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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UKK-0018 | Experimental | UKK0018 is an immunotherapeutic for the treatment of peanut allergies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UKK-0018 | Biological | UKK0018 is an immunotherapeutic treatment of peanut allergies |
|
| Measure | Description | Time Frame |
|---|---|---|
| To 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 | 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) | 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) | 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) | 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) | 30 weeks after first injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 28 days post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Officer | Contact | +1 503 915 1400 | sharron@ukko.us |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Not yet recruiting | Camperdown | New South Wales | 2050 | Australia |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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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.
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| 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 | at 28 days 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 | up to 30 weeks |
| Flinders Medical Center | Not yet recruiting | Bedford Park | South Australia | 5042 | Australia |
|
| The Royal Melbourne Hospital | Recruiting | Fitzroy | Victoria | 3065 | Australia |
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| Fiona Stanley Hospital | Not yet recruiting | Perth | Western Australia | 6150 | Australia |
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| Pacific Clinical Research Network - Auckland | Recruiting | Takapuna | Auckland | 0622 | New Zealand |
|
| D007154 | Immune System Diseases |