UKK-0018 as an Immunotherapeutic for Treatment of Peanut Allergies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUkko Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18-55 years old
documented history of physician-diagnosed peanut allergy
positive skin prick test (SPT)
screening DBPCFC peanut protein
Disqualifiers
asthma based on NHLBI
uncontrolled cardiovascular disease
chronic disease history
exacerbation of dermatological conditions
Trial design
Design model
Single group
Treatments tested in this trial
UKK-0018
Biological/VaccineUKK0018 is an immunotherapeutic treatment of peanut allergies
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: UKK-0018Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 injection2
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 injection3
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 injection4
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 injectionSecondary outcomes
1
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.
Time frame
at 28 days post last treatment2
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
Time frame
at 28 days post treatment3
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
Time frame
up to 30 weeks Source ClinicalTrials.gov