Trial Outcomes & Findings for Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils (NCT NCT02023151)

NCT ID: NCT02023151

Last Updated: 2017-12-11

Results Overview

Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: baseline and 26 weeks
• Results posted on: 2017-12-11

Participant Flow

Participant milestones

Measure	Omalizumab Active Omalizumab
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Omalizumab Active Omalizumab
Overall Study Lost to Follow-up	4

Baseline Characteristics

Predicting the Clinical Response to Omalizumab With Anti-Immunoglobulin E (IgE) Ab Response or Syk Expression in Basophils

Baseline characteristics by cohort

Measure	Omalizumab n=13 Participants Active Omalizumab
Age, Continuous	41 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 26 weeks

Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response

Outcome measures

Measure	Omalizumab n=13 Participants Active Omalizumab
Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab	7.8 Fold change in basophil Syk expression Standard Deviation 4.8

SECONDARY outcome

Timeframe: baseline and 26 weeks

Change in syk expression. Syk is a signaling molecule that is the first downstream event in IgE receptor activation of basophils.

Outcome measures

Measure	Omalizumab n=13 Participants Active Omalizumab
Changes in Syk Expression	2.3 fold change Standard Deviation .4

Adverse Events

Omalizumab

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Omalizumab n=13 participants at risk Active Omalizumab
Infections and infestations Infections	76.9% 10/13 • Number of events 12 • 26 weeks

Additional Information

Sarbjit Saini

Johns Hopkins University

Phone: 4105502191

Email: ssaini@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place