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NCT Number: NCT07349212

UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies

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.

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Key information

Conditions

Peanut-Induced Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Allergy Peanut Hypersensitivity

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UKK-0018

Biological

UKK0018 is an immunotherapeutic treatment of peanut allergies

Primary outcomes

  1. To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of solicited local and systemic adverse reactions

    Time frame: 7 days after each injection

    Numbers and percentages of participants with solicited local and systemic adverse reactions

  2. To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of unsolicited adverse events

    Time frame: 28 days after each injection

    Numbers and percentages of participants with unsolicited adverse events (AEs)

  3. To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of medically-attended adverse events (MAAEs

    Time frame: 30 weeks after first injection

    Numbers and percentages of participants with medically-attended adverse events (MAAEs)

  4. To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of adverse events of special interest (AESI)

    Time frame: 30 weeks after first injection

    Numbers and percentages of participants with adverse events of special interest (AESI)

  5. To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of serious adverse events (SAE)

    Time frame: 30 weeks after first injection

    Numbers and percentages of participants with serious adverse events (SAE)

Secondary outcomes

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

    Time frame: at 28 days post last treatment

    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.

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

    Time frame: at 28 days post treatment

    The number of participants able to ingest ≥ 600 mg of peanut protein in a DBPCFC

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

    Time frame: up to 30 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Development Officer

CONTACT

[email protected]

+1 503 915 1400

Sponsors and collaborators

Lead sponsor

Ukko Inc

Industry

Registry information

Official study title

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

Acronym: UKK-0018

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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