Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
This study is looking at a new medicine called RPT904 for people aged 12 to 55 who have allergies to common foods like peanuts, milk, eggs, cashews, or walnuts. RPT904 is a long-acting antibody that might reduce allergic reactions. Participants will receive either RPT904 or a dummy medicine (placebo) for over a year. The main goal is to find out if RPT904 helps people tolerate more of their problem food without allergic reactions during a controlled food test. The study will also carefully watch for any side effects. Regular study visits will be needed. Participants would be in the study for about 68 to 74 weeks in total.
At a glance
What is this study about?
This study is a research project looking into a new medicine called RPT904 for people who have food allergies. The main idea behind RPT904 is that it's a special type of antibody, like tiny helpers in your body, designed to block the things that cause allergic reactions. The hope is that by taking RPT904, people with allergies might become less sensitive to certain foods.
The study wants to find out two main things. First, does RPT904 help people become more tolerant to the foods they are allergic to? This means could they eat more of that food without having an allergic reaction? To check this, participants will have carefully supervised food challenges. Second, the study will closely monitor the medicine to make sure it's safe and to understand any side effects it might have. This is a "Phase 2b" study, which means it's one of the earlier stages of testing in humans, following initial safety checks, to see how well the medicine works and find the best dose.
Taking part in a study like this is important because it helps scientists learn more about new treatments for conditions like food allergies. If RPT904 proves to be safe and effective, it could offer a new way to manage food allergies in the future, potentially improving the quality of life for many people.
Key takeaways
- Tests a new medicine (RPT904) for food allergies.
- Aimed at people aged 12 to 55 with specific food allergies.
- Compares RPT904 to a dummy medicine (placebo).
- Checks if RPT904 helps you eat more of your problem food safely.
- Monitors for safety and side effects.
- Participation lasts about 68-74 weeks with regular clinic visits.
Who may be eligible?
To join this study, you need to be aged between 12 and 55 years old.
You must have a confirmed allergy to at least one of these foods: peanuts, milk, eggs, cashews, or walnuts. This allergy will need to be proven through specific tests, including skin prick tests, blood tests for allergy markers (IgE), and a controlled food challenge where you eat a small amount of the food under medical supervision to confirm an allergic reaction.
It's also important that you (or your parent/guardian if you're under 18) can understand what the study involves and agree to take part.
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 between 12 and 55 years old?
- Do you have a confirmed allergy to at least one of these foods: peanut, milk, egg, cashew, or walnut?
- Are you able to attend regular clinic appointments for over a year?
- Are you able to understand and agree to the study procedures (or is your parent/guardian able to)?
- Are you willing to undergo supervised food challenges?
What does participation involve?
If you join this study, you'll be in it for about 68 to 74 weeks, which is roughly a year and a half. During this time, you'll receive either the new medicine, RPT904, or a dummy medicine (called a placebo). For the first 24 weeks, you'll be given either the real medicine or the placebo. After that, if you were on the placebo, you'll switch to the real medicine. The medicine will be given as injections every 8 or 12 weeks, with an extra starting dose at certain points.
You'll need to attend clinic visits every 2 to 6 weeks throughout the entire study to help the study team monitor your health and how you're responding. These visits are important to make sure everyone involved in the study doesn't know who is getting the real medicine and who is getting the placebo. There will also be food tests, where you'll carefully eat tiny amounts of the food you're allergic to, to see how the medicine is working. The study team will be watching closely for any allergic reactions and side effects during these tests and throughout your time in the study.
Potential risks and benefits
Locations (31)
- Arkansas Children'sVerified postcodeLittle Rock, United States· Recruiting
- Sean N. Parker Center for Allergy and Asthma ResearchVerified postcodePalo Alto, United States· Recruiting
- Asthma & Allergy Associates, P.C.Verified postcodeColorado Springs, United States· Recruiting
- National Jewish HealthVerified postcodeDenver, United States· Recruiting
- Children's National HospitalVerified postcodeWashington D.C., United States· Recruiting
- University of South FloridaVerified postcodeTampa, United States· Recruiting
- Children's Healthcare of Atlanta - Center for Advanced PediatricsVerified postcodeAtlanta, United States· Recruiting
- Boston's Children's HospitalVerified postcodeBoston, United States· Recruiting
- University of MichiganVerified postcodeAnn Arbor, United States· Recruiting
- Clinical Research Institute, IncVerified postcodeMinneapolis, United States· Recruiting
- Northwell HealthVerified postcodeGreat Neck, United States· Recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
Common questions
What is RPT904?
RPT904 is a new medicine being tested. It's a type of antibody designed to help reduce allergic reactions in people with food allergies.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the real medicine's effects.
How long does the study last?
Each person will be part of the study for about 68 to 74 weeks, which is roughly a year and a half.
What kind of food allergies are included?
The study includes allergies to peanuts, milk, eggs, cashews, and walnuts.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor the study team will know who is receiving the real medicine (RPT904) or the placebo during the initial part of the study. This is called 'double-blinded'.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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