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Monoclonal Antibodies

Omalizumab for Peanut Allergy (PRROTECT Trial)

Phase 1 & 2
Waitlist Available
Led By Lynda C Schneider, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after last dose of omalizumab/placebo
Awards & highlights

PRROTECT Trial Summary

This trial will test if a drug can safely and quickly help people with severe peanut allergies by reducing their reactions and allowing them to be better desensitized.

Eligible Conditions
  • Peanut Allergy
  • Food Allergy

PRROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after last dose of omalizumab/placebo
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after last dose of omalizumab/placebo for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Omalizumab
Secondary outcome measures
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151
77%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omalizumab

PRROTECT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: omalizumab groupExperimental Treatment1 Intervention
Patients will receive omalizumab.
Group II: placeboPlacebo Group1 Intervention
Patients will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omalizumab
2006
Completed Phase 4
~2350

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,694 Total Patients Enrolled
Stanford UniversityOTHER
2,387 Previous Clinical Trials
17,334,114 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,267 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different hospitals is this clinical trial taking place?

"Patients are currently being accepted at 5 different locations: Division of Immunology, Children's Hospital Boston in Boston, Massachusetts; Stanford University in Stanford, California; Children's Hospital of Philadelphia in Philadelphia, Pennsylvania; and 4 other hospitals."

Answered by AI

Are they looking for more test subjects for this experiment?

"From what is available on clinicaltrials.gov, it appears as if this study is not currently looking for patients to enroll. Although, it's worth noting that the trial was first posted on 1/1/2022 and most recently updated on 1/11/2022. Additionally, there are other 297 trials which are still recruiting patients."

Answered by AI

For what conditions is Omalizumab most often prescribed?

"Omalizumab is used to treat allergic reactions to airborne allergens. It can also be used to manage symptoms of conditions like moderate asthma that are not well controlled by inhaled corticosteroids, histamine h1 antagonists, and non-sedating medications."

Answered by AI

Are there prerequisites for joining this particular research study?

"The clinical trial's requirements for participants are that they must have a peanut allergy and be between 7 to 25 years old. They aim to enroll 36 individuals in total."

Answered by AI

Could you tell me if there has been any other research done on Omalizumab?

"Omalizumab is being studied in 23 clinical trials, six of which are Phase 3. Although several Omalizumab trials are based in Jerez de la Frontera, Cádiz, there are a total of 254 clinical trial locations for this medication."

Answered by AI

How many people will be included in this experiment?

"This trial is no longer enrolling new patients; however, it was active from 1/1/2013 to 1/11/2022. If you are looking for similar studies, there are currently 23 Omalizumab trials and 274 clinical trials for peanut allergies that are actively recruiting participants."

Answered by AI

Is this experimental treatment available to patients who are of age?

"The minimum age limit for this study is 7 years old, whereas the maximum age an enrollee can be is 25."

Answered by AI
Recent research and studies
Cell Reports MedicineJournal
High-resolution Epitope Mapping by Allerscan Reveals Relationships Between Ige and Igg Repertoires During Peanut Oral Immunotherapy
Chen, Genghao, Ellen L. Shrock, Mamie Z. Li, Jonathan M. Spergel, Kari C. Nadeau, Jacqueline A. Pongracic, Dale T. Umetsu, et al.. 2021. “High-resolution Epitope Mapping by Allerscan Reveals Relationships Between Ige and Igg Repertoires During Peanut Oral Immunotherapy”. Cell Reports Medicine. Elsevier BV. doi:10.1016/j.xcrm.2021.100410.
clinicaltrials.govStudy
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Lynda Schneider 2013. "Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01781637.
~3 spots leftby Apr 2025
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