Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (PRROTECT)

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Boston Children's Hospital

Status and phase

Completed
Phase 2
Phase 1

Conditions

Food Allergy
Peanut Allergy

Treatments

Drug: Omalizumab
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01781637
Peanut 002

Details and patient eligibility

About

The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Full description

36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital. Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.

Enrollment

36 patients

Sex

All

Ages

7 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
  • Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
  • ImmunoCAP IgE level to peanut > 10 kU/L.
  • Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.

Exclusion criteria

  • Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
  • Positive reaction to the placebo on DBPCFC.
  • Previous reaction to omalizumab.
  • Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

36 participants in 2 patient groups, including a placebo group

omalizumab group
Experimental group
Description:
Patients will receive omalizumab.
Treatment:
Drug: Omalizumab
placebo
Placebo Comparator group
Description:
Patients will receive placebo.
Treatment:
Drug: placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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