Actively Recruiting
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Led by RAPT Therapeutics, Inc. · Updated on 2026-05-04
100
Participants Needed
26
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent.
- 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, confirmed by specific allergy tests and food challenges.
- Body weight and total serum IgE level suitable for RPT904 dosing.
- Female participants must not be pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use contraception during the study and for 16 months after the last dose.
- Male participants must agree to use contraception or remain abstinent during the study and for 16 months after the last dose.
You will not qualify if you...
- Clinically significant laboratory abnormalities at screening.
- Allergy or sensitivity to any component of the active or placebo food challenge materials or drugs related to RPT904.
- Uncontrolled or severe asthma or wheezing at screening.
- Current use of oral, injectable, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers.
- Immunotherapy to any study foods within 6 months prior to screening.
- Immunomodulatory therapy within 6 months prior to screening.
- Currently in the build-up phase of inhalant allergen immunotherapy.
- Past or current serious medical problems or chronic diseases requiring therapy that may increase study risks or affect compliance, as determined by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Arkansas Children's
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
Sean N. Parker Center for Allergy and Asthma Research
Palo Alto, California, United States, 94304
Actively Recruiting
3
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
4
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
5
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
University of South Florida
Tampa, Florida, United States, 33613
Actively Recruiting
7
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
Boston's Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States, 55402
Actively Recruiting
10
Northwell Health
Great Neck, New York, United States, 11021
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
12
University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
13
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
14
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
16
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Actively Recruiting
17
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
18
Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
19
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
20
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
21
The Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
22
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
23
Fiona Stanely Hospital
Perth, Western Australia, Australia, 6150
Actively Recruiting
24
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H3V4
Actively Recruiting
25
Halton Pediatric Allergy
Burlington, Ontario, Canada, L7L6W6
Actively Recruiting
26
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1H1E4
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here