Phase 2b Study of RPT904 for IgE-Mediated Food Allergy
This study is testing a new medication called RPT904 for people with IgE-mediated food allergy. RPT904 is a monoclonal antibody, a type of protein that can block allergic reactions. The study aims to see if RPT904, given as a shot under the skin every 8 or 12 weeks, can help you eat certain foods without severe allergic symptoms. About 100 participants aged 12 to 55 who are allergic to peanut, milk, egg, cashew, or walnut will join. Some will receive RPT904, and others will receive a placebo (an inactive substance) to compare the effects. The main goal is to see if participants can eat a food without dose-limiting symptoms after about 24 weeks of treatment.
- Study design
- This is a Phase 2b randomized, double-blind, placebo-controlled study. Approximately 100 participants will be enrolled.
- What's involved
- Participants will receive RPT904 or placebo as a subcutaneous injection (a shot under the skin) every 8 or 12 weeks, plus a loading dose at Week 2. The first part of the study lasts about 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at approximately 24 weeks.
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NCT07220811
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Recruiting
PHASE2Ages 12–55InterventionalTreatmentRAPT Therapeutics, Inc.
~100 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:RPT904Placebo
At a glance
Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placebo
Measured over Approximately 24 weeks
Conditions
Where it's being run
37 sites across 24 statesColorado3
Victoria3
Ontario3
Massachusetts2
New York2
Pennsylvania2
Texas2
New South Wales2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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 .
What this trial measures
- To compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placeboApproximately 24 weeks
Proportion of participants who consumed a single dose of ≥600 mg (ie, a cumulative dose of ≥1044 mg) of peanut or cashew protein, or a single dose of ≥1000 mg (ie, a cumulative dose of ≥2044 mg) of milk, egg, or walnut protein without dose-limiting symptoms at Part 1 DBPCFC