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Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Sponsor: RAPT Therapeutics, Inc.
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.
Official title: Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Key Details
Gender
All
Age Range
12 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-10-22
Completion Date
2028-01
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
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)
Locations (21)
Arkansas Children's
Little Rock, Arkansas, United States
Sean N. Parker Center for Allergy and Asthma Research
Palo Alto, California, United States
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
Boston's Children's Hospital
Boston, Massachusetts, United States
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States
Northwell Health
Great Neck, New York, United States
University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC)
Chapel Hill, North Carolina, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Women's & Children's Hospital
North Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
Fiona Stanely Hospital
Perth, Western Australia, Australia
Halton Pediatric Allergy
Burlington, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada