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RECRUITING Phase 2

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

NCT07220811 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • OTHER Placebo
  • DRUG RPT904

Study Locations (15)

New South Wales

  • St Vincent's Hospital Sydney — Darlinghurst
  • Children's Hospital at Westmead — Westmead

Ontario

  • Halton Pediatric Allergy — Burlington
  • Ottawa Allergy Research Corporation — Ottawa

Arkansas

  • Arkansas Children's — Little Rock

California

  • Sean N. Parker Center for Allergy and Asthma Research — Palo Alto

Colorado

  • Asthma & Allergy Associates, P.C. — Colorado Springs

District of Columbia

  • Children's National Hospital — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Center for Advanced Pediatrics — Atlanta

Massachusetts

  • Boston's Children's Hospital — Boston

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2025-10-22
Est. Completion 2028-01
Phase Phase 2

Sponsor

RAPT Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07220811

The ClinicalTrials.gov registry entry for NCT07220811 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RAPT Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ig-E Mediated Food Allergy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07220811 reports 15 study locations spanning 13 distinct geographic areas — top geographies include New South Wales, Ontario, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07220811 about?

NCT07220811 is a clinical study titled "Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy". 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...

What is the current status of trial NCT07220811?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-10-22. Estimated completion is 2028-01.

What conditions does trial NCT07220811 study?

This clinical trial studies the following conditions: Ig-E Mediated Food Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07220811?

The interventions under investigation include: Placebo (OTHER), RPT904 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07220811?

This trial is sponsored by RAPT Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07220811 being conducted?

This trial has 15 study locations across Arkansas, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial