Peanut Allergy, Peanut-Induced Anaphylaxis
Conditions
Keywords
peanut, peanut allergy
Brief summary
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
BIOLOGICALUKK-0018
UKK0018 is an immunotherapeutic treatment of peanut allergies
Sponsors
Ukko Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of solicited local and systemic adverse reactions | 7 days after each injection | Numbers and percentages of participants with solicited local and systemic adverse reactions |
| To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of unsolicited adverse events | 28 days after each injection | Numbers and percentages of participants with unsolicited adverse events (AEs) |
| To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of medically-attended adverse events (MAAEs | 30 weeks after first injection | Numbers and percentages of participants with medically-attended adverse events (MAAEs) |
| To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of adverse events of special interest (AESI) | 30 weeks after first injection | Numbers and percentages of participants with adverse events of special interest (AESI) |
| To assess the safety and tolerability of repeated dosing of UKK-0018 administered IM of serious adverse events (SAE) | 30 weeks after first injection | Numbers and percentages of participants with serious adverse events (SAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the preliminary efficacy of repeated dosing of UKK-0018 administered IM in participants with peanut allergy | 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. |
| To assess the preliminary efficacy of repeated IM dosing of UKK-0018 in participants with peanut allergy | at 28 days post treatment | The number of participants able to ingest ≥ 600 mg of peanut protein in a DBPCFC |
| To assess the effect of dose regimen on immunogenicity and biomarkers following repeated IM dosing of UKK-0018 | 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 |
Countries
Australia, New Zealand
Contacts
CONTACTClinical Development Officer
Outcome results
None listed