UKK-0018 is an Immunotherapeutic for Treatment of Peanut Allergies

NCT ID: NCT07349212

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-11-01

Brief Summary

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This study will test a new investigational treatment called UKK-0018. UKK-0018 is 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

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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

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Peanut-Induced Anaphylaxis Peanut Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UKK-0018

UKK0018 is an immunotherapeutic for the treatment of peanut allergies

Group Type EXPERIMENTAL

UKK-0018

Intervention Type BIOLOGICAL

UKK0018 is an immunotherapeutic treatment of peanut allergies

Interventions

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UKK-0018

UKK0018 is an immunotherapeutic treatment of peanut allergies

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ukko Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Royal Melbourne Hospital

Fitzroy, Victoria, Australia

Site Status

Pacific Clinical Research Network

Auckland, , New Zealand

Site Status

Countries

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Australia New Zealand

Central Contacts

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Clinical Development Officer

Role: CONTACT

+1 503 915 1400

Facility Contacts

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Kymble Spriggs

Role: primary

0412356560

Role: primary

0399704240

Other Identifiers

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UKKO-18-101-ANZ

Identifier Type: -

Identifier Source: org_study_id

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