Peanut AllergyPhase 1/2NCT05440643
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
A Phase 1/2 study testing Peanut SLIT-tablet in people with Peanut Allergy, run by ALK-Abelló A/S at 42 sites in 2 countries.
Trial summary
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut SLIT-tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 42 sitesin 2 countries
- Study dates
- 7 Sep 2022to 5 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects are eligible to be included in the trial only if all the following criteria apply:
- Part 1: Male or female aged 12 through 65 years (inclusive) on the day of enrollment Part 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollment Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization
- Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
- Peanut-specific serum IgE ≥ 0.7 kU/L at screening measured at central laboratory
- Skin prick test to peanut ≥ 5 mm at screening
- Cohorts 1-8: Experience dose-limiting symptoms at the 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC
Who cannot join
- Subjects are excluded from the trial if any of the following criteria apply:
- Diagnosis or history of eosinophilic esophagitis
- Uncontrolled asthma as defined by the Asthma Control Test questionnaire with a score of 19 or below at enrollment (subjects with a diagnosis of asthma only)
- All subjects ≥ 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment
- Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed
- History of peanut oral immunotherapy within the last 12 months prior to visit 1
Show all 27Show fewer
- Chronic or acute oral inflammation at enrollment
- History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- Currently using any prohibited medication on the list of prohibited medication
- Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screening DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC
- History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC
- Part 1 and 2: Asthma according to below criteria:
- Severe asthma as per the current GINA guidelines
- Uncontrolled or poorly controlled asthma as per the current GINA guidelines
- Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids)
- History of 2 or more systemic corticosteroid courses within 6 months of screening
- Prior intubation/mechanical ventilation for asthma
- Emergency room visit or hospitalization for asthma in the 12 months prior to screening
- Any history of a life-threatening asthma attack
- Part 3: Asthma fulfilling the below criteria:
- History of 2 or more systemic corticosteroid courses within 6 months of screening
- Prior intubation/mechanical ventilation for asthma
- Emergency room visit or hospitalization for asthma in the 12 months prior to screening
- Any history of a life-threatening asthma attack
- (US only) Severe asthma as per the current GINA guidelines
- (US only) Uncontrolled or poorly controlled asthma as per the current GINA guidelines
- (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States33 sites
University of Michigan
Ann Arbor, Michigan, 48109
Center for Advance Pediatrics
Atlanta, Georgia, 30329
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0005
Boston Food Allergy Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
Ann Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611-2605
Rush University
Chicago, Illinois, 60612
Aventiv research, Inc
Columbus, Ohio, 43212
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Western Sky Medical Research
El Paso, Texas, 79903
Northwell Health
Great Neck, New York, 11021
Quality Research of South Florida
Hialeah, Florida, 33016
Baylor College of Medicine (BCM) Texas Children's Hospital Pediatrics and Immunology
Houston, Texas, 77030
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Children's Hospital of Los Angeles - USC School of Medicine
Los Angeles, California, 90027
UCLA - Pediatrics
Los Angeles, California, 90095
Family Allergy Asthma Research Institute
Louisville, Kentucky, 40215-1176
NYU Langone Health - Fink Children's Ambulatory Care Center
New York, New York, 10016
Icahn School of Medicine at Mt. Sinai, Pediatric Allergy, Kravis Children Hospital
New York, New York, 10029
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, 61761
Allergy Partners of NJ
Ocean City, New Jersey, 07712
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, 94304
Children's Hospital of Philadephia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburg of UPMC - Immunology and Rheumatology
Pittsburgh, Pennsylvania, 15224
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274
Eastern Virginia Medical School - Children's Hospital
San Diego, California, 92123
MOORE-PH Dermatology - Clinical Research
Tampa, Florida, 33609
USF Asthma Allergy and Immunology Clinical Research Unit
Tampa, Florida, 33609
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
Asthma, Allergy and Sinus Center
White Marsh, Maryland, 21162
Canada9 sites
Halton Pediatric Allergy
Burlington, Ontario, L7L 6W6
Hamilton Allergy
Hamilton, Ontario
McGill University Health Centre (MUHC) - Research Institute (RI-MUHC)
Montreal, Quebec, H3H 2R9
CHU-Saint-Justine
Montreal, Quebec, H3T 1C5
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1H 1E4
Clinique Specialisee en Allergie de la Capitale
Québec, G1V 4W2
The Hospital for Sick Children, Toronto
Toronto, Ontario, M5G 1E8
BC Children's Hospital
Vancouver, British Colombia, V5H 3V4
The Children's Hospital Foundation of Manitoba
Winnipeg, Manitoba, R3A 1M3
About this study
Official title: A Phase I/II Trial in 3 Parts Assessing the Safety, Tolerability, and Efficacy of a Once-daily Peanut Sublingual Immunotherapy (SLIT) Tablet in Adults, Adolescents, and Children With Peanut Allergy
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
Read the detailed description
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.
- Conditions
- Peanut Allergy
- Being tested
- Peanut SLIT-tablet, Placebo
- Keywords
- Peanut allergy, Children, Adolescent, Adult
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut SLIT-tabletBiological
Peanut extract
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Receives: Biological: Peanut SLIT-tablet |
| Part 1: Cohort 2 | Experimental | Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Receives: Biological: Peanut SLIT-tablet |
| Part 1: Cohort 3 | Experimental | Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Receives: Biological: Peanut SLIT-tablet |
| Part 1: Cohort 4 | Experimental | Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Receives: Biological: Peanut SLIT-tablet |
| Part 1: Cohort 5 | Experimental | Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Receives: Biological: Peanut SLIT-tablet |
| Part 2: Cohort 6 | Experimental | Adults - UDR with once daily peanut SLIT-tablet Receives: Biological: Peanut SLIT-tablet |
| Part 2: Cohort 7 | Experimental | Adolescents - UDR with once daily peanut SLIT-tablet Receives: Biological: Peanut SLIT-tablet |
| Part 2: Cohort 8 | Experimental | Children - UDR with once daily peanut SLIT-tablet Receives: Biological: Peanut SLIT-tablet |
| Part 2: Cohort 9 | Experimental | Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet Receives: Biological: Peanut SLIT-tablet |
| Part 2: Cohort 10 | Experimental | Highly sensitized Children - UDR with once daily peanut SLIT-tablet Receives: Biological: Peanut SLIT-tablet |
| Part 3: Maintenance A | Experimental | UDR A + maintenance dose A Receives: Biological: Peanut SLIT-tablet |
| Part 3: Maintenance B | Experimental | UDR B + maintenance dose B Receives: Biological: Peanut SLIT-tablet |
| Part 3: Placebo | Placebo comparator | Placebo UDR + placebo maintenance Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 24 weeks of maintenance treatment, up to 48 weeks.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 24 weeks of maintenance treatment, up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start7 Sep 2022
- Primary completion10 Mar 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 and 2 is sequential Part 3 is parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Edwin Kim, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440643
- Sponsor's protocol ID
- PT-01
- Status last verified
- May 2026
- First submitted
- 17 Jun 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial in 3 Parts Assessing the Safety, Tolerability, and Efficacy of a Once-daily Peanut Sublingual Immunotherapy (SLIT) Tablet in Adults, Adolescents, and Children With Peanut Allergy
- ClinicalTrials.gov ID
- NCT05440643
- Acronym / sponsor ID
- PT-01
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergy, Children, Adolescent, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
- Model description
- Part 1 and 2 is sequential Part 3 is parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 | Experimental | Biological: Peanut SLIT-tabletAdults and adolescents - peanut SLIT-tablet once daily for 2 weeks |
| Part 1: Cohort 2 | Experimental | Biological: Peanut SLIT-tabletAdults and adolescents - peanut SLIT-tablet once daily for 2 weeks |
| Part 1: Cohort 3 | Experimental | Biological: Peanut SLIT-tabletAdults and adolescents - peanut SLIT-tablet once daily for 2 weeks |
| Part 1: Cohort 4 | Experimental | Biological: Peanut SLIT-tabletAdults and adolescents - peanut SLIT-tablet once daily for 2 weeks |
| Part 1: Cohort 5 | Experimental | Biological: Peanut SLIT-tabletAdults and adolescents - peanut SLIT-tablet once daily for 2 weeks |
| Part 2: Cohort 6 | Experimental | Biological: Peanut SLIT-tabletAdults - UDR with once daily peanut SLIT-tablet |
| Part 2: Cohort 7 | Experimental | Biological: Peanut SLIT-tabletAdolescents - UDR with once daily peanut SLIT-tablet |
| Part 2: Cohort 8 | Experimental | Biological: Peanut SLIT-tabletChildren - UDR with once daily peanut SLIT-tablet |
| Part 2: Cohort 9 | Experimental | Biological: Peanut SLIT-tabletHighly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet |
| Part 2: Cohort 10 | Experimental | Biological: Peanut SLIT-tabletHighly sensitized Children - UDR with once daily peanut SLIT-tablet |
| Part 3: Maintenance A | Experimental | Biological: Peanut SLIT-tabletUDR A + maintenance dose A |
| Part 3: Maintenance B | Experimental | Biological: Peanut SLIT-tabletUDR B + maintenance dose B |
| Part 3: Placebo | Placebo comparator | Other: PlaceboPlacebo UDR + placebo maintenance |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects are eligible to be included in the trial only if all the following criteria apply:
- Part 1: Male or female aged 12 through 65 years (inclusive) on the day of enrollment Part 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollment Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization
- Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
- Peanut-specific serum IgE ≥ 0.7 kU/L at screening measured at central laboratory
- Skin prick test to peanut ≥ 5 mm at screening
Key exclusion criteria (27 listed)
- Diagnosis or history of eosinophilic esophagitis
- Uncontrolled asthma as defined by the Asthma Control Test questionnaire with a score of 19 or below at enrollment (subjects with a diagnosis of asthma only)
- All subjects ≥ 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment
- Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed
- History of peanut oral immunotherapy within the last 12 months prior to visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut SLIT-tabletPeanut extract | Biological | Part 1: Cohort 1, Part 1: Cohort 2, Part 1: Cohort 3, Part 1: Cohort 4, Part 1: Cohort 5, Part 2: Cohort 10, Part 2: Cohort 6, Part 2: Cohort 7, Part 2: Cohort 8, Part 2: Cohort 9, Part 3: Maintenance A, Part 3: Maintenance B |
| PlaceboPlacebo | Other | Part 3: Placebo |
Primary outcome
Part 1 and 2: Dose tolerability response rate
Time frame: 2 weeks per dose
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.
Part 3: TD-600 response rate
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
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.
7 secondary outcomes
Part 1, 2 and 3: Treatment-emergent adverse events
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
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-1000 response rate
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-2000 response rate
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum tolerated dose of peanut protein during 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
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
Time frame: After 24 weeks of maintenance treatment, up to 48 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Kim, MD principal investigator
University of North Carolina
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peanut SLIT-tablet in people with Peanut Allergy, run by ALK-Abelló A/S at 42 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and 2: Dose tolerability response rate (time frame: 2 weeks per dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.