Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study

NCT03345160 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00150453
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. As part this protocol, all participants who received placebo treatment were promised the opportunity to receive open label treatment at the conclusion of the double-blind phase and initial follow-up. At the time of submitting that protocol, the investigator did not specify any detailed protocol for the open label crossover treatment, as this is an evolving field, but the investigator is now ready to offer this open label treatment as promised.

Conditions

Treatment Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-related Adverse Events (AEs)

  Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.

  up to 52 weeks

Secondary Outcomes (1)

• Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge

  up to 52 weeks

Study Arms (1)

Peanut Flour: Open label peanut OIT

EXPERIMENTAL

This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study

Drug: Peanut Flour

Interventions

Peanut Flour DRUG

open label oral immunotherapy

Also known as: Peanut Oral Immunotherapy

Peanut Flour: Open label peanut OIT

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
• Subjects who were randomized to the placebo arm of protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children."
• Parent guardian must be able to understand and provide informed consent
• Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut protein during the End-of-Treatment food challenge from Protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children"

You may not qualify if:

• Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
• Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol
• History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension, neurological compromise, confusion, cardiovascular collapse, or loss of consciousness
• Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis) requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the investigator to have potential impact on study outcomes or safety.
• Severe or poorly controlled atopic dermatitis per investigator's discretion
• Past or current history of eosinophilic gastrointestinal disease
• Diagnosis of asthma that meets any of the following criteria:
• Uncontrolled asthma (as per Global Initiative for Asthma \[GINA\] latest guidelines)
• History of 2 or more systemic corticosteroid courses or 1 systemic course within the 3 previous months prior to visit 1 for treating wheezing
• Prior intubation/mechanical ventilation for asthma
• Currently receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
• Current participation in another clinical trial or participation in another clinical trial in the last 90 days

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jan 30. doi: 10.1111/imm.70098. Online ahead of print.

  PMID: 41615410 DERIVED

• Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.

  PMID: 35065784 DERIVED

Results Point of Contact

• Title: Dr. Robert Wood
• Organization: Johns Hopkins School of Medicine

RWood@JHMI.edu

410-919-7617

Study Officials

• Robert Wood, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label crossover

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: April 27, 2018
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)