Induction of Sustained Unresponsiveness to Peanuts Using High- and Low-dose Peanut Oral Immunotherapy

Study Purpose

This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial. The aim of current study is to assess a sustained unresponsiveness (SU) to allergen protein after at least 8 months of previously assigned high- or low-dose peanut OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- patients who have accomplished their per-protocol participation in trial NCT044155930.

- signed Informed Consent by parent/legal guardian and patient aged>16 years old.

- patient's/caregiver's cooperation with researcher.

Exclusion Criteria:

- severe asthma.

- uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5 percentile), FEV1/forced vital capacity (FEV)<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months.

- current oral/sublingual/subcutaneous immunotherapy with another allergen.

- eosinophilic esophagitis.

- allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy.

- a history of severe recurrent anaphylaxis episodes.

- chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes.

- medication: - oral, daily steroid therapy exceeding 1 month within the last 12 months.

- at least two courses of oral steroid therapy (at least 7 days) within the last 12 months.

- oral steroid therapy longer than 7 days within the last 3 months.

- biological treatment.

- the need to constantly take antihistamines.

- therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors.

- pregnancy.

- no consent to participate in the study.

- lack of patient cooperation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05163574
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Warsaw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Katarzyna Grzela, MD, PhD
Principal Investigator Affiliation	Medical University of Warsaw
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Additional Details

Oral immunotherapy is considered the most effective food allergy treatment. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness. Desensitization is a temporary state of clinical non-reactivity which requires regular intake of allergen, whereas sustained unresponsiveness is defined as lack of clinical reaction to a food allergen after discontinuing OIT for a specific period of time. The study is a continuation of a clinical trial NCT044155930, which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) in children with a confirmed diagnosis of peanut allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial. Patients will receive the same maintenance dose of peanut allergen, which was used in previous trial (150 or 300 mg, respectively), for at least 8 months (32 weeks +/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict peanut avoidance. After this period, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.

Arms & Interventions

Arms

Experimental: High dose

20 patients

Active Comparator: Low dose

20 patients

Interventions

Dietary Supplement: - High dose OIT

Patients will receive daily a high dose of peanut flour (300 mg peanut protein) mixed with well-tolerated fruit mousse.

Dietary Supplement: - Low dose OIT

Patients will receive daily a low dose of peanut flour (150 mg peanut protein) mixed with well-tolerated fruit mousse.

Contact a Trial Team

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International Sites

Warsaw, Poland

Status

Recruiting

Address

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, ,

Site Contact

Wioletta Zagórska, PhD, MD

[email protected]

22-317-9431

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