Clinical trial NCT05923216: Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy
Official title: Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy - Evaluation of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Food Allergy
Keywords: sesame
food allergy
sustained unresponsiveness
children
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved (High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety, NCT05158413).

The aim of this study is to assess a sustained unresponsiveness (SU) to sesame protein after at least 8 months of previously assigned high- or low-dose sesame OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Detailed description: Oral immunotherapy is considered the most effective treatment for food allergy. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness.

Desensitisation involves achieving temporary tolerance of the allergenic food by the patient only during regular intake of the allergen. The most desirable effect of immunotherapy is to achieve sustained unresponsiveness, i.e. to maintain the absence of adverse symptoms to a given allergen after specific immunotherapy has been discontinued for a defined period of time.

The study is a continuation of a clinical trial NCT05158413 which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of sesame protein (300 or 1200 mg, respectively) in children with a confirmed diagnosis of sesame 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 sesame allergen, which was used in previous trial (300 or 1200 mg, respectively), for 32 weeks (+/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict sesame avoidance. Subsequently, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.

Eligibility criteria: Inclusion Criteria:

* patients who have accomplished their per-protocol participation in trial NCT05158413.
* 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

Primary outcomes:
measure: Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.
timeFrame: Up to 9 months after starting maintenance phase
measure: The highest tolerated dose of sesame protein after discontinuing oral immunotherapy for 4 weeks.
timeFrame: Up to 9 months after starting maintenance phase
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 9 months after starting maintenance phase
measure: Laboratory data
timeFrame: Up to 9 months after starting maintenance phase
measure: Skin prick test (SPT)
timeFrame: Up to 9 months after starting maintenance phase
measure: Tolerance of a single dose of 4000 mg of sesame protein
timeFrame: Up to 9 months after starting maintenance phase
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Katarzyna Grzela, PhD, MD
role: STUDY_CHAIR
References:
citation: Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.
citation: Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
citation: Adatia A, Clarke AE, Yanishevsky Y, Ben-Shoshan M. Sesame allergy: current perspectives. J Asthma Allergy. 2017 Apr 27;10:141-151. doi: 10.2147/JAA.S113612. eCollection 2017.
citation: Burks AW, Sampson HA, Plaut M, Lack G, Akdis CA. Treatment for food allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. doi: 10.1016/j.jaci.2017.11.004.
citation: Nachshon L, Goldberg MR, Levy MB, Appel MY, Epstein-Rigbi N, Lidholm J, Holmqvist M, Katz Y, Elizur A. Efficacy and Safety of Sesame Oral Immunotherapy-A Real-World, Single-Center Study. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2775-2781.e2. doi: 10.1016/j.jaip.2019.05.031. Epub 2019 May 29.
citation: Dalal I, Goldberg M, Katz Y. Sesame seed food allergy. Curr Allergy Asthma Rep. 2012 Aug;12(4):339-45. doi: 10.1007/s11882-012-0267-2.