Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Start Date
10/22/2025
Completion Date
1/1/2028
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.
Detailed Description
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Eligibility Criteria
Age Range: 12 years to 55 years
Interventions
RPT904
RPT904
Placebo
RPT904
RPT904
Placebo
Conditions
Locations
Phoenix Childrens
Phoenix, Arizona 85016
United States
Arkansas Children's
Little Rock, Arkansas 72202
United States
Sean N. Parker Center for Allergy and Asthma Research
Palo Alto, California 94304
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado 80907
United States
National Jewish Health
Denver, Colorado 80206
United States
Children's National Hospital
Washington D.C., District of Columbia 20010
United States
University of South Florida
Tampa, Florida 33613
United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30329
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston's Children's Hospital
Boston, Massachusetts 02115
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Clinical Research Institute, Inc
Minneapolis, Minnesota 55402
United States
Northwell Health
Great Neck, New York 11021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University of North Carolina at Chapel Hill Clinical and Translational Research Center( CTRC)
Chapel Hill, North Carolina 27599
United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United States
Vanderbilt University
Nashville, Tennessee 37232
United States
Dell Children's Medical Group
Austin, Texas 78723
United States
Texas Children's Hospital
Houston, Texas 77030
United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Australia
Children's Hospital at Westmead
Westmead, New South Wales 2145
Australia
Queensland Children's Hospital
South Brisbane, Queensland 4101
Australia
Women's & Children's Hospital
North Adelaide, South Australia 5006
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
The Royal Children's Hospital
Parkville, Victoria 3052
Australia
Perth Children's Hospital
Nedlands, Western Australia 6009
Australia
Fiona Stanely Hospital
Perth, Western Australia 6150
Australia
BC Children's Hospital
Vancouver, British Columbia V6H3V4
Canada
Halton Pediatric Allergy
Burlington, Ontario L7L6W6
Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario K1H1E4
Canada
The Hospital for Sick Children
Toronto, Ontario M5G2G3
Canada
CHU Sainte-Justine
Montreal, Quebec H3T1C5
Canada
McGill Unviversity
Montreal, Quebec H4A 3J1
Canada