UKK-0018 is an Immunotherapeutic for Treatment of Peanut Allergies

Phase 2Not Yet RecruitingNCT07349212

Ukko Inc40 enrolled

Overview

This study will test a new investigational treatment called UKK-0018. UKK-0018 is 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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peanut-Induced Anaphylaxis Peanut Allergy

Interventions

UKK-0018BIOLOGICAL

UKK0018 is an immunotherapeutic treatment of peanut allergies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

The Royal Melbourne Hospital

Fitzroy, Victoria, Australia

Pacific Clinical Research Network

Auckland, New Zealand

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

Central Contacts

Clinical Development Officer

CONTACT

+1 503 915 1400 sharron@ukko.us

Data from ClinicalTrials.gov

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