Who can take part in the RAPT Therapeutics eczema RAPT Therapeutics is conducting a clinical trial in eczema. If you have eczema, you may be able to take part if you:
This is not a full list of requirements.
About the eczema clinical trialRAPT Therapeutics is conducting a randomized placebo-controlled trial that is looking at how safe and effective an investigational medication may be in improving eczema symptoms. Different doses of the investigational medication will be used during the trial.
A ‘randomized placebo-controlled trial’ means that you would be randomly assigned to a group within the trial. In this trial, you might receive the investigational medication or you might receive a placebo.
An ‘investigational medication’ is a medication that is being tested in a clinical trial. It hasn’t been approved for use in eczema and researchers will use the trial to learn how safe it is, and how well it works to treat eczema symptoms. Investigational medications are tested extensively before being used in clinical trials and they are researched in several trials before being approved for use. The investigational medication in this trial has already been tested in an earlier clinical trial. RAPT Therapeutics has completed a randomized, placebo-controlled, Phase 1b trial in patients with atopic dermatitis, in which RPT193 as monotherapy demonstrated clinically meaningful improvement in several key exploratory endpoints after 4 weeks of treatment with further improvement for two weeks after completion of treatment. In addition, RPT193 was well tolerated with only mild or moderate adverse events.
A ‘placebo’ (or ‘sugar pill’) is an inactive substance that has no effect. It will look the same as the investigational medication and will be given in the same way.
In this trial there are 4 different groups: 3 groups will receive the investigational medication (at 3 different doses) and one group will receive the placebo. This means that you have a 1 in 4 chance of receiving the placebo.
This trial is ‘double-blind’. This means that neither you nor the study doctors will know which group you are in or whether you are receiving the investigational medication or a placebo.
The exact cause of eczema isn’t fully understood but it is known that people with eczema tend to have an overactive immune system. This can result in their immune systems overreacting to irritants and allergens, leading to redness and inflammation.1
The investigational medication used in this trial is a once daily oral drug called RPT193. It works by targeting some of the cells involved in our immune response that research has linked to the inflammation that drives eczema. It is hoped that the medication will help to reduce the immune response, resulting in less eczema inflammation.
Eczema clinical trial available locationsThis eczema clinical trial is taking place in over 50 locations across the US. If you don’t live close to a study site, but you want to take part in the trial, then some travel-related costs may be reimbursed. Further details will be provided if you are selected for the trial.
The trial is taking place at the locations shown on the map below.
What’s involved in the eczema clinical trial?If you choose to participate in the RAPT Therapeutics eczema clinical trial, participation will last around 6–7 months (a maximum of 29 weeks). Around 250 people will take part in the trial.
The trial has three parts: A screening period, a treatment period and a follow-up period. In each period there will be some visits required to see the trial doctor. These visits will include answering some questions and having some tests to check your eczema symptoms.
Screening period: During this time you will have 1 visit where you will answer some questions and have some tests to make sure that the trial is right for you. This could take place up to 35 days before the treatment period starts.
Treatment period: This period is where you will receive the trial medication (the investigational medication or placebo). This period lasts 16 weeks and you will also have some tests and answer some questions. You will have 6 visits during this time. You will take the trial medication as a tablet on a daily basis at home.
Follow-up period: During this 8-week period you will continue to be checked by the study doctor, you will answer some questions and have some tests to check on your eczema symptoms. You will have 3 visits during this time.
Across the three periods there will be 10 clinic visits required in total.
Why should I take partin this eczema clinical trial?While there are approved eczema treatments currently available, these treatments are not right for everyone so there is a need for new treatments in order to help as many people as possible with eczema get the treatment they need. It’s also important to find more treatments which are easy to administer, such as tablets.
All new treatments need to be tested in clinical trials before they can be approved for use. By taking part in an eczema clinical trial or study, you are helping to find new future treatments for eczema.
