Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy

NCT07107451 | Not Yet Recruiting DMC

• 1 other identifier: KB/60/2025
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:

• First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks).
• Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks). After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Conditions

Food Allergy in Children

Keywords

sesame allergy; oral immunotherapy; sustained unresponsiveness (SU)

Outcome Measures

Primary Outcomes (1)

• Sustained unresponsiveness determined by the outcome of the OFC

  Percentage of patients achieving sustained unresponsiveness after low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

Secondary Outcomes (16)

• Changes in sesame protein tolerance during OFC

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Adverse event

  11 months on the maintenance dose of OIT (±3 weeks) and a 4 week break (+/- 7 days).

• Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Basophil activation test (BAT)

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

• Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - wheal diameter in PTS

  After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).

Study Arms (2)

Maintenance dose of sesame protein (300mg) for 8 months

EXPERIMENTAL

Patients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of sesame protein (300mg) for the next 8 months.

Dietary Supplement: OIT with low dose sesame protein

Immunotherapy initiated after one year of sesame avoidance

EXPERIMENTAL

Patients assigned to the control group in the first part of the study, after one year on a sesame elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months.

Dietary Supplement: OIT with low dose sesame protein

Interventions

OIT with low dose sesame protein DIETARY_SUPPLEMENT

After 8 months of continued low-dose sesame OIT, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to evaluate desensitization. Patients who had a negative OFC after 3 months in the initial phase of the study-and thus confirmed desensitization-will skip the pre-break OFC and proceed directly to the next stage. Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to assess sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed at this visit.

Immunotherapy initiated after one year of sesame avoidance; Maintenance dose of sesame protein (300mg) for 8 months

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sesame allergy confirmed before starting immunotherapy
• Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
• Obtaining informed consent to participate in the study,
• Patient/carer cooperation.

You may not qualify if:

• Severe asthma,
• Mild/moderate poorly controlled asthma: FEV1\<80% (under 5. percentile), FEV1/FVC\<75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,
• Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
• Eosinophilic gastroenteritis,
• Severe, recurrent episodes of anaphylaxis within the last 6 months,
• Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
• Taking medication:
• oral, daily steroid therapy \>1 month in the past 12 months,
• At least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
• One oral steroid therapy (min. 7 days) in the last 3 months,
• biological treatment,
• therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors,
• Pregnancy,
• No consent to participate in the study,
• Lack of cooperation from the patient.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (8)

• Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.

  PMID: 28065342 BACKGROUND

• 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.

  PMID: 23195525 BACKGROUND

• Rodriguez Del Rio P, Escudero C, Sanchez-Garcia S, Ibanez MD, Vickery BP. Evaluating primary end points in peanut immunotherapy clinical trials. J Allergy Clin Immunol. 2019 Feb;143(2):494-506. doi: 10.1016/j.jaci.2018.09.035. Epub 2018 Oct 24.

  PMID: 30367908 BACKGROUND

• Shah A, Cox AL, Groetch M, Kattan JD, Schaible A, Sicherer SH, Tsuang A, Wang J, Oriel RC. Sesame oral immunotherapy outcomes in a pediatric cohort. J Allergy Clin Immunol Pract. 2025 Apr;13(4):938-940.e1. doi: 10.1016/j.jaip.2025.01.036. Epub 2025 Feb 8. No abstract available.

  PMID: 39929303 BACKGROUND

• 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.

  PMID: 29307409 BACKGROUND

• 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.

  PMID: 29205393 BACKGROUND

• 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.

  PMID: 28490893 BACKGROUND

• 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.

  PMID: 22610362 BACKGROUND

Central Study Contacts

Katarzyna Grzela, MD, PhD

CONTACT

+48 22 3179431; katarzyna.grzela@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

PL (1)