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

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ClinicalTrials.gov Identifier: NCT01781637
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Results First Posted : May 3, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Lynda Schneider, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Peanut Allergy
Food Allergy
Interventions Drug: Omalizumab
Drug: placebo
Enrollment 36

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omalizumab Group Placebo
Hide Arm/Group Description

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Patients will receive placebo.

placebo: subcutaneous injection

Period Title: Overall Study
Started 28 8
Completed 24 2
Not Completed 4 6
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             2             6
Withdrawal by Subject             1             0
Arm/Group Title Omalizumab Group Placebo Total
Hide Arm/Group Description

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Patients will receive placebo.

placebo: subcutaneous injection

Total of all reporting groups
Overall Number of Baseline Participants 29 8 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 8 participants 37 participants
10
(7 to 19)
10
(6 to 17)
10
(6 to 19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
Female
11
  37.9%
4
  50.0%
15
  40.5%
Male
18
  62.1%
4
  50.0%
22
  59.5%
Baseline population   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 8 participants 37 participants
29
 100.0%
8
 100.0%
37
 100.0%
[1]
Measure Analysis Population Description: One subject declined treatment after being randomized but before beginning treatment
1.Primary Outcome
Title Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Hide Description [Not Specified]
Time Frame 6 weeks after last dose of omalizumab/placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omalizumab Group Placebo
Hide Arm/Group Description:

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Patients will receive placebo.

placebo: subcutaneous injection

Overall Number of Participants Analyzed 29 8
Measure Type: Count of Participants
Unit of Measure: Participants
23
  79.3%
1
  12.5%
2.Secondary Outcome
Title Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Hide Description [Not Specified]
Time Frame 12 weeks after last dose of omalizumab/placebo
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omalizumab Group Placebo
Hide Arm/Group Description:

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Patients will receive placebo.

placebo: subcutaneous injection

Overall Number of Participants Analyzed 29 8
Measure Type: Count of Participants
Unit of Measure: Participants
20
  69.0%
1
  12.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omalizumab Group Placebo
Hide Arm/Group Description

Patients will receive omalizumab.

Omalizumab: subcutaneous injection

Patients will receive placebo.

placebo: subcutaneous injection

All-Cause Mortality
Omalizumab Group Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omalizumab Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/28 (14.29%)      3/8 (37.50%)    
Immune system disorders     
Anaphylaxis  3/28 (10.71%)  3 3/8 (37.50%)  3
Psychiatric disorders     
Psychiatric  1/28 (3.57%)  1 0/8 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omalizumab Group Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/28 (100.00%)      8/8 (100.00%)    
Gastrointestinal disorders     
Abdominal Pain  10/28 (35.71%)  5/8 (62.50%) 
Diarrhea  4/28 (14.29%)  0/8 (0.00%) 
Nausea  11/28 (39.29%)  2/8 (25.00%) 
Vomiting  0/28 (0.00%)  2/8 (25.00%) 
General disorders     
Fever  2/28 (7.14%)  0/8 (0.00%) 
Immune system disorders     
Anaphylaxis  2/28 (7.14%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic Rhinitis  4/28 (14.29%)  0/8 (0.00%) 
Cough  6/28 (21.43%)  0/8 (0.00%) 
Sore Throat  2/28 (7.14%)  0/8 (0.00%) 
Upper Respiratory Infection  3/28 (10.71%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  9/28 (32.14%)  0/8 (0.00%) 
Rash Maculo-Papular  3/28 (10.71%)  0/8 (0.00%) 
Urticaria  0/28 (0.00%)  2/8 (25.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lynda Schneider
Organization: Boston Children's Hospital
Phone: 617-355-6180
Responsible Party: Lynda Schneider, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01781637     History of Changes
Other Study ID Numbers: Peanut 002
First Submitted: January 30, 2013
First Posted: February 1, 2013
Results First Submitted: March 23, 2017
Results First Posted: May 3, 2017
Last Update Posted: March 20, 2018