Trial Outcomes & Findings for Effect of Omalizumab (Xolair) on Basophils in Patients With Chronic Idiopathic Urticaria (NCT NCT01701583)

Last Updated: 2020-12-04

Results Overview

In patients with chronic urticaria who respond clinically to omalizumab, the proteome of blood basophils will be measured at baseline (pre-treatment) and at weeks 6 and 13 (post-treatment). The number of participants with a change observed in basophil proteome out of the total number of participants, stratified by responders and non-responders, is reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Baseline through week 13

Results posted on

2020-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Omalizumab Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks	Controls Control subjects without urticaria who did not receive omalizumab
Overall Study STARTED	7	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Omalizumab Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks	Controls Control subjects without urticaria who did not receive omalizumab
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Only the 7 subjects with urticaria completed UAS7 scores. The 3 controls did not have urticaria.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab n=7 Participants Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.	Controls n=3 Participants Control subjects without urticaria who did not receive omalizumab	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	3 Participants n=3 Participants	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	7 Participants n=7 Participants	2 Participants n=3 Participants	9 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=7 Participants	1 Participants n=3 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	6 Participants n=7 Participants	3 Participants n=3 Participants	9 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=10 Participants
Urticaria Activity Score for 7 days	30 units on a scale STANDARD_DEVIATION 11 • n=7 Participants • Only the 7 subjects with urticaria completed UAS7 scores. The 3 controls did not have urticaria.	—	30 units on a scale STANDARD_DEVIATION 11 • n=7 Participants • Only the 7 subjects with urticaria completed UAS7 scores. The 3 controls did not have urticaria.

PRIMARY outcome

Timeframe: Baseline through week 13

Population: There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. There was insufficient data for weeks 6 and 13 to analyze primary outcome.

Outcome measures

Outcome measures
Measure	Omalizumab Responders n=4 Participants Subjects with chronic urticaria, treated with omalizumab who responded to the drug	Controls n=3 Participants Subjects without chronic urticaria, not treated with omalizumab	Omalizumab Non-responders n=3 Participants Subjects with chronic urticaria, treated with omalizumab who did not respond to the drug
Change in the Basophil Proteome Baseline	4 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline through week 13

Population: There were 7 subjects with chronic urticaria treated with omalizumab and 3 control subjects without chronic urticaria, not treated with omalizumab. Because the data from subsequent time points was not able to be analyzed, the investigators were unable to analyze this outcome because no change comparison could be made.

Change in basophil proteome in responders to omalizumab compared to non-responders to omalizumab. However, there was insufficient data from weeks 6 and 13 to analyze this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Omalizumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omalizumab n=7 participants at risk Omalizumab 300mg subcutaneously every 4 weeks for 12 weeks	Controls n=3 participants at risk Control subjects without urticaria who did not receive omalizumab
Nervous system disorders Headache	42.9% 3/7 • Number of events 3 • Baseline to week 13	0.00% 0/3 • Baseline to week 13
Endocrine disorders Flushing	14.3% 1/7 • Number of events 1 • Baseline to week 13	0.00% 0/3 • Baseline to week 13

Additional Information

Jenny Stitt

University of Colorado

Phone: 303-724-7205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place