What is prestIgE?
prestIgE is a Phase 2 clinical trial for people who are allergic to at least one of the following foods: peanut, milk, egg, cashew, or walnut (for milk and egg, unable to tolerate baked forms of the food). It is studying the efficacy (how well It works) and safety of an investigational medicine known as ozureprubart (pronounced “oh-zoo-rep-ru-bart,” previously known as RPT904 or JYB1904).*† prestIgE will enroll about 100 people at trial sites worldwide. There is no cost to participate.
What is ozureprubart?
Ozureprubart is designed to be a long-lasting medication that blocks immunoglobulin E (IgE), a protein in your body that contributes to the abnormal immune response to food. This may help prevent or reduce allergic reactions when eating certain foods. In a study in healthy volunteers, ozureprubart stayed in the body longer than omalizumab (Xolair®‡). Because of this, ozureprubart has the potential to be dosed every 8 to 12 weeks vs every 2 or 4 weeks for omalizumab. Ozureprubart also has the potential to treat people who cannot be treated with omalizumab (eg, those with higher IgE or body weight).
Who can participate?
- People between the ages of 12 and 55 (inclusive) at screening
- Confirmed allergy to at least one of the following foods: peanut, milk, egg, cashew, walnut
- Willing to avoid pregnancy/breastfeeding (self or partner)
- CANNOT have any of the following:
- Clinically significant laboratory abnormalities
- Uncontrolled or severe asthma
- Recent (within the past 6 months) immunomodulatory treatments (eg omalizumab, dupilumab, other biologics)
- Any oral, sublingual (under the tongue), or epicutaneous (on the skin) immunotherapy to study foods within the past 6 months
- Oral, intravenous (IV), or intramuscular (IM) steroids for more than 2 days within 30 days of screening (other than for asthma)
- A chronic disease requiring therapy (asthma/wheezing, atopic dermatitis/eczema, or rhinitis/hay fever are OK)
Additional criteria apply. Clinical trial site staff will work with potential participants to make sure they are eligible.
What is involved in participation?
Participants in prestIgE will be part of a screening period to make sure they are eligible, two 24-week treatment periods, and a 16-week follow-up period. Participation is voluntary and people can change their mind at any time. During the first 24-week treatment period, participants will be randomly assigned to receive ozureprubart every 8 weeks§, ozureprubart every 12 weeks§, or placebo (an inactive substance that looks just like ozureprubart). Participants cannot choose which group they will be in, and neither participants nor the trial staff will know which group they are assigned to. After the first 24-week treatment period (Part 1), everyone who was receiving placebo will receive ozureprubart (Part 2).
After completing the screening process, participants will have regular visits to the trial site over approximately 15 months.
During these visits, trial staff will:
- Conduct a double-blind placebo-controlled food challenge at screening, Week 24, and Week 48 (note the food challenge can be to just one food allergen and placebo, even for people with multiple allergies)
- Ask health-related questions and do a physical exam
- Draw blood
- Do skin prick tests
- Do breathing tests
- Administer ozureprubart or placebo as an injection just under the skin (note in Part 2 of the study all paticipants receive ozureprubart)
¶Plus a loading dose at Week 26.