UKK-0018 is an Immunotherapeutic for Treatment of Peanut Allergies
NCT ID: NCT07349212
Last Updated: 2026-01-16
Study Results
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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NOT_YET_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2026-02-01
2027-11-01
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
Based on emerging data an optional dose expansion cohort may be added, at a dose regimen to be determined.
TREATMENT
NONE
Study Groups
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UKK-0018
UKK0018 is an immunotherapeutic for the treatment of peanut allergies
UKK-0018
UKK0018 is an immunotherapeutic treatment of peanut allergies
Interventions
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UKK-0018
UKK0018 is an immunotherapeutic treatment of peanut allergies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Ukko Inc
INDUSTRY
Responsible Party
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Locations
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The Royal Melbourne Hospital
Fitzroy, Victoria, Australia
Pacific Clinical Research Network
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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UKKO-18-101-ANZ
Identifier Type: -
Identifier Source: org_study_id
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