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.
Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Subcutaneous injection once every 8 weeks
Subcutaneous injection once every 12 weeks
Subcutaneous injection at the intervening dosing visits
Subcutaneous injection once every 8 weeks (Part 2)
Subcutaneous injection once every 12 weeks (Part 2)
Subcutaneous injection on schedules matching both the Q8W and Q12W arms (Part 1). Subcutaneous injection at the intervening dosing visits (Part 2)
Arkansas Children's
Little Rock, Arkansas, United States
RECRUITINGAsthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
RECRUITINGChildren's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States
RECRUITINGClinical Research Institute, Inc
Minneapolis, Minnesota, United States
RECRUITINGNorthwell Health
Great Neck, New York, United States
RECRUITINGChildren's Hospital at Westmead
Westmead, New South Wales, Australia
RECRUITINGHalton Pediatric Allergy
Burlington, Ontario, Canada
RECRUITINGOttawa Allergy Research Corporation
Ottawa, Ontario, Canada
RECRUITINGTo compare the ability to consume a food without dose-limiting symptoms during a DBPCFC at the end of Part 1 after treatment with either RPT904 or placebo
Proportion of participants who consumed a single dose of ≥600 mg (ie, a cumulative dose of ≥1044 mg) of peanut or cashew protein, or a single dose of ≥1000 mg (ie, a cumulative dose of ≥2044 mg) of milk, egg, or walnut protein without dose-limiting symptoms at Part 1 DBPCFC
Time frame: Approximately 24 weeks
To evaluate safety during treatment with either RPT904 or placebo
Frequency of treatment-emergent adverse events (TEAEs) related to study therapy regimen
Time frame: Approximately 48 weeks
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