High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety

NCT04415593 | Completed DMC

• 1 other identifier: Peanuts protocol
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.

Conditions

Peanut Allergy

Keywords

peanuts; food allergy; immunotherapy; children

Outcome Measures

Primary Outcomes (1)

• Tolerance of peanuts

  Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein

  Up to 16 months after starting oral immunotherapy

Secondary Outcomes (3)

• Adverse event

  Up to 16 months after starting oral immunotherapy

• Laboratory data

  Up to 16 months after starting oral immunotherapy

• Skin prick test (SPT)

  Up to 16 months after starting oral immunotherapy

Study Arms (2)

high dose of peanut

EXPERIMENTAL

20 patients

Dietary Supplement: High dose of peanuts

low dose of peanuts

ACTIVE COMPARATOR

20 patients

Dietary Supplement: Low dose of peanuts

Interventions

High dose of peanuts DIETARY_SUPPLEMENT

Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

high dose of peanut

Low dose of peanuts DIETARY_SUPPLEMENT

Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

low dose of peanuts

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• medical history of peanut allergy,
• IgE-mediated peanut allergy confirmed as positive skin prick tests with peanut allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
• reaction to less than 100 mg of peanut protein during OOFC,
• signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
• patient's/caregivers' cooperation with researcher.

You may not qualify if:

• no confirmed peanut allergy,
• negative oral food challenge with less than 100mg of peanut protein,
• severe asthma,
• uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
• current oral/sublingual/subcutaneous immunotherapy with other allergen,
• eosinophilic gastroenteritis,
• a history of severe recurrent anaphylaxis episodes,
• chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
• medication:
• oral, daily steroid therapy longer than 1 month within last 12 months,
• at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
• oral steroid therapy longer than 7 days within last 3 months,
• biological treatment,
• the need to constantly take antihistamines,
• therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (7)

• 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

• Stiefel G, Anagnostou K, Boyle RJ, Brathwaite N, Ewan P, Fox AT, Huber P, Luyt D, Till SJ, Venter C, Clark AT. BSACI guideline for the diagnosis and management of peanut and tree nut allergy. Clin Exp Allergy. 2017 Jun;47(6):719-739. doi: 10.1111/cea.12957.

  PMID: 28836701 BACKGROUND

• PALISADE Group of Clinical Investigators; Vickery BP, Vereda A, Casale TB, Beyer K, du Toit G, Hourihane JO, Jones SM, Shreffler WG, Marcantonio A, Zawadzki R, Sher L, Carr WW, Fineman S, Greos L, Rachid R, Ibanez MD, Tilles S, Assa'ad AH, Nilsson C, Rupp N, Welch MJ, Sussman G, Chinthrajah S, Blumchen K, Sher E, Spergel JM, Leickly FE, Zielen S, Wang J, Sanders GM, Wood RA, Cheema A, Bindslev-Jensen C, Leonard S, Kachru R, Johnston DT, Hampel FC Jr, Kim EH, Anagnostou A, Pongracic JA, Ben-Shoshan M, Sharma HP, Stillerman A, Windom HH, Yang WH, Muraro A, Zubeldia JM, Sharma V, Dorsey MJ, Chong HJ, Ohayon J, Bird JA, Carr TF, Siri D, Fernandez-Rivas M, Jeong DK, Fleischer DM, Lieberman JA, Dubois AEJ, Tsoumani M, Ciaccio CE, Portnoy JM, Mansfield LE, Fritz SB, Lanser BJ, Matz J, Oude Elberink HNG, Varshney P, Dilly SG, Adelman DC, Burks AW. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001. doi: 10.1056/NEJMoa1812856. Epub 2018 Nov 18.

  PMID: 30449234 BACKGROUND

• Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group. Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. J Allergy Clin Immunol Pract. 2018 Mar-Apr;6(2):476-485.e3. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.

  PMID: 29092786 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

• Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.

  PMID: 16597075 BACKGROUND

• 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

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Klementyna Łyżwa, MD

  Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low (150mg) and high (300mg) dose of peanut protein in children randomly assigned to two groups (1:1). Patients will receive ground peanuts mixed with apple mousse (supposing apple tolerance). For the transparency of the study all patients will receive the same commercially prepared apple muss product.

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2020
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 8, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)