UKK-0018 immunotherapy for peanut allergy

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

This trial will test whether injections of UKK-0018 can retrain the immune system to reduce allergic reactions in adults with peanut allergy.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Ukko Inc (industry)
• Locations: 5 sites (Camperdown, New South Wales and 4 other locations)
• Trial ID: NCT07349212 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label multicenter trial will give escalating doses of UKK-0018 injections to adults with documented peanut allergy to study safety, tolerability, and immune responses. Participants will be screened with skin prick testing and a double-blind placebo-controlled food challenge (DBPCFC) before enrollment, then receive planned dosing with follow-up visits to monitor reactions and immune markers. The investigational protein has been modified to reduce IgE binding with the aim of lowering the risk of severe allergic reactions compared with unmodified allergens. An optional dose-expansion cohort may be opened if emerging data support additional evaluation of a selected dose/regimen.

Who should consider this trial

Good fit: Adults aged 18–55 with physician-diagnosed peanut allergy, a positive skin prick test, and a confirmed reaction on screening peanut challenge who can provide informed consent and comply with study visits.

Not a fit: People with prior life-threatening anaphylaxis, uncontrolled asthma, significant chronic or active medical conditions, immunodeficiency, pregnancy or breastfeeding, or those outside the 18–55 age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, UKK-0018 could reduce the severity or frequency of allergic reactions after accidental peanut exposure and make immunotherapy safer.

How similar studies have performed: Other allergen immunotherapies, including approved oral peanut immunotherapy, have increased tolerance in some patients, but injectable, IgE-reduced first-in-human approaches like UKK-0018 are novel and less tested.

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

Where this trial is running

Camperdown, New South Wales and 4 other locations

• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (NOT_YET_RECRUITING)
• Flinders Medical Center — Bedford Park, South Australia, Australia (NOT_YET_RECRUITING)
• The Royal Melbourne Hospital — Fitzroy, Victoria, Australia (NOT_YET_RECRUITING)
• Fiona Stanley Hospital — Perth, Western Australia, Australia (NOT_YET_RECRUITING)
• Pacific Clinical Research Network - Auckland — Takapuna, Auckland, New Zealand (RECRUITING)

Study contacts

• Study coordinator: Clinical Development Officer

Conditions: Peanut-Induced Anaphylaxis, Peanut Allergy, peanut, peanut allergy