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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Desensitization Rate at EOT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •Individuals who meet any of these criteria are not eligible for enrolment:
- •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
研究组 & 干预措施
Peanut Avoidance
Peanut Oral Immunotherapy
干预措施: Peanut Oral Immunotherapy (OIT) (Dietary Supplement)
结局指标
主要结局
Desensitization Rate at EOT
时间窗: EOT (18 months)
Proportion of participants with a peanut eliciting dose \>640 mg protein at end-of-treatment (EOT) in OIT vs control groups.
次要结局
- Safety During Treatment(Baseline to EOT (18 months))
研究者
Agnes Sze-Yin Leung
Prof. Agnes S.Y. Leung
Chinese University of Hong Kong