Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Public ClinicalTrials.gov record NCT07220811. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07220811
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2025
- Primary completion
- Mar 31, 2027
- Completion
- Dec 31, 2027
- Last update posted
- Jul 27, 2026
2025 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens | Phoenix | Arizona | 85016 | Recruiting |
| Arkansas Children's | Little Rock | Arkansas | 72202 | Recruiting |
| Sean N. Parker Center for Allergy and Asthma Research | Palo Alto | California | 94304 | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Recruiting |
| Asthma & Allergy Associates, P.C. | Colorado Springs | Colorado | 80907 | Recruiting |
| National Jewish Health | Denver | Colorado | 80206 | Recruiting |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Recruiting |
| University of South Florida | Tampa | Florida | 33613 | Recruiting |
| Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Atlanta | Georgia | 30329 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Boston's Children's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Recruiting |
| Clinical Research Institute, Inc | Minneapolis | Minnesota | 55402 | Recruiting |
| Northwell Health | Great Neck | New York | 11021 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC) | Chapel Hill | North Carolina | 27599 | Recruiting |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | Recruiting |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Vanderbilt University | Nashville | Tennessee | 37232 | Recruiting |
| Dell Children's Medical Group | Austin | Texas | 78723 | Recruiting |
| Texas Children's Hospital | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07220811, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07220811 live on ClinicalTrials.gov.