you nor the study doctors will know whether you are receiving the new medicine or a placebo (a treatment that looks exactly the same but contains no active drug). This helps to ensure that any improvements or side effects observed are genuinely due to the medicine being tested, and not due to expectations. Results from studies like this are crucial for developing new and better treatments for plaque psoriasis.
Key takeaways
- This study is for adults with moderate to severe plaque psoriasis.
- It's testing a new medicine, BI 765250, for safety and how it works.
- Participants will receive either the new medicine or a placebo.
- Neither you nor your doctor will know which treatment you are getting.
- You'll have regular clinic visits for monitoring and assessments.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be 18 years old or older. The study is open to both men and women.
Because no specific details were provided beyond age and sex, typically, studies like this look for people who have been diagnosed with moderate to severe plaque psoriasis. This means your psoriasis is more than just a few small patches and doctors would generally agree it needs treatment.
There will also be other health requirements reviewed by the research team. For example, they'll need to check your general health, make sure you don't have certain other medical conditions, and that any medications you're currently taking won't interfere with the new drug being tested. All these checks are done to ensure your safety throughout the study.
- Are you 18 years old or older?
- Do you have plaque psoriasis that is considered moderate to severe?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive a placebo?
- Are you comfortable with injections or intravenous infusions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to participate, you will receive either the new study medicine, BI 765250, or a placebo. The medicine will be given either through a drip into your arm (intravenous) or as an injection just under your skin (subcutaneous). You'll have multiple doses over a period of time, as the study is designed to look at "multiple rising doses." This means the amount of medication might gradually increase within safe limits.
Your participation will involve regular visits to the study clinic. During these visits, the research team will closely monitor your health, check for any side effects, and perform assessments related to your psoriasis and general well-being. This will include physical exams, blood tests, and perhaps skin assessments. You will have follow-up visits after your last dose to ensure everything is okay. The total duration of the study has not been specified but Phase I studies often last from several weeks to a few months, including follow-up.
Potential risks and benefits
Locations (2)
- —Bulgaria
- —Romania
Common questions
What is plaque psoriasis?
Plaque psoriasis is a common, long-lasting skin condition where skin cells grow too quickly, leading to red, scaly, and sometimes itchy patches on the skin.
What does 'double-blind' mean in a study?
It means neither you nor your study doctor will know if you are receiving the active new medicine or a placebo (a dummy treatment). This helps make the study results fair.
What is a 'placebo'?
A placebo is a substance or treatment that looks exactly like the real medicine but has no active drug in it. It's used for comparison in studies.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related medication and assessments are usually provided free of charge.
How long will I be in the study?
The exact length isn't specified here, but studies like this usually involve multiple visits over several weeks or a few months, including follow-up after your last dose.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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