NCT05163574

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

December 6, 2021

Last Update Submit

July 29, 2023

Conditions

Peanut Allergy

Keywords

peanutfood allergysustained unresponsivenesschildren

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 9 months after starting maintenance phase

  • 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.

    Up to 9 months after starting maintenance phase

Secondary Outcomes (4)

  • Adverse events

    Up to 9 months after starting maintenance phase

  • Occurence of eosinophilic esophagitis.

    Up to 9 months after starting maintenance phase

  • Laboratory data

    Up to 9 months after starting maintenance phase

  • Skin prick test (SPT)

    Up to 9 months after starting maintenance phase

Study Arms (2)

High dose

EXPERIMENTAL

20 patients

Dietary Supplement: High dose OIT

Low dose

ACTIVE COMPARATOR

20 patients

Dietary Supplement: Low dose OIT

Interventions

High dose OITDIETARY_SUPPLEMENT

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

High dose
Low dose OITDIETARY_SUPPLEMENT

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

Low dose

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, Poland

RECRUITING

Related Publications (5)

  • 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: 29307409BACKGROUND

  • 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.

    PMID: 29603410BACKGROUND

  • 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: 30449234BACKGROUND

  • 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.

    PMID: 32314071BACKGROUND

  • 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: 30367908BACKGROUND

MeSH Terms

Conditions

Peanut HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Katarzyna Grzela, MD, PhD

    Medical University of Warsaw

    STUDY CHAIR

Central Study Contacts

Magdalena Chojnowska-Wójtowicz, MD

CONTACT

22-317-9431magdalena.chojnowska@uckwum.pl

Katarzyna Grzela, MD, PhD

CONTACT

22-317-9431katarzyna.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

December 6, 2021

First Posted

December 20, 2021

Study Start

February 5, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)