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RECRUITING
NCT07220811
PHASE2

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

Sponsor: RAPT Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

RPT904

Subcutaneous injection once every 8 weeks

DRUG

RPT904

Subcutaneous injection once every 12 weeks

OTHER

Placebo

Subcutaneous injection at the intervening dosing visits

DRUG

RPT904

Subcutaneous injection once every 8 weeks (Part 2)

DRUG

RPT904

Subcutaneous injection once every 12 weeks (Part 2)

OTHER

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