RPT904-01 Enrolling

Food Allergy Study (68–74 Weeks)


Treatment: Injection Age: 12 - 55 Years


We are looking for males and females aged 12–55 with a food allergy to join a clinical research study testing a potential new food allergy medication.

Who Can Join?
• Allergic to peanut, milk, egg, cashew, and/or walnut
• Positive skin prick test (SPT): ≥3 mm above saline control (ages 18–55) or ≥4 mm (ages 12–17)

What to Expect
• No cost to participate
• About 24 clinic visits with doctors who specialize in food allergies
• Randomized to:
– 48 weeks of study drug, or
– Placebo for 24 weeks, then 24 weeks of study drug
• Reimbursement for study-related expenses may be available

Study Duration:
68–74 weeks


Participating Locations

COUNTRY
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Canada

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: December 15, 2025

Official Title

Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy

ClinicalTrials.gov ID

NCT07220811

Sponsor

RAPT Therapeutics, Inc.

Study Description

  • Brief Summary:

    Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal antibody, in people with food allergy. 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 with documented allergy to at least one of the following foods: peanut, milk, egg, cashew, or walnut will be enrolled. In Part 1 (24 weeks), participants will be randomly assigned to receive RPT904 every 8 or 12 weeks (plus a loading dose at Week 2), or placebo. In Part 2 (24 weeks), participants who received RPT904 will continue on their assigned dosing schedule, and those who previously received placebo will be re-randomized to receive RPT904 either every 8 or 12 weeks (plus a loading dose at Week 26). All participants will attend study visits approximately every 2-6 weeks throughout both Part 1 and Part 2 to maintain blinding, regardless of treatment group or dosing frequency. The study is being conducted at multiple sites. The primary goal is to assess whether RPT904 helps participants tolerate higher amounts of a food allergen without dose-limiting allergic symptoms during a food challenge. The study will also monitor the safety and side effects of RPT904 over time. Each participant is expected to be in the study for about 68 to 74 weeks, including screening, treatment, and follow-up.

  • Condition or Disease:

    Ig-E Mediated Food Allergy

  • Intervention/Treatment:

    Drug: RPT904,Other: Placebo Drug: RPT904,Other: Placebo Drug: RPT904,Other: Placebo
  • Phase:

    PHASE2

  • Ages Eligible for Study:

    12 Years and 55 Years (CHILD,ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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