UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies

NCT07349212 · tracked via the Priya Life Science Australia tracker

Sponsor

Ukko Inc

Phase

Phase 1/2

Started

2026-02-18

Last updated

2026-06-25

Condition(s) studied

Peanut-Induced AnaphylaxisPeanut Allergy

Investigational drug(s) / intervention(s)

UKK-0018

UKK-0018: UKK0018 is an immunotherapeutic treatment of peanut allergies

Study 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

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Inclusion Criteria: * Adults 18-55 years old * documented history of physician-diagnosed peanut allergy * positive skin prick test (SPT) * screening DBPCFC peanut protein * contraception use should be consistent with local regulations * capable of providing signed written informed consent Exclusion Criteria: * asthma based on NHLBI * uncontrolled cardiovascular disease * chronic disease history * exacerbation of dermatological conditions * life threatening episodes of anaphylaxis * active infections * poor physical or blood chemistry * immunodeficiency, bleeding disorders, malignancies * hypersensitivities to epinephrine, inactive ingredients in therapy * pregnant or breast feeding

Primary outcome measure(s)

To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of solicited local and systemic adverse reactions — 7 days after each injection
Numbers and percentages of participants with solicited local and systemic adverse reactions
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of unsolicited adverse events — 28 days after each injection
Numbers and percentages of participants with unsolicited adverse events (AEs)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of medically-attended adverse events (MAAEs — 30 weeks after first injection
Numbers and percentages of participants with medically-attended adverse events (MAAEs)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of adverse events of special interest (AESI) — 30 weeks after first injection
Numbers and percentages of participants with adverse events of special interest (AESI)
To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of serious adverse events (SAE) — 30 weeks after first injection
Numbers and percentages of participants with serious adverse events (SAE)

Trial sites (5)

Facility	City	Region	Status
Royal Prince Alfred Hospital	Camperdown	New South Wales	Not Yet Recruiting
Flinders Medical Center	Bedford Park	South Australia	Not Yet Recruiting
The Royal Melbourne Hospital	Fitzroy	Victoria	Recruiting
Fiona Stanley Hospital	Perth	Western Australia	Not Yet Recruiting
Pacific Clinical Research Network - Auckland	Takapuna	Auckland	Recruiting

Other trials for the same condition

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) Active, not recruiting

Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children Active, not recruiting

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07349212 on ClinicalTrials.gov ↗ ← All trials in Australia