This trial is closed for enrollment.

Participate in a clinical study on psoriasis?

  • Gender Both
  • Age from 18 up to and including 70

The purpose of this research study is to determine which doses of the study drug, EDP1815, are safe and effective in the treatment of plaque psoriasis/psoriasis vulgaris.

 

Who can take part?

You may be eligible for this study if:

  • you are between 18 and 70 years of age;
  • you have had a diagnosis of plaque psoriasis/psoriasis vulgaris for at least 6 months.

There are other specific requirements for participation, which your study doctor will discuss with you.

 

What happens if you decide to participate?

If you decide to participate in this study, you will be asked to make a total of 11 scheduled visits to the study clinic over the next six months; Your study doctor or nurse will advise you in advance how long each visit will take, but please expect each visit to take approximately 2–3 hours. It is possible that you could be requested to come to the study clinic for an extra visit(s) if considered necessary by your study doctor.

 

Important information:

  • The study will be performed at no cost to you.
  • You will be monitored closely throughout the study.
  • You may experience an improvement in your psoriasis symptoms, but this cannot be guaranteed.
  • It may be that your participation in this study does not result in any benefit to your own health. However, you will contribute to increasing knowledge about the treatment of plaque psoriasis. The knowledge gained from this study may contribute to medical progress and thereby benefit other people’s health.
  • You will receive a stipend as reimbursement for your participation in this study, which your study doctor will be able to explain to you in more detail.

 

How to apply

If you would like to learn more about the study and whether you may be able to take part, please register on this website and answer the subsequent questions. If you are eligible, one of the participating clinics will contact you to schedule an appointment and will also be happy to answer any questions you may have.

The purpose of this research study is to determine whether and which doses of the study drug, EDP1815, are safe and effective in the treatment of plaque psoriasis compared with a placebo.

EDP1815 is an experimental new medicine, referred to as the study drug. It is not yet approved by the European Medicines Agency (EMA) in Europe or the US Food and Drug Administration (FDA) in America. EDP1815 is being tested to treat psoriasis and other diseases linked to problems with the immune system that cause inflammation. The study drug is a single type of bacteria, called Prevotella histicola. It is naturally found in some parts of the body, like the nose, mouth, and gut of some people. Some types of bacteria that live in our gut are able to interact with our immune system, causing effects in other parts of the body, not just in the gut. We are testing whether these ”good bacteria” in the study drug will work by interacting with and changing the immune response to reduce the symptoms of inflammatory diseases, like psoriasis.

EDP1815 has been tested previously in animals and approximately 50 people, and the results show the compound is generally safe and well tolerated.

This study has been designed by Evelo Biosciences Inc. and is being performed by doctors at various study clinics. Evelo Biosciences Inc. is paying for the costs of this study.

What is a clinical study?

  • A clinical study is a scientific study on how a new or existing medicine, product, procedure, or treatment works in people.
  • Through clinical studies, doctors can find new and better ways to prevent, detect, diagnose, control, and treat illnesses.
  • All clinical studies are carefully monitored and regulated to protect participant well-being.
  • Participating in a clinical study is completely voluntary and will not affect the normal standard of care you receive.

 

What happens if you decide to participate?

If you decide to participate in this study, you will be asked to make a total of 11 scheduled visits to the study clinic over the next six months.

 

The study is divided into three parts: the screening period, the treatment period, and the follow-up visit.

  • The screening period: the screening period can last up to 4 weeks. Some people may require more than one visit to the clinic to complete the screening procedures. Tests and procedures will be performed to see if you meet the criteria to participate in the study.
  • The study treatment period: this is the period when you take the study drug or placebo (a dummy treatment that looks the same as the active treatment, but contains no active ingredients). During this time (a total of 16 weeks) you will be evaluated regularly at the study center during 9 planned study visits. Your study doctor or nurse will advise you in advance how long each visit is estimated to take. It is possible that you could be requested to come to the study clinic for an extra visit(s) if considered necessary by your study doctor.
  • Follow-up visit: after you have been off of the study drug for 4 weeks, you will return for a safety check-up with your study doctor.

 

What happens when you come for study visits?

During the study, the following tests and procedures will be performed, although not every test will be performed at every visit.

If you have any questions about any of these tests and procedures, ask your study doctor and/or study staff at any time.

  • ECG: electrocardiograms (ECGs) will be performed to check the health of your heart. An ECG is a test that measures the electrical activity of your heart.
  • Measurement of your blood pressure, heart rate, and weight.
  • Blood tests: you will be asked to give blood to assess your general health and to assess the level of the study drug in your blood.
  • Urine test: a urine sample will be collected to assess your general health.
  • You will be asked to fill out a 7-day stool (bowel movement) diary.
  • The study doctor will assess how much of your body is affected by your psoriasis using various scoring systems. This is a painless procedure; however, you will need to undress for this assessment.
  • You will also have the option to agree to a skin biopsy, which will be collected at the start and the end of the study.

What do I need to know about this study?

  • Approximately 225 subjects are expected to be included in this study across North America, the EU, and the UK.
  • Participation is voluntary, and you can also decide NOT to participate. Before you decide whether or not you want to participate in this study, you will be given an explanation about what the study involves.
  • You will have no choice in deciding what treatment you will receive in this study. You will be assigned the study drug or a placebo at random (flip of a coin).
  • The study will be performed at no cost to you.
  • You will be monitored closely throughout the study.
  • It is essential that you attend all the study appointments and follow study instructions.
  • You can withdraw from the study at any time and for any reason. This will not affect the standard of care you receive.
  • You can talk to the study team at any time about any questions or concerns you may have.
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