A phase 2B, multicenter, randomized, double-blind, placebo-controlled, dose-finding, efficacy and safety study of HRO350 in subjects with mild-to-moderate psoriasis (the ‘HeROPA’ study)
This research study, called 'HeROPA', is looking into a new treatment for psoriasis, called HRO350. Psoriasis is a skin condition that causes red, scaly patches. The study aims to find out how effective HRO350 is at improving these symptoms and if it's safe for people to use. Around half of the participants will receive doses of HRO350, while the other half will receive a 'dummy' treatment without active medicine to allow for a fair comparison. This is a common way to test new medicines. Participants will be monitored over 26 weeks, and researchers will check for improvements in their psoriasis and any side effects. It's open to adults aged 18 and older with mild to moderate psoriasis.
At a glance
What is this study about?
This study is a research project aiming to understand more about a new treatment for psoriasis, called HRO350. Psoriasis is a common skin condition where skin cells grow too quickly, leading to red, flaky, crusty patches covered with silvery scales. These patches can be itchy, dry, and sore.
Researchers want to see if HRO350 can help improve these psoriasis symptoms and make a real difference to people’s lives. They are also carefully checking to make sure it's safe to use. This new treatment is being compared to a 'dummy' treatment (a placebo), which looks exactly like the real medicine but contains no active ingredients. This helps researchers know for sure if any improvements are due to HRO350 itself, rather than other factors.
The study is called 'HeROPA' and will involve many different healthcare centres. Participants will be monitored over about six months (26 weeks) to track how their psoriasis changes and if they experience any side effects. This type of study, called a Phase 2B trial, means it's an important step in developing new medicines, looking more closely at how well a treatment works and the best dose to use, after initial safety tests.
Key takeaways
- This study tests a new psoriasis treatment called HRO350.
- It's for adults (18+) with mild to moderate psoriasis.
- Participants will receive either HRO350 or a dummy treatment.
- The study lasts about 26 weeks with regular check-ups.
- It aims to see if HRO350 is effective and safe.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults who have psoriasis. You would need to be at least 18 years old to take part. There is no upper age limit, meaning older adults can also participate.
Both men and women are welcome to join this study. The psoriasis you have should be considered mild to moderate, meaning it's not severe, but still bothersome enough that you might be looking for new treatment options.
Detailed medical checks will be done by the study team to make sure it's safe and appropriate for you to join. This will involve looking at your overall health and any other medications you might be taking.
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 mild to moderate psoriasis?
- Are you able to attend regular clinic visits for about six months?
- Are you willing to potentially receive a dummy treatment?
What does participation involve?
If you decide to take part in this study, you would first have screening appointments to check if you're a good fit. If you qualify, you would be given either the new study medication (HRO350) or a dummy treatment, which looks the same. Neither you nor your study doctor would know which one you are receiving – this is to keep the study fair and unbiased. The study medicine comes in capsule form.
Throughout the study, you would attend regular visits at a clinic over about 26 weeks (roughly six months). During these visits, the study team would monitor your psoriasis, checking for any changes in the affected areas of your skin. They would also ask you questions about your symptoms, your quality of life, and how you generally feel. You would have blood tests and other checks to make sure the treatment is safe.
Towards the end of the 26 weeks, or if you needed to stop the study treatment early, you would have a final check-up. The study team would be there to support you and answer any questions throughout your participation.
Potential risks and benefits
Locations (4)
- —UnverifiedFinland
- —UnverifiedGermany
- —UnverifiedNorway
- —UnverifiedPoland
Common questions
What is HRO350?
HRO350 is a new medication being tested to see if it can help improve symptoms of psoriasis.
What is a 'dummy' treatment?
A 'dummy' treatment, or placebo, looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the new treatment fairly.
How long will I be in the study?
The study involves regular visits over approximately 26 weeks, which is about six months.
Can I stop participating at any time?
Yes, you are free to leave the study at any point, and your decision won't affect your future medical care.
Will I know if I'm getting the real medicine?
No, during the study, neither you nor your doctor will know if you are receiving HRO350 or the dummy treatment. This is to keep the study fair.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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