Treatment for Food Allergy

Phase-Based Progress Estimates
Icahn School of Medicine at Mount Sinai, New York, NYFood Allergy+1 MorePeanut Protein - Biological
4 - 14
All Sexes
What conditions do you have?

Study Summary

This trial is testing whether kids with a high threshold for peanut allergies can eat small amounts of peanuts to build up a tolerance, and if this changes their quality of life.

Eligible Conditions
  • Food Allergy
  • Peanut Allergy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: up to 96 weeks

baseline and 72 weeks
Immunoglobulin E
Change in Peanut-specific IgG4
Change in SPT wheal size
up to 72 weeks
Food Allergy Quality of Life Parental Burden Instrument
The difference in the percentage of children that tolerate the full challenge
up to 96 weeks
Number of acute allergic reactions
The percentage of children that achieve sustained unresponsiveness

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Active Control

73 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · No Placebo Group · Phase 2

AvoidanceNoIntervention Group · 1 Intervention: Avoidance · Intervention Types:
ActiveComparator Group · 1 Intervention: Peanut Protein · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 96 weeks

Who is running the clinical trial?

Scott SichererLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,172 Previous Clinical Trials
4,939,863 Total Patients Enrolled
11 Trials studying Food Allergy
12,185 Patients Enrolled for Food Allergy
Scott Sicherer, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Medical School - Johns Hopkins University, Doctor of Medicine
The Mount Sinai Hospital, Residency in Pediatrics
7 Previous Clinical Trials
804 Total Patients Enrolled
2 Trials studying Food Allergy
100 Patients Enrolled for Food Allergy

Eligibility Criteria

Age 4 - 14 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Will geriatric participants be included in this investigation?

"As indicated by the inclusionary criteria, this trial is open to those between 4 and 14 years old. Additionally, there are 88 studies for minors under 18 and 158 study opportunities available for people above 65." - Anonymous Online Contributor

Unverified Answer

Has the recruitment phase for this trial commenced?

"Affirmative.'s records demonstrate that this medical experiment, initially posted on August 5th 2019, is enrolling patients. 74 participants must be recruited from 1 of the available sites." - Anonymous Online Contributor

Unverified Answer

To whom is participation in this clinical trial being offered?

"This study is seeking 74 children aged 4 to 14 with a confirmed peanut allergy. To be eligible, the patient (or their guardian) must provide informed consent and have IgE levels of 0.35 kUA/L or higher after avoiding peanuts for at least three days before screening. Furthermore, patients should be able to consume between 143 mg and 5043 mg of peanut protein during oral food challenge testing on the day of screening. Informed consent from both parent(s)/guardian(s) and child are necessary in order to participate in this trial." - Anonymous Online Contributor

Unverified Answer

Does this medication have governmental sanctioning?

"Adequate prior evidence confirms that this therapeutic intervention is safe, and thus it has been awarded a score of 2 on the Power scale. However, since this is still a Phase 2 trial, data supporting efficacy remains absent." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants in this experiment?

"That is correct. shows that the trial, initially posted on August 5th 2019, is still seeking participants with 74 patients to be recruited from 1 location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.