Phase 2 N=41 Randomized Triple-blind Basic Science

Tolerance Following Peanut Oral Immunotherapy

Peanut Allergy

Bottom Line

View on ClinicalTrials.gov: NCT01750879 ↗

Enrolled (actual)

Serious AEs

2.4%

Results posted

Jul 2021

Primary outcome: Primary: Tolerance, Partial Tolerance, or Treatment Failure — 5; 0; 8; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Peanut Flour (Drug); Oat Flour (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Tolerance, Partial Tolerance, or Treatment Failure	5; 0; 8; 0; 7; 8	—
SECONDARY Clinical: Tolerance	4000	—
SECONDARY Clinical: Desensitization	4000; -65	—
SECONDARY Clinical: Safety	0; 0	—
SECONDARY Mechanistic: TCR Clonal Diversity	0.010499258; 0.003841910; 0.003090797; 0.003592776	—
SECONDARY Mechanistic: Change Eliciting Dose of End-point Dilution.	—	—
SECONDARY Mechanistic: Change in Basophil Eliciting Dose.	—	—
SECONDARY Mechanistic: Change in Peanut Allergen-specific IgG4	0.664; 0.375	—
SECONDARY Mechanistic: Significant Gene Expression Changes by Transcriptional Profiling of Regulatory and Effector T Cell Populations	86; 45; 12; 9; 42; 14	—

Summary

The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is thought to be inducible in the gut-associated lymphoid compartment and associated with immunological tolerance. The hypothesis of the study is that the induction of Treg cells will be associated with clinical tolerance. The investigators will measure the change from baseline of induced Treg cells as a frequency of total CD4 T cells during active treatment and compare that between participants who achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined below) and those who do not (Treatment Failure Group).

Eligibility Criteria

Inclusion Criteria

Diagnosis of peanut allergy by a positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) and by medical history or Serum peanut-specific IgE >5 kU/L at screening visit.
Ara h 2 specific IgE >0.35 kU/L at screening visit
Ability to provide informed consent.
Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy.
React to less than 443 mg of peanut protein during DBPCFC1

Exclusion Criteria

History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
Severe or Moderate asthma as defined using the severity criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
Poorly-controlled asthma as defined by FEV1 2 days/week or rescue medication use >2 days / week.
Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
Inability to cooperate with and/or perform oral food challenge procedures.
Primary Immune Deficiency
Allergy to oat confirmed by skin prick testing and history
Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
Hemoglobin level less than 12.5 gm/dL at screening. Weight <23 kg
Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01750879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.