RPT904

A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy

RPT904-01

About the Study

A) We are conducting a phase 2b, randomised double-blind, placebo-controlled clinical trial to evaluate PRT904, a next generation long-acting, anti-IgE monoclonal antibody for the treatment of the anti-IgE mediated food allergies. This study includes adolescents and adults ages 12-55 years with documented allergies to food such as peanut, milk, egg, cashew, or walnut.

In the part 1 of the study, approximately 100 participants will be randomized to 24 weeks of treatment with RPT904 or placebo. In the next part, placebo group will receive the two different doses of the RPT904 and the participants receiving RPT904 will continue receiving their original assigned treatments for 24 weeks.

This study designed to assess the safety, tolerability and effectiveness of PRT904 in helping the patients tolerated higher amounts of food allergens and reducing allergic reaction. PRT904 has been engineered to have extended half-life and allowing for less frequent dosing (every 8-12 weeks) which may reduce treatment burden compared to current therapies.

B) This is a phase 2b, multi-center randomised, double-blind, placebo controlled clinical trial evaluating RAPT904, a next generation long-acting, anti-IgE monoclonal antibody for the treatment of IgE-mediated food allergies. the study will enroll approximately 100 participants age 12-55 years with confirmed allergies to peanut, milk, egg, cashew, or walnut.

This study consists of two 24 weeks treatment periods. in Part 1, Participants will be randomly assigned to receive RPT904 every 8 or 12 weeks or placebo. In part2, participants will be randomly assigned to receive placebo will switch to RAPT904 while those already received RAPT904 will continue their assigned dosing schedule. Participants will attend reqular study visits and compelet supervised food allergy challanges due to evaluated their response.

The primary objective is to assess whether RPT904 can increase tolerance to food allergens and reduce allergic reactions, while also evaluating its safety and tolerability. RPT904 is designed with an extended half-life, allowing for less frequent dosing and the potential to improve convenience, treatment adherence and clinical outcomes for patients with food allergies.

Who Can Join?

You may qualify if you:

• Are 12 to <56 years of age at screening
• Have allergic to at least 1 of the following: peanut, milk, egg, cashew, or walnut
• Are able to understand the study and provide informed consent (parent, guardian consent required for minors)
• Agree to follow study requirement including study visits, procedures and safety monitoring.

Exclusions:

• Have uncontrolled or severe asthma/wheezing at screening
• Are pregnant or breastfeeding
• Have a known allergy or sensitivity to similar antibody treatments or study materials.
• Are currently using certain medication that may interfere with the study (such as systemic, steroids, immunotherapy, or immunomodulatory drugs)
• Have other medication or health condition that, in the investigator's opinion, may affect safety or study participants.

Study Details

Duration approximately 68 weeks:

• • • Screening: 4 weeks
    • Treatment: 24 weeks for Part 1, 24 weeks part 2
    • Follow up: 16 weeks

What’s Involved?

• Standard Physical Examination, Questionnaire
• Spirometry, Skin Prick Test, blood test, Pregnancy test (if needed)
• Oral Food Challenges (Allergen and placebo)

Clinical Trial link

https://clinicaltrials.gov/study/NCT07220811