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The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

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ClinicalTrials.gov Identifier: NCT01003301
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
Information provided by (Responsible Party):
Sarbjit Saini, Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Cat Allergy
Interventions Drug: Omalizumab
Drug: Placebo
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description

Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Period Title: Overall Study
Started 10 9
Completed 10 9
Not Completed 0 0
Arm/Group Title Omalizumab Placebo Total
Hide Arm/Group Description

Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Total of all reporting groups
Overall Number of Baseline Participants 10 9 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 19 participants
23.7
(19 to 30)
25.1
(18 to 35)
24
(18 to 35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 19 participants
Female
7
  70.0%
6
  66.7%
13
  68.4%
Male
3
  30.0%
3
  33.3%
6
  31.6%
1.Primary Outcome
Title The the Size of the 8 Late-phase Skin Response
Hide Description Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.
Time Frame Baseline, 2-6 wks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description:

Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Overall Number of Participants Analyzed 10 9
Mean (Standard Deviation)
Unit of Measure: percentage decline from NAC-1
54  (4) 0  (5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omalizumab Placebo
Hide Arm/Group Description

Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

All-Cause Mortality
Omalizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Omalizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omalizumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/9 (0.00%) 
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: Sarbjit S. Saini
Organization: Johns Hopkins University
Phone: 410-550-2129
Publications:
Group IEW. Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, April 1996.
Responsible Party: Sarbjit Saini, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01003301     History of Changes
Other Study ID Numbers: NA_00027984
U19AI070345 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2009
First Posted: October 28, 2009
Results First Submitted: January 7, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014