Food Allergy in ChildrenNCT07592780
Pathway to Peanut Tolerance
A study testing Peanut Oral Immunotherapy (OIT) in people with Food Allergy in Children and Food Allergy Peanut, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Food Allergy in Children, Food Allergy Peanut
- What is being tested?
- Peanut Oral Immunotherapy (OIT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's parent and/ or guardian must be able to understand and provide informed consent.
- Age 2 to 17 years of age
- Either sex
- Any race, any ethnicity
- Have a history of sensitization [positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA/L]
- Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrolment:
Show all 15Show fewer
- Any disorder in which adrenaline is contraindicated (such as hypertension or cardiac rhythm disorders)
- History of chronic diseases requiring therapy (other than asthma, atopic dermatitis, allergic rhinitis)
- Past or current major illness that in the opinion of the Site investigator may affect the subject's ability to participate in the study e.g. increased risk to the participant
- Concurrent treatment with any allergen immunotherapy
- Participation in any trials of therapeutic interventions for FA, or therapy with anti-IgE or other biologics within 1 year of enrolment
- Current uncontrolled or moderate to severe asthma as defined by FEV1 value <80% predicted for participants aged 7 years or older and are able to perform spirometry
- Gastrointestinal eosinophilic disorders
- Use of short-acting antihistamine (e.g. chlorpheniramine) within 3 days prior to open-labelled food challenge or skin testing, or medium-acting antihistamine (e.g. cetirizine, loratadine) within 5 days prior to open-labelled food challenge or skin testing
- Use of beta-blockers, ACE inhibitors, angiotensin-receptor blockers or calcium channel blockers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Paediatrics, Prince of Wales Hospital
Hong Kong
About this study
Official title: A Pragmatic, Open-label Study of Peanut Oral Immunotherapy in Inducing Desensitisation or Remission in Children With Food Allergy Compared to Standard Care (Strict Allergen Avoidance)
While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.
Read the detailed description
This is an open-label, non-randomized, two-arm trial designed to evaluate the real-world efficacy, safety, and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol for children under 18 in Hong Kong. The study addresses a significant unmet need by providing access to a treatment available overseas and aims to establish a translatable model for future food allergy treatments in the region. The intervention arm (n=100) will undergo 18 months of peanut OIT, while the control arm (n=25) will follow standard care, i.e., strict peanut avoidance for the same duration.
Eligible children aged 2-17 with a confirmed peanut allergy will be recruited from the Specialist Outpatient Clinic at the Prince of Wales Hospital and through referral from other public hospitals. Participants will be allocated to the active or control arm in a 4:1 ratio.
The primary efficacy measure is the proportion of participants in the OIT group versus the control group who achieve a desensitization level of more than 640 mg of peanut protein, as confirmed by an oral food challenge at the end of the 18-month treatment period.
Some of the key secondary objectives include to systematically document the frequency and severity of treatment-related adverse events and the proportion of participants discontinuing OIT due to these events; and to identify distinct pre- and post-treatment plasma protein biomarkers associated with successful OIT.
- Conditions
- Food Allergy in Children, Food Allergy Peanut
- Being tested
- Peanut Oral Immunotherapy (OIT)
- Keywords
- food allergy, peanut allergy, oral immunotherapy
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut Oral Immunotherapy (OIT)Dietary supplement
This study uses a commercially available, standardized defatted peanut powder as its active intervention
| Study group | Role | What they receive |
|---|---|---|
| Peanut Oral Immunotherapy | Active comparator | Not described Receives: Dietary Supplement: Peanut Oral Immunotherapy (OIT) |
| Peanut Avoidance | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitization Rate at EOT
Proportion of participants with a peanut eliciting dose >640 mg protein at end-of-treatment (EOT) in OIT vs control groups.
Measured: EOT (18 months)
Secondary outcomes (1)
Safety During Treatment
Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in active vs control group
Measured: Baseline to EOT (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start15 Nov 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a prospective, open-label, non-randomized, two-arm parallel-group design to evaluate peanut oral immunotherapy (OIT) in a real-world Hong Kong pediatric population. Ninety participants will be allocated in a 4:1 ratio to either an 18-month pragmatic OIT protocol (n=100) or a standard care control group maintaining strict avoidance (n=25). As a pragmatic trial, it focuses on effectiveness and safety under routine clinical conditions rather than ideal settings. The open-label design reflects the interventional nature of the treatment, where blinding is not feasible. This model aims to generate crucial local evidence on protocol feasibility, tolerability, and clinical outcomes to inform future regional allergy care strategies.
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Sze-Yin Leung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592780
- Sponsor's protocol ID
- P3T01
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The potential sharing of IPD is currently under careful consideration by the institutional review board and research ethics committee. A final decision will depend on several factors, including: 1) compliance with local data protection regulations and institutional policies in Hong Kong, 2) ensuring adequate de-identification of participant data given the relatively small and potentially identifiable patient population, and 3) alignment with the specific consent obtained from participants regarding data sharing. We are committed to responsible data stewardship while maximizing the scientific value of this research, and will make a definitive determination before study completion.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Open-label Study of Peanut Oral Immunotherapy in Inducing Desensitisation or Remission in Children With Food Allergy Compared to Standard Care (Strict Allergen Avoidance)
- ClinicalTrials.gov ID
- NCT07592780
- Acronym / sponsor ID
- P3T01
- Conditions
- Food Allergy in Children, Food Allergy Peanut
- Keywords
- food allergy, peanut allergy, oral immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2026 (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.
While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.
Detailed description
This is an open-label, non-randomized, two-arm trial designed to evaluate the real-world efficacy, safety, and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol for children under 18 in Hong Kong. The study addresses a significant unmet need by providing access to a treatment available overseas and aims to establish a translatable model for future food allergy treatments in the region. The intervention arm (n=100) will undergo 18 months of peanut OIT, while the control arm (n=25) will follow standard care, i.e., strict peanut avoidance for the same duration.
Eligible children aged 2-17 with a confirmed peanut allergy will be recruited from the Specialist Outpatient Clinic at the Prince of Wales Hospital and through referral from other public hospitals. Participants will be allocated to the active or control arm in a 4:1 ratio.
The primary efficacy measure is the proportion of participants in the OIT group versus the control group who achieve a desensitization level of more than 640 mg of peanut protein, as confirmed by an oral food challenge at the end of the 18-month treatment period.
Some of the key secondary objectives include to systematically document the frequency and severity of treatment-related adverse events and the proportion of participants discontinuing OIT due to these events; and to identify distinct pre- and post-treatment plasma protein biomarkers associated with successful OIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a prospective, open-label, non-randomized, two-arm parallel-group design to evaluate peanut oral immunotherapy (OIT) in a real-world Hong Kong pediatric population. Ninety participants will be allocated in a 4:1 ratio to either an 18-month pragmatic OIT protocol (n=100) or a standard care control group maintaining strict avoidance (n=25). As a pragmatic trial, it focuses on effectiveness and safety under routine clinical conditions rather than ideal settings. The open-label design reflects the interventional nature of the treatment, where blinding is not feasible. This model aims to generate crucial local evidence on protocol feasibility, tolerability, and clinical outcomes to inform future regional allergy care strategies.
| Arm | Type | Receives |
|---|---|---|
| Peanut Oral Immunotherapy | Active comparator | Dietary Supplement: Peanut Oral Immunotherapy (OIT) |
| Peanut Avoidance | No intervention | – |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Subject's parent and/ or guardian must be able to understand and provide informed consent.
- Age 2 to 17 years of age
- Either sex
- Any race, any ethnicity
- Have a history of sensitization [positive skin prick test to peanut extract as defined by wheal size at least 3mm above control OR peanut-specific IgE ≥0.35 kUA/L]
Key exclusion criteria (0 listed)
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 Oral Immunotherapy (OIT)This study uses a commercially available, standardized defatted peanut powder as its active intervention | Dietary supplement | Peanut Oral Immunotherapy |
Primary outcome
Desensitization Rate at EOT
Time frame: EOT (18 months)
Proportion of participants with a peanut eliciting dose >640 mg protein at end-of-treatment (EOT) in OIT vs control groups.
1 secondary outcome
Safety During Treatment
Time frame: Baseline to EOT (18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided. The potential sharing of IPD is currently under careful consideration by the institutional review board and research ethics committee. A final decision will depend on several factors, including: 1) compliance with local data protection regulations and institutional policies in Hong Kong, 2) ensuring adequate de-identification of participant data given the relatively small and potentially identifiable patient population, and 3) alignment with the specific consent obtained from participants regarding data sharing. We are committed to responsible data stewardship while maximizing the scientific value of this research, and will make a definitive determination before study completion.
Related trials for Food Allergy in Children
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
Not yet recruiting
Oral Immunotherapy for Children With Egg Allergy
Egg Allergy, Egg Hypersensitivity
Not yet recruiting
Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy
Food Allergy in Children
Not yet recruiting
A Randomized Controlled Trial of Oral Immunotherapy Versus Allergen Avoidance in Children Under 2 Years With Food Allergy
Food Allergy in Children, Oral Immunotherapy for Food Allergy
RecruitingObservational study
The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study
Food Allergy in Children
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Oral Immunotherapy (OIT) in people with Food Allergy in Children and Food Allergy Peanut, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 15 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 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 1 site in Hong Kong. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sze Yin Agnes Leung, MBChB (+85235052859, agnes.syl@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitization Rate at EOT (time frame: EOT (18 months)). 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 19 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.