NCT07349212

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
18mo left

Started Feb 2026

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 8, 2026

Last Update Submit

April 4, 2026

Conditions

Peanut-Induced AnaphylaxisPeanut Allergy

Keywords

peanutpeanut allergy

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy

    at 24 weeks post last treatment

  • To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy

    at 24 weeks post treatment

  • To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018

    up to 30 weeks

Study Arms (1)

UKK-0018

EXPERIMENTAL

UKK0018 is an immunotherapeutic for the treatment of peanut allergies

Biological: UKK-0018

Interventions

UKK-0018BIOLOGICAL

UKK0018 is an immunotherapeutic treatment of peanut allergies

UKK-0018

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

Flinders Medical Center

Bedford Park, South Australia, 5042, Australia

NOT YET RECRUITING

The Royal Melbourne Hospital

Fitzroy, Victoria, 3065, Australia

NOT YET RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

NOT YET RECRUITING

Pacific Clinical Research Network - Auckland

Takapuna, Auckland, 0622, New Zealand

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Clinical Development Officer

CONTACT

+1 503 915 1400sharron@ukko.us

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a first-in-human, open-label, multicenter study that will be conducted in adult participants (ages 18-55, inclusive) with peanut allergy in sequential cohorts evaluating dose levels and intervals (collectively called 'dose regimen'). Based on emerging data an optional dose expansion cohort may be added, at a dose regimen to be determined.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

AU(4)NZ(1)