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New shot could let food allergy sufferers eat peanuts and milk safely

NCT ID NCT07220811

Disease control Sponsor: RAPT Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This study tests a new drug called RPT904 in about 100 people aged 12 to 55 who are allergic to foods like peanut, milk, egg, cashew, or walnut. RPT904 is a long-acting antibody that blocks allergic reactions and may only need to be given every 8 to 12 weeks. The goal is to see if it helps participants eat a larger amount of their trigger food without having a serious allergic reaction.

Why investors are watching

RAPT Therapeutics is running a Phase 2b trial of RPT904, a long-acting anti-IgE antibody for food allergies, in 100 people aged 12 to 55. For a micro-cap company with few other products, this readout is a major value driver. The trial tests whether RPT904 lets patients eat more peanut, milk, egg, cashew, or walnut without allergic symptoms, with dosing every 8 to 12 weeks.

If it works: A positive result could show RPT904 works and lasts longer between doses than current treatments. That might support moving the drug into later-stage trials and give RAPT a credible product in a large allergy market.

If it fails: Phase 2b trials often fail to meet their primary endpoint, and this one is no exception. A miss or delay could hurt RAPT's prospects, since the company's value depends heavily on this drug's success.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable. * Male or female, 12 to less than 56 years of age at screening. * Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or walnut, as confirmed by the following criteria: * a. For participants aged 12 to \<18 years: * i. Allergic to peanut: participant must meet all criteria below: * 1\. Positive SPT (≥4 mm wheal greater than saline control) to peanut. * 2\. Positive peanut IgE (≥6 kUA/L) at screening or within 3 months of screening. * 3\. Positive blinded oral food challenge (OFC) to peanut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut protein. * ii. Allergic to milk or egg: unable to tolerate both cooked and uncooked forms: * 1\. Positive SPT (≥4 mm wheal greater than saline control) to the specific food. * 2\. Positive food-specific IgE (≥6 kUA/L) at screening or within 3 months of screening. * 3\. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein. * iii. Allergic to cashew: participant must meet all criteria below: * 1\. Positive SPT (≥4 mm wheal greater than saline control) to cashew. OR * 2\. Positive cashew IgE (≥6 kUA/L) at screening or within 3 months of screening. AND * 3\. Positive blinded OFC to cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of cashew protein. * iv. Allergic to walnut: participant must meet all criteria below: * 1\. Positive SPT (≥4 mm wheal greater than saline control) to walnut. OR * 2\. Positive walnut IgE (≥6 kUA/L) at screening or within 3 months of screening AND * 3\. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of walnut protein. * b. For participants aged 18 to \<56 years: * i. Allergic to peanut or cashew: participant must meet all of the following criteria: * 1\. Positive SPT (≥3 mm wheal greater than saline control) to peanut or cashew. * 2\. Positive peanut or cashew IgE (≥0.35 kUA/L) at screening or within 3 months of screening. * 3\. Positive blinded OFC to peanut or cashew during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤100 mg (ie, cumulative dose of ≤144 mg) of peanut or cashew protein. * ii. Allergic to milk or egg: participant must meet all of the following criteria: * 1\. Positive SPT (≥3 mm wheal greater than saline control) to the specific food. * 2\. Positive food-specific IgE (≥0.35 kUA/L) at screening or within 3 months of screening. * 3\. Positive blinded OFC to the specific food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie, cumulative dose of ≤444 mg) of food protein. * iii. Allergic to walnut: participant must meet all of the following criteria: * 1\. Positive SPT (≥3 mm wheal greater than saline control) to walnut. * 2\. Positive walnut IgE (≥0.35 kUA/L) at screening or within 3 months of screening. * 3\. Positive blinded OFC to walnut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg (ie cumulative dose of ≤444 mg) of walnut protein. * With body weight (as measured at screening) and total serum IgE level (as measured within 3 months of screening) suitable for RPT904 dosing (per RPT904 dosing table). * Female Participants: * 1\. Must not be pregnant or breastfeeding. * 2\. Women of non-childbearing potential (e.g., surgically sterile or postmenopausal) are eligible. * 3\. Women of childbearing potential must have a negative pregnancy test before starting study treatment, agree to use a protocol-defined method of contraception during the study and for at least 16 months after the last dose, and must not donate eggs or undergo egg retrieval during this period. * Male Participants: * 1\. Must agree to either remain abstinent from heterosexual intercourse (if that is their usual lifestyle) or use protocol-defined contraception during the study and for 16 months after the last dose. * 2\. Must not donate semen or participate in sperm banking during this time, and if they have a female partner of childbearing potential, she should also use effective contraception. Exclusion Criteria: * Clinically significant lab abnormalities at screening. * Sensitivity or suspected/known allergy to any component of the active or placebo OFC material (excluding the test allergens peanut, milk, egg, walnut, and cashew being tested), or drugs related to RPT904 (eg, monoclonal antibodies, polyclonal gamma globulin). * Uncontrolled or severe asthma/wheezing at screening. * Current use of oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers (oral or topical). * Past or current immunotherapy to any study foods within 6 months of screening. * Treatment with immunomodulatory therapy within 6 months of screening. * Currently in the "build-up phase" of inhalant allergen immunotherapy (i.e., not yet on maintenance). Note: individuals on stable maintenance dosing may be eligible. * Past or current medical problems (eg, severe latex allergy), chronic diseases (other than asthma/wheezing, atopic dermatitis, or rhinitis) requiring therapy (eg, heart disease, diabetes), abnormal physical findings or lab results not listed above that, in the Principal Investigator's opinion, may increase study related risks, hinder protocol compliance, or impact data quality or interpretation .

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Conditions

The condition(s) this trial relates to.

Egg Hypersensitivity food allergy Milk Hypersensitivity Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ig-E mediated food allergy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    37 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Children's

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Asthma & Allergy Associates, P.C.

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • BC Children's Hospital

    RECRUITING

    Vancouver, British Columbia, V6H3V4, Canada

  • Boston's Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T1C5, Canada

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital at Westmead

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Clinical Research Institute, Inc

    RECRUITING

    Minneapolis, Minnesota, 55402, United States

  • Dell Children's Medical Group

    RECRUITING

    Austin, Texas, 78723, United States

  • Fiona Stanely Hospital

    RECRUITING

    Perth, Western Australia, 6150, Australia

  • Halton Pediatric Allergy

    RECRUITING

    Burlington, Ontario, L7L6W6, Canada

    Contact Email: •••••@•••••

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • McGill Unviversity

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

  • Northwell Health

    RECRUITING

    Great Neck, New York, 11021, United States

  • Ottawa Allergy Research Corporation

    RECRUITING

    Ottawa, Ontario, K1H1E4, Canada

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Phoenix Childrens

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

    Contact Email: •••••@•••••

  • Sean N. Parker Center for Allergy and Asthma Research

    RECRUITING

    Palo Alto, California, 94304, United States

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G2G3, Canada

  • The Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC)

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Women's & Children's Hospital

    RECRUITING

    North Adelaide, South Australia, 5006, Australia