Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A multicentre, randomised, double-blind, placebo-controlled, 12-week parallel-group trial to evaluate the efficacy and safety of oral BP1.7881 in adult patients with moderate-to-severe atopic dermatitis

This research study is looking into a new tablet treatment, called BP1.7881, for adults who have moderate to severe eczema (atopic dermatitis). We want to find out if this new tablet is safe and if it helps improve the symptoms of eczema, like redness, dryness, and itching. Participants will take either the new tablet or a dummy tablet (placebo) every day for 12 weeks. Neither the patient nor their doctor will know which tablet they are taking during the study. We will be carefully checking how their eczema symptoms change over this time to see if the new medicine works better than the dummy tablet.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bioprojet Pharma, Bioprojet Pharma

Enrolment target

Start

31 May 2023

Atopic dermatitis

What is this study about?

This study is about finding better ways to treat moderate to severe eczema, which is also known as atopic dermatitis. Eczema is a common skin condition that can cause red, itchy, and dry patches on the skin, and it can sometimes be very uncomfortable and affect daily life. Current treatments can help, but researchers are always looking for new options that might work better or have fewer side effects.

In this particular study, scientists are testing a new oral medication called BP1.7881. "Oral" just means it's a tablet you take by mouth. The main goal is to see if this new tablet can significantly improve eczema symptoms in adults over a 12-week period. They will be comparing it to a "placebo," which is a dummy tablet that looks exactly like the real medicine but contains no active ingredients. This helps researchers understand if any improvements are genuinely due to the new medicine or just other factors.

This is a "Phase II" study, which means it's an earlier stage of research. It's designed to explore if the new medicine is effective and safe enough to be tested in larger studies in the future. The results from this study will help us understand if BP1.7881 has the potential to become a new treatment option for people living with eczema.

Key takeaways

This study is for adults with moderate to severe eczema.
It's testing a new tablet, BP1.7881, against a dummy tablet (placebo).
The treatment period lasts 12 weeks.
The main goal is to see if the new tablet improves eczema symptoms and itching.
Participation involves regular clinic visits for assessments.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, who have moderate to severe eczema (atopic dermatitis). Both men and women can take part in this research.

To be considered for the study, your eczema must be affecting you quite a bit – it can't be too mild. The study team will check your current health and medical history to make sure taking part is safe for you and that you meet all the specific requirements of the study.

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 moderate to severe eczema?
Are you able to visit a clinic regularly for appointments?
Are you willing to take a study tablet daily for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would last for about 12 weeks, plus some initial screening and follow-up. You'd need to visit the clinic a few times for check-ups with the study doctors and nurses. At these visits, they would do physical exams, take blood samples, and ask you questions about your eczema symptoms and how you're feeling.

You would receive either the new medicine (BP1.7881) or a matching dummy tablet called a placebo. You would take this tablet daily. You, your family, and the study team wouldn't know whether you're taking the active medicine or the placebo. This is to make sure the results are as fair and unbiased as possible. Your eczema symptoms, especially itching, would be regularly assessed using special scales to see how they change over time.

Potential risks and benefits

Taking part in a clinical trial has both possible benefits and risks. You might benefit from the new treatment if you receive the active medicine and it works for your eczema. You'll also receive careful monitoring from medical professionals throughout the study. However, there's no guarantee that the new medicine will help you, or that you won't experience side effects, just like with any medicine. Possible risks could include side effects from the medication or discomfort from clinic visits, such as blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Poland
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Unverified
France

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical name for eczema, a common skin condition that causes dry, itchy, and inflamed patches on the skin.

What does 'placebo' mean?

A placebo is a dummy tablet that looks exactly like the study medicine but contains no active ingredients. It helps researchers see if the real medicine is truly working.

Will I know if I'm taking the real medicine?

No, during the study, neither you nor your doctor will know if you are taking the study medicine or the placebo. This is to keep the study fair and accurate.

How long will the treatment last?

The active treatment period for this study is 12 weeks. There will also be some initial screening visits and follow-up appointments.

What is the main thing the study is looking for?

The main thing is to see how much improvement there is in your eczema symptoms, like redness and dryness, after 12 weeks of taking the study medication or the placebo.