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Omalizumab in the Treatment of Peanut Allergy

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ClinicalTrials.gov Identifier: NCT00949078
Recruitment Status : Completed
First Posted : July 30, 2009
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Food Allergy
Peanut Allergy
Intervention: Drug: omalizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
51 participants underwent screening history and laboratory evaluation. Of those, 14 underwent a screening food challenge and were randomized to subsequent arms.

Reporting Groups
  Description
Open Label Omalizumab Group A

Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.

omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Open Label Omalizumab Group B

Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.

omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE

Participant Flow:   Overall Study
    Open Label Omalizumab Group A   Open Label Omalizumab Group B
STARTED   5   9 
COMPLETED   5   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Label Omalizumab Group A

Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.

omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Open Label Omalizumab Group B

Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.

omalizumab: omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Total Total of all reporting groups

Baseline Measures
   Open Label Omalizumab Group A   Open Label Omalizumab Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 5   9   14 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      9 100.0%      14 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      4  80.0%      7  77.8%      11  78.6% 
Male      1  20.0%      2  22.2%      3  21.4% 
Region of Enrollment 
[Units: Participants]
 		     
United States   5   9   14 


  Outcome Measures

1.  Primary:   Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8   [ Time Frame: up to 6 months ]
  Show Outcome Measure 1

2.  Primary:   Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response   [ Time Frame: change from baseline to up to 6 months ]
  Show Outcome Measure 2

3.  Primary:   Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response   [ Time Frame: up to 6 months ]
  Show Outcome Measure 3

4.  Primary:   Total Immunoglobulin E (IgE) After Pn-BHR Response   [ Time Frame: up to 6 months ]
  Show Outcome Measure 4

5.  Primary:   Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 5

6.  Primary:   Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 6

7.  Primary:   Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 7

8.  Primary:   Omalizumab Received Before OFC 2   [ Time Frame: up to 6 months ]
  Show Outcome Measure 8

9.  Primary:   Omalizumab Received Before OFC 2   [ Time Frame: up to 6 months ]
  Show Outcome Measure 9


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Robert Wood, M.D.
Organization: Johns Hopkins University School of Medicine
phone: rwood@jhmi.edu
e-mail: rwood@jhmi.edu


Publications:


Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00949078     History of Changes
Other Study ID Numbers: NA_00026397
1U19AI070345 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2009
First Posted: July 30, 2009
Results First Submitted: February 22, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017