RPT904 for Food Allergy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a new treatment, RPT904, can help people with food allergies tolerate more of their allergen without severe reactions. RPT904 is a long-acting antibody administered through injections, potentially requiring fewer doses over time. The trial will assess if participants can consume more of their allergen, such as peanuts or milk, without significant allergic symptoms. Individuals with a documented allergy to peanuts, milk, eggs, cashews, or walnuts who experience allergic reactions during food challenges might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in allergy treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers. If you are currently using these, you would need to discontinue them to participate in the study.
Is there any evidence suggesting that RPT904 is likely to be safe for humans?
Research has shown that RPT904, a type of medication, is generally well-tolerated. This treatment aims to help people with food allergies by reducing their allergic reactions. In earlier studies, participants required injections only every 8 to 12 weeks, less frequently than some other treatments.
Although detailed safety data is not provided here, the advancement of this treatment to this stage of trials suggests it has demonstrated a reasonable safety profile so far. Researchers will continue to monitor for any side effects during this study to ensure it remains safe for participants.12345Why do researchers think this study treatment might be promising for food allergy?
Unlike the standard of care for food allergies, which often involve strict allergen avoidance and emergency treatments like epinephrine, RPT904 offers a proactive approach. RPT904 is a subcutaneous injection that targets the underlying immune response by modulating IgE levels, which are key players in allergic reactions. Researchers are excited because this treatment has the potential to reduce the frequency and severity of allergic reactions, offering longer-lasting protection with dosing every 8 to 12 weeks. This could significantly improve the quality of life for individuals with food allergies by reducing their need for constant vigilance and emergency interventions.
What evidence suggests that RPT904 might be an effective treatment for food allergy?
Previous studies have shown promising results for RPT904 in conditions related to IgE, such as chronic spontaneous urticaria. This trial will evaluate RPT904 for food allergies, with participants receiving RPT904 every 8 weeks, every 12 weeks, or a placebo. The investigational treatment might help people with food allergies consume more of the foods they are allergic to without severe reactions. Compared to omalizumab, another treatment, RPT904 has demonstrated better results in reducing allergy symptoms. As a long-lasting antibody, RPT904 could require fewer doses over time, offering more convenience for patients. These early findings suggest that RPT904 could effectively manage food allergies.23678
Are You a Good Fit for This Trial?
This trial is for people aged 12-55 with a confirmed allergy to peanuts, milk, eggs, cashews, or walnuts. Participants must have an IgE-mediated food allergy and be able to attend regular study visits over the course of about 1.5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive RPT904 or placebo every 8 or 12 weeks with a loading dose at Week 2
Treatment Part 2
Participants continue RPT904 or switch from placebo to RPT904 every 8 or 12 weeks with a loading dose at Week 26
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RPT904
Trial Overview
The trial tests RPT904, a new anti-IgE antibody designed for long-term relief from food allergies. It's compared against a placebo in two parts: initial treatment and follow-up reassignment. The goal is to see if patients can tolerate more allergens without severe reactions.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
RPT904 every 8 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) within the Q8W cohort will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 8 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding.
RPT904 every 12 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 12 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding.
Placebo subcutaneous injection on schedules matching both the Q8W and Q12W arms in Part 1 (24 weeks); RPT904 every 8 or 12 weeks with a loading dose at Week 26 on schedules matching both the Q8W and Q12W arms Part 2 (24 weeks), with matching placebo at intervening visits to maintain blinding.
Find a Clinic Near You
Who Is Running the Clinical Trial?
RAPT Therapeutics, Inc.
Lead Sponsor
Citations
RAPT Therapeutics Initiates prestIgE Phase 2b Clinical ...
Trial initiation in food allergy follows promising results in Phase 2 trial in chronic spontaneous urticaria, another IgE-driven condition ...
Positive Topline, Phase 2 Data Announced for RPT904 ...
RPT904 may help to provide longer-lasting pharmacokinetic and pharmacodynamic effects compared to omalizumab. It is also being developed for the ...
3.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/rapt-therapeutics-starts-phase-2b-trial-for-food-allergies/Rapt Therapeutics Starts Phase 2b Trial for Food Allergies
Regulators have increasingly favored functionally meaningful endpoints in food allergy; the prespecified challenge threshold and multi‑allergen ...
4.
seekingalpha.com
seekingalpha.com/article/4831254-rapt-therapeutics-inc-rapt-discusses-top-line-phase-ii-results-for-rptminus-904-in-chronicRAPT Therapeutics, Inc. (RAPT) Discusses Top Line ...
Both RPT904 dosing arms showed numerically superior efficacy to omalizumab on UAS7, the primary endpoint as well as a key secondary endpoint ...
Phase 2b Study of RPT904 as Monotherapy in Participants ...
The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic ...
RAPT Therapeutics Announces FDA Clearance of IND ...
The Phase 2b trial, named “prestIgE”, is designed to assess the efficacy and safety of RPT904 monotherapy in participants with IgE-mediated food ...
7.
allergicliving.com
allergicliving.com/2025/04/11/xolair-rival-aims-for-food-allergy-dosing-of-every-2-to-3-months/Xolair Rival Aims for Food Allergy Dosing of Every 2 to 3 ...
Rapt's anti-IgE therapy RPT904 may prove a rival to Xolair for multiple #foodallergies. In an early study, only required shots 2–3 months.
Phase 2b Study of RPT904 as Monotherapy in Participants ...
RPT904 is a long-acting antibody that may allow for dosing every 8 to 12 weeks. Approximately 100 participants between the ages of 12 and 55 ...
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