UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies (UKK-0018)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peanut Allergy; Peanut-Induced Anaphylaxis
• Intervention / Treatment: Biological: UKK-0018

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Development Officer; Phone Number: +1 503 915 1400; Email: sharron@ukko.us

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Not yet recruiting
      • Royal Prince Alfred Hospital
      • Contact: Alex Stoyanov, MD; Phone Number: (02) 9515 7585; Email: Alex.Stoyanov@health.nsw.gov.au
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Not yet recruiting
      • Flinders Medical Center
      • Contact: Syed Ali, MD; Email: Health.ResearchHubCT@sa.gov.au
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Not yet recruiting
      • The Royal Melbourne Hospital
      • Contact: Kymble Spriggs; Phone Number: 03 9342 7000; Email: AllergyResearch@mh.org.au
  • Western Australia
    • Perth, Western Australia, Australia, 6150
      • Not yet recruiting
      • Fiona Stanley Hospital
      • Contact: Michael O Sullivan, MD; Phone Number: 08 6456 2222; Email: fshimmunology.research@health.wa.gov.au
• New Zealand
  • Auckland
    • Takapuna, Auckland, New Zealand, 0622
      • Recruiting
      • Pacific Clinical Research Network - Auckland
      • Contact: Enrollment Coordinator; Phone Number: +64 9 242 3321; Email: Auckland@pcrn.co.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UKK-0018; UKK0018 is an immunotherapeutic for the treatment of peanut allergies	Biological: UKK-0018; UKK0018 is an immunotherapeutic treatment of peanut allergies

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy	The number of participants able to increase their tolerated dose (eg, no more than mild dose-limiting symptoms) of peanut protein at least 10-fold in the exit double-blind placebo-controlled food challenge (DBPCFC) compared to the screening DBPCFC.	at 24 weeks post last treatment
To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy	The number of participants able to ingest ≥ 600 mg of peanut protein in a DBPCFC	at 24 weeks post treatment
To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018	Change from baseline in immunogenicity markers measured by geometric mean ratios (GMRs) and 95% confidence intervals (CIs) at prespecified time points up to study completion	up to 30 weeks

Collaborators and Investigators

• Sponsor: Ukko Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: peanut; peanut allergy
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: UKKO-18-101-ANZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No