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RPT904

Phase 2

Ig-E Mediated Food Allergy | Small molecule | Other |RAPT Therapeutics, Inc.|Last Updated: Jul 28, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

RPT904 · 1 trial · 1 indication

Phase 2 1
NCT07220811Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food AllergyIg-E Mediated Food Allergy
RECRUITING100 Analytics
PHASE2RECRUITING
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Ig-E Mediated Food AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Approximately 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

Secondary Endpoints

To evaluate safety during treatment with either RPT904 or placebo
Approximately 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RPT904 (Q8W)EXPERIMENTALRPT904 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 (Q12W)EXPERIMENTALRPT904 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.
PlaceboPLACEBO_COMPARATORPlacebo 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.

Interventions

NameTypeDescription
RPT904DRUGSubcutaneous injection once every 8 weeks
PlaceboOTHERSubcutaneous injection at the intervening dosing visits
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Eligibility Criteria

Age Range12 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites37

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 wal...

Countries:United StatesAustraliaCanada
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Recent Changes (Last 90 Days)

LOWJul 28, 2026NCT07220811lastUpdatePostDate: changed
LOWJul 28, 2026NCT07220811lastUpdatePostDate: changed
LOWJul 9, 2026NCT07220811lastUpdatePostDate: changed
LOWJul 9, 2026NCT07220811lastUpdatePostDate: changed

Frequently asked questions about RPT904

What is RPT904 used for?

RPT904 is an investigational small molecule being developed for the treatment of IgE-mediated food allergy. It is currently in Phase 2 clinical development and is being studied as a monotherapy in participants with this condition.

What does RPT904 target?

RPT904 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its potential to treat IgE-mediated food allergy, a condition where the immune system overreacts to certain foods.

Who makes RPT904?

RPT904 is being developed by RAPT Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RAPT.

What phase is RPT904 in?

RPT904 is currently in Phase 2 clinical development. It is being evaluated in a Phase 2b study as a monotherapy for IgE-mediated food allergy, and the trial is actively recruiting participants.

What clinical trials is RPT904 in?

RPT904 is being studied in a Phase 2b clinical trial with the identifier NCT07220811. This randomized, double-blind, placebo-controlled trial is recruiting 100 participants aged 12 years and older with IgE-mediated food allergy across the United States, Australia, and Canada.