UKK-0018 immunotherapy for peanut allergy
Official title: 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
Run by Ukko Inc · NCT07349212 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Ukko Inc Industry-sponsored |
| Locations | 6 sites (Camperdown, New South Wales and 5 other locations) |
| Status | Recruiting |
| Started | February 18, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | November 1, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07349212 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia Recruiting -
St Vincents Hospital
Darlinghurst, New South Wales, Australia Recruiting -
The Royal Melbourne Hospital
Fitzroy, Victoria, Australia Recruiting -
Fiona Stanley Hospital
Perth, Western Australia, Australia Recruiting -
Pacific Clinical Research Network - Auckland
Takapuna, Auckland, New Zealand Recruiting -
Flinders Medical Center
Bedford Park, South Australia, Australia Not yet recruiting
Study contacts
- Study coordinator: Clinical Development Officer
- Email: sharron@ukko.us
- Phone: +1 503 915 1400
Similar studies
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This study tests whether adding tezepelumab to peanut oral immunotherapy can help people with peanut allergy build lasting tolerance.
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Investigating new methods for oral immunotherapy in food allergies
This study is testing new ways to use oral immunotherapy to help people with food allergies, like those to peanuts and milk, feel safer and have fewer allergic reactions during treatment.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.