Recruiting
Phase 2

RPT904

Sponsor:

RAPT Therapeutics, Inc.

Code:

NCT07220811

Conditions

Ig-E Mediated Food Allergy

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

Interventions

RPT904

RPT904

Placebo

RPT904

RPT904

Study Details

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.

Conditions

Ig-E Mediated Food Allergy

Study ID

NCT07220811

Start date

Oct 22, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 55

Healthy Volunteers: Not accepted

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 .

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RPT904 (Q8W)

RPT904 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.

experimental: RPT904 (Q12W)

RPT904 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.

placebo comparator: Placebo

Placebo 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

RPT904

Subcutaneous injection once every 8 weeks

RPT904

Subcutaneous injection once every 12 weeks

Placebo

Subcutaneous injection at the intervening dosing visits

RPT904

Subcutaneous injection once every 8 weeks (Part 2)

RPT904

Subcutaneous injection once every 12 weeks (Part 2)

Placebo

Subcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2)

Primary outcome measure

  • 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 [ Time Frame: Approximately 24 weeks ]

Central Contacts and Locations

Locations

Phoenix Childrens

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Danielle Humphrey

602-933-2104dhumphrey1@phoenixchildrens.com

Arkansas Children's

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Kim Norris

501-364-3726norriskd@archildrens.org

Sean N. Parker Center for Allergy and Asthma Research

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ji Hyun Choi

650-498-8383jihyunc@stanford.edu

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Courtney Evans

720-777-2624courtney.evans@childrenscolorado.org

Asthma & Allergy Associates, P.C.

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Sneha Tata

719-473-8330stata@aacos.com

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Alayna Penna

303-398-1379pennaa@njhealthj.org

Children's National Hospital

Recruiting

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

Contacts

Amanda Troger

202-476-4416atroger@childrensnational.org

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

Catherine Smith

813-631-4024catherinesmith@usf.edu

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Mary Vess

404-785-4476mary.vess@choa.org

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Brianna Fountain

617-643-6672blfountain@mgh.harvard.edu

Boston's Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Melanie Benitez

617-355-1734Melanie.Benitez@childrens.harvard.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Lea Franco

734-647-7999lmfranco@med.umich.edu

Clinical Research Institute, Inc

Recruiting

Minneapolis, Minnesota, United States, 55402

Contacts

Amy Roehl

612-333-2200amy.roehl@criminnesota.com

Northwell Health

Recruiting

Great Neck, New York, United States, 11021

Contacts

Aaqil Ali

516-622-5070aali27@northwell.edu

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jennifer Fishman

212-241-7566jennifer.fishman@mssm.edu

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Emily English

919-962-4961emilyp@email.unc.edu

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Glenda Knox

513-636-2733Glenda.Knox@cchmc.org

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Crissy Colodin

215-531-1436colodinc@chop.edu

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Craig Yarger

412-692-3905yargercw2@upmc.edu

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Alysee Sephel

615-875-2823alysse.sephel@vumc.org

Dell Children's Medical Group

Recruiting

Austin, Texas, United States, 78723

Contacts

Rachel Smith

512-256-4864rachel.smith@ascension-external.org

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Daisy Vita

832-824-3640dxtran1@texaschildrens.org

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H3V4

Contacts

Lianne Soller

+16048752345lsoller@bcchr.ca

Halton Pediatric Allergy

Recruiting

Burlington, Ontario, Canada, L7L6W6

Contacts

Roselle De Guzman

+19053159543studycoordinatoroparc@gmail.com

Ottawa Allergy Research Corporation

Recruiting

Ottawa, Ontario, Canada, K1H1E4

Contacts

Hazelyn Torres

+16137252102htorres@yangmedicine.com

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G2G3

Contacts

Alireza Berenjy

4168137654alireza.berenjy@sickkids.ca

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Nadine Mazari

5143454931nadine.mazari.hsj@ssss.gouv.qc.ca

McGill Unviversity

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Duncan Lejtenyi

+5149341934duncan.lejtenyi@muhc.mcgill.ca

More Information

Sponsor

RAPT Therapeutics, Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Ig-E Mediated food allergy
  • peanut allergy
  • milk allergy
  • egg allergy
  • cashew allergy
  • walnut allergy
  • RPT904
  • placebo
  • double-blind placebo-controlled food challenge (DBPCFC)
  • ozureprubart
  • JYB1904

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by RAPT Therapeutics, Inc. on 2026-07-28.