NCT07349212

UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies

A First-in-Human, Ascending Dose, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of UKK-0018 in Peanut Allergic Individuals

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ukko Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will test a new investigational treatment called UKK-0018. UKK-0018 as an immunotherapeutic for the treatment of peanut allergies. The treatment is given by injection and is designed to train the immune system to tolerate peanut exposure over time.

Detailed description

The study will assess how safe and well tolerated UKK-0018 is in people with known peanut allergy, and whether it can reduce the risk of allergic symptoms following exposure to peanut proteins. This is a first-in-human, open-label, multicenter study that will be conducted in adult participants with peanut allergy evaluating dose levels and regimens. It is anticipated that UKK-0018 can help retrain the immune system over time to respond safely to peanut proteins in case of accidental exposures. The modifications which reduce binding to IgE antibodies are anticipated to reduce risk of serious allergic reactions compared to standard of care. Based on emerging data an optional dose expansion cohort may be added. An optional dose expansion cohort may be added if supported by emerging data. The study is comprised of a screening period, intervention period, and follow-up period.

Conditions

• Peanut-Induced Anaphylaxis
• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	UKK-0018	UKK0018 is an immunotherapeutic treatment of peanut allergies

Timeline

• Start date: 2026-02-18
• Primary completion: 2027-03-01
• Completion: 2027-11-01
• First posted: 2026-01-16
• Last updated: 2026-04-09

Locations

5 sites across 2 countries: Australia, New Zealand