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Recruiting NCT07349212

UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies

Phase I / Phase II Interventional Peanut-Induced Anaphylaxis Peanut Allergy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UKK-0018.
Who it may be relevant to
Registry conditions: Peanut-Induced Anaphylaxis, Peanut Allergy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Interventions

  • Biological UKK-0018
    UKK0018 is an immunotherapeutic treatment of peanut allergies

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (3)
  • 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]
  • To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy [Time frame: at 28 days post treatment]
  • To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018 [Time frame: up to 30 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 4 centers
  • Royal Prince Alfred Hospital — Camperdown
  • Flinders Medical Center — Bedford Park
  • The Royal Melbourne Hospital — Fitzroy
  • Fiona Stanley Hospital — Perth
New Zealand · 1 center
  • Pacific Clinical Research Network - Auckland — Takapuna

Identifiers

NCT: NCT07349212 · UKKO-18-101-ANZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗