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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
UKK0018 is an immunotherapeutic treatment of peanut allergies
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
NOT_YET_RECRUITINGFlinders Medical Center
Bedford Park, South Australia, Australia
NOT_YET_RECRUITINGThe Royal Melbourne Hospital
Fitzroy, Victoria, Australia
NOT_YET_RECRUITINGTo 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
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
Numbers and percentages of participants with unsolicited adverse events (AEs)
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
Numbers and percentages of participants with 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)
Numbers and percentages of participants with 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)
Numbers and percentages of participants with serious adverse events (SAE)
Time frame: 30 weeks after first injection
To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy
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.
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Fiona Stanley Hospital
Perth, Western Australia, Australia
NOT_YET_RECRUITINGPacific Clinical Research Network - Auckland
Takapuna, Auckland, New Zealand
RECRUITINGTime frame: at 24 weeks post last treatment
To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy
The number of participants able to ingest ≥ 600 mg of peanut protein in a DBPCFC
Time frame: at 24 weeks post treatment
To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018
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
Time frame: up to 30 weeks