RecruitingPhase 1Phase 2NCT07349212

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


Sponsor

Ukko Inc

Enrollment

40 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human Phase 1/2 study tests UKK-0018, a new investigational injectable immunotherapy designed to gradually retrain the immune system to tolerate peanut proteins, reducing the risk of allergic reactions in people with peanut allergy. Unlike standard oral immunotherapy, UKK-0018 has been modified to reduce binding to IgE antibodies — the molecules responsible for triggering allergic reactions — which may make the treatment safer. Adults aged 18–55 with a physician-confirmed peanut allergy, a positive skin prick test, and a confirmed reaction to peanut protein during a supervised challenge test are eligible; those with uncontrolled asthma, cardiovascular disease, active infections, a history of life-threatening anaphylaxis, or who are pregnant are excluded. The study has a screening period, an injection period with escalating dose levels, and a follow-up period to assess immune changes and safety. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALUKK-0018

UKK0018 is an immunotherapeutic treatment of peanut allergies


Locations(5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Flinders Medical Center

Bedford Park, South Australia, Australia

The Royal Melbourne Hospital

Fitzroy, Victoria, Australia

Fiona Stanley Hospital

Perth, Western Australia, Australia

Pacific Clinical Research Network - Auckland

Takapuna, Auckland, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07349212