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RPT904 as a single treatment for IgE-mediated peanut, milk, egg, cashew, or walnut allergy

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

Phase 2 Interventional RAPT Therapeutics, Inc. · NCT07220811

This trial will test whether RPT904, a long-acting anti-IgE antibody given every 8 to 12 weeks, can reduce allergic reactions in people aged 12–55 with confirmed IgE-mediated food allergy to peanut, milk, egg, cashew, or walnut.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages12 Years to 55 Years
SexAll
SponsorRAPT Therapeutics, Inc. Industry-sponsored
Drugs / interventionsimmunotherapy
Locations26 sites (Little Rock, Arkansas and 25 other locations)
Trial IDNCT07220811 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2b trial enrolling about 100 participants aged 12 to less than 56 with confirmed IgE-mediated allergy to peanut, milk, egg, cashew, or walnut. In Part 1 (24 weeks) participants are randomized to RPT904 every 8 or 12 weeks (with a loading dose at Week 2) or placebo; in Part 2 (24 weeks) those on placebo are re-randomized to RPT904 and those on RPT904 continue their schedule. RPT904 is a next-generation, long-acting anti-IgE monoclonal antibody designed to be dosed every 8–12 weeks. Participants will attend clinic visits roughly every 2–6 weeks for dosing, monitoring, and safety assessments.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 to 55 with documented IgE-mediated allergy to peanut, milk, egg, cashew, or walnut confirmed by skin testing, specific IgE levels, and a positive oral food challenge per the protocol.

Not a fit: People with non–IgE-mediated food intolerances or allergies, those outside the 12–55 age range, individuals who do not meet the specific diagnostic criteria, or those unable to attend frequent in-person visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, RPT904 could raise the amount of allergen needed to cause a reaction and reduce how often patients need treatment by allowing dosing every 8–12 weeks.

How similar studies have performed: Previous studies of anti-IgE therapy such as omalizumab have shown the approach can raise reaction thresholds and aid desensitization, but long-acting anti-IgE monotherapy in this exact dosing schedule is relatively new.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 .

Where this trial is running

Little Rock, Arkansas and 25 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ig-E Mediated Food AllergyIg-E Mediated food allergypeanut allergymilk allergyegg allergycashew allergywalnut allergyRPT904
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.