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

Primary Purpose

Peanut Allergy

Status

Recruiting

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

High dose OIT

Low dose OIT

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring peanut, food allergy, sustained unresponsiveness, children

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Pediatric Pneumonology and Allergy, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose

Low dose

Arm Description

20 patients

Outcomes

Primary Outcome Measures

Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.

The share of participants who tolerate a single dose of 150 mg or 300 mg of peanut protein (depending on the maintenance dose) at oral food challenge.

The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.

Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.

Secondary Outcome Measures

Adverse events

Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.

Occurence of eosinophilic esophagitis.

Number and severity of eosinophilic esophagitis symptoms following OIT treatment assessed and compared between both groups.

Laboratory data

Change in serum levels of specific immunoglobulin E (sIgE) to peanut components and peanut-specific immunoglobulin G4 (sIgE4) levels at different time points: at the start and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.

Skin prick test (SPT)

Change in peanut skin prick test wheal in different time points: at the start, and at the end of oral immunotherapy, and after 4 weeks of allergen avoidance, assessed for each individual and compared between groups.

Full Information

NCT ID

NCT05163574

First Posted

December 6, 2021

Last Updated

July 29, 2023

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT05163574

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

peanut, food allergy, sustained unresponsiveness, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High dose

Arm Type

Experimental

Arm Description

20 patients

Arm Title

Low dose

Arm Type

Active Comparator

Arm Description

20 patients

Intervention Type

Dietary Supplement

Intervention Name(s)

High dose OIT

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Low dose OIT

Intervention Description

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

Primary Outcome Measure Information:

Title

Sustained unresponsiveness to a peanut protein after discontinuing oral immunotherapy for 4 weeks.

Description

The share of participants who tolerate a single dose of 150 mg or 300 mg of peanut protein (depending on the maintenance dose) at oral food challenge.

Time Frame

Up to 9 months after starting maintenance phase

Title

The highest tolerated dose of peanut protein after discontinuing oral immunotherapy for 4 weeks.

Description

Sustained unresponsiveness assessed as the highest tolerated dose of peanut protein at oral food challenge.

Time Frame

Up to 9 months after starting maintenance phase

Secondary Outcome Measure Information:

Title

Adverse events

Description

Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.

Time Frame

Up to 9 months after starting maintenance phase

Title

Occurence of eosinophilic esophagitis.

Description

Number and severity of eosinophilic esophagitis symptoms following OIT treatment assessed and compared between both groups.

Time Frame

Up to 9 months after starting maintenance phase

Title

Laboratory data

Description

Time Frame

Up to 9 months after starting maintenance phase

Title

Skin prick test (SPT)

Description

Time Frame

Up to 9 months after starting maintenance phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Magdalena Chojnowska-Wójtowicz, MD

Phone

22-317-9431

magdalena.chojnowska@uckwum.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Katarzyna Grzela, MD, PhD

Phone

22-317-9431

katarzyna.grzela@wum.edu.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katarzyna Grzela, MD, PhD

Organizational Affiliation

Medical University of Warsaw

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

City

Warsaw

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wioletta Zagórska, PhD, MD

wiola.zagorska@gmail.com

First Name & Middle Initial & Last Name & Degree

Magdalena Chojnowska-Wójtowicz, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29307409

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.

Results Reference

background

PubMed Identifier

29603410

Citation

Nagakura KI, Yanagida N, Sato S, Nishino M, Asaumi T, Ogura K, Ebisawa M. Low-dose oral immunotherapy for children with anaphylactic peanut allergy in Japan. Pediatr Allergy Immunol. 2018 Aug;29(5):512-518. doi: 10.1111/pai.12898. Epub 2018 May 10.

Results Reference

background

PubMed Identifier

30449234

Citation

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.

Results Reference

background

PubMed Identifier

32314071

Citation

Patrawala M, Shih J, Lee G, Vickery B. Peanut Oral Immunotherapy: a Current Perspective. Curr Allergy Asthma Rep. 2020 Apr 20;20(5):14. doi: 10.1007/s11882-020-00908-6.

Results Reference

background

PubMed Identifier

30367908

Citation

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.

Results Reference

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

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