A Phase 1/2 interventional study of Peanut SLIT-tablet and Placebo in Peanut Allergy, sponsored by ALK-Abelló A/S. Completed at 42 sites in 2 countries. Open to participants aged 4 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by ALK-Abelló A/S · Phase 1/2, Interventional, and Treatment
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
This is a phase I/II, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 3 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents; part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children; part 3 will evaluate the efficacy of 2 maintenance doses of the SLIT-tablet primarily in adolescents and children; a small number of adults may also be included.
Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study.
In part 1, subjects will receive a peanut SLIT-tablet with one of five doses once daily for 2 weeks.
In part 2, subjects will receive a series of increasing doses of the peanut SLIT-tablet, where each dose is taken once daily for 2 weeks. The entry dose for the up-dosing regimen will be determined from part 1.
In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo.
The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.
KEY INCLUSION CRITERIA:
Subjects are eligible to be included in the trial only if all the following criteria apply:
KEY EXCLUSION CRITERIA:
Subjects are excluded from the trial if any of the following criteria apply:
Part 1 and 2: Asthma according to below criteria:
Part 3: Asthma fulfilling the below criteria:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Biological: Peanut SLIT-tablet
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Biological: Peanut SLIT-tablet
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Biological: Peanut SLIT-tablet
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Biological: Peanut SLIT-tablet
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Biological: Peanut SLIT-tablet
Adults - UDR with once daily peanut SLIT-tablet
Biological: Peanut SLIT-tablet
Adolescents - UDR with once daily peanut SLIT-tablet
Biological: Peanut SLIT-tablet
Children - UDR with once daily peanut SLIT-tablet
Biological: Peanut SLIT-tablet
Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet
Biological: Peanut SLIT-tablet
Highly sensitized Children - UDR with once daily peanut SLIT-tablet
Biological: Peanut SLIT-tablet
UDR A + maintenance dose A
Biological: Peanut SLIT-tablet
UDR B + maintenance dose B
Biological: Peanut SLIT-tablet
Placebo UDR + placebo maintenance
Other: Placebo
Peanut extract
Placebo
Part 1 and 2: Dose tolerability response rate
The dose tolerability response rate is defined as the percentage of subjects who experience at most moderate local application site reactions after the last peanut SLIT-tablet intake of the dose step. Local application site reactions are treatment-related adverse events occurring in close proximity to the application site of the SLIT-tablet with a temporal relationship to tablet administration.
Time frame: 2 weeks per dose
Part 3: TD-600 response rate
The TD (tolerated dose)-600 response rate is defined as the percentage of subjects able to consume 600 mg (1044 mg cumulative) peanut protein without dose-limiting symptoms at the exit double-blind placebo-controlled food challenge (DBPCFC) after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 1, 2 and 3: Treatment-emergent adverse events
An adverse event is any untoward medical occurrence in a clinical trial subject and which does not necessarily have a causal relationship with the administered investigational medicinal product (IMP). A treatment-emergent adverse event has a start date on or after the time of first IMP intake and no later than 7 days after the last IMP intake.
Time frame: Part 1 and 2: 2 weeks per dose; Part 3: from first IMP intake to 7 days after last IMP intake, up to 48 weeks.
Part 3: TD-300 response rate
The TD-300 response rate is defined as the percentage of subjects able to consume 300 mg (444 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-1000 response rate
The TD-1000 response rate is defined as the percentage of subjects able to consume 1000 mg (2044 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-2000 response rate
The TD-2000 response rate is defined as the percentage of subjects able to consume 2000 mg (4044 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum tolerated dose of peanut protein during DBPCFC
The highest single challenge dose of peanut protein that a subject can consume without experiencing dose-limiting symptoms during the DBPCFC.
Time frame: At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum severity of symptoms at each challenge dose of peanut protein during DBPCFC
The highest severity of any symptom experienced at any challenge dose during the DBPCFC. Possible values are 0=none, 1=mild, 2=moderate or 3=severe.
Time frame: At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Response rate - use of epinephrine as rescue medication during exit DBPCFC
The response rate is defined as the percentage of subjects that receive epinephrine as rescue medication during the exit DBPCFC.
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ALK-Abelló A/S