Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ig-E Mediated Food Allergy

In brief

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.

Key facts

Study ID

NCT07220811

Run by

RAPT Therapeutics, Inc.

People needed

100

Starts

2025-10-22

Expected to finish

2028-01-01

Last updated by the study team

2026-07-28

Who can join

Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 it is running

• Phoenix Childrens — Phoenix, Arizona, United States (enrolling)
• Arkansas Children's — Little Rock, Arkansas, United States (enrolling)
• Sean N. Parker Center for Allergy and Asthma Research — Palo Alto, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Asthma & Allergy Associates, P.C. — Colorado Springs, Colorado, United States (enrolling)
• National Jewish Health — Denver, Colorado, United States (enrolling)
• Children's National Hospital — Washington D.C., District of Columbia, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta, Georgia, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Boston's Children's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Clinical Research Institute, Inc — Minneapolis, Minnesota, United States (enrolling)
• Northwell Health — Great Neck, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC) — Chapel Hill, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• Dell Children's Medical Group — Austin, Texas, United States (enrolling)
• Texas Children's Hospital — Houston, Texas, United States (enrolling)
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (enrolling)
• Children's Hospital at Westmead — Westmead, New South Wales, Australia (enrolling)
• Queensland Children's Hospital — South Brisbane, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

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