Peanut-Induced AnaphylaxisPhase 1/2UKK-0018NCT07349212
UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies
A Phase 1/2 study testing UKK-0018 in people with Peanut-Induced Anaphylaxis and Peanut Allergy, run by Ukko Inc at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Peanut-Induced Anaphylaxis, Peanut Allergy
- What is being tested?
- UKK-0018
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Feb 2026to 1 Nov 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- asthma based on NHLBI
- uncontrolled cardiovascular disease
- chronic disease history
- exacerbation of dermatological conditions
- life threatening episodes of anaphylaxis
- active infections
Show all 10Show fewer
- poor physical or blood chemistry
- immunodeficiency, bleeding disorders, malignancies
- hypersensitivities to epinephrine, inactive ingredients in therapy
- pregnant or breast feeding
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia5 sites, 5 recruiting
- Not yet recruiting
Flinders Medical Center
Bedford Park, South Australia, 5042
Syed Ali, MD, Health.ResearchHubCT@sa.gov.au
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Alex Stoyanov, MD, (02) 9515 7585, Alex.Stoyanov@health.nsw.gov.au
- Recruiting
St Vincents Hospital
Darlinghurst, New South Wales, 2010
Contact SVHS, PeanutAllergy@svha.org.au
Winnie Tong, MD
- Recruiting
The Royal Melbourne Hospital
Fitzroy, Victoria, 3065
Kymble Spriggs, 03 9342 7000, AllergyResearch@mh.org.au
- Recruiting
Fiona Stanley Hospital
Perth, Western Australia, 6150
Contact, 08 6456 2222, fshimmunology.research@health.wa.gov.au
Michael O Sullivan, MD
New Zealand1 site, 1 recruiting
- Recruiting
Pacific Clinical Research Network - Auckland
Takapuna, Auckland, 0622
Enrollment Coordinator, +64 9 242 3321, Auckland@pcrn.co.nz
About this study
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
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.
Read the 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.
- Conditions
- Peanut-Induced Anaphylaxis, Peanut Allergy
- Being tested
- UKK-0018
- Keywords
- peanut, peanut allergy
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UKK-0018Biological
UKK0018 is an immunotherapeutic treatment of peanut allergies
| Study group | Role | What they receive |
|---|---|---|
| UKK-0018 | Experimental | UKK0018 is an immunotherapeutic for the treatment of peanut allergies Receives: Biological: UKK-0018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 30 weeks after first injection
Secondary outcomes (3)
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.
Measured: at 28 days post last treatment
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
Measured: 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
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Feb 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut-Induced AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ukko Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349212
- Sponsor's protocol ID
- UKKO-18-101-ANZ
- Acronym
- UKK-0018
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No