Trial Outcomes & Findings for Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma) (NCT NCT00367016)

Results Overview

Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

3 months

Results posted on

2021-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Omalizumab Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens	Placebo Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens
Overall Study STARTED	3	3
Overall Study First Intervention	3	3
Overall Study Second Intervention	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab n=3 Participants Subjects will receive subcutaneous Omalizumab for 6 months. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens	Placebo n=3 Participants Subjects will receive subcutaneous placebo for 6 months. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Skin biopsy was not collected from one of the subjects randomized to placebo.

Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification.

Outcome measures

Outcome measures
Measure	Omalizumab n=3 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.	Placebo n=2 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.
FcεRI (High Affinity Receptor) Levels at 3 Months	20.5 Positive cells per field Interval 3.0 to 38.0	13.66 Positive cells per field Interval 8.0 to 28.0

PRIMARY outcome

Timeframe: 6 months

Skin biopsies were collected from patients after 0 (pre), 3 (pos1) and 6 (pos2) months of omalizumab (P11, P36, P42) or placebo (P7 and P38) treatment. The skin was fixed and the paraffin-embedded sections were stained for high affinity receptors. The average numbers of positively stained cells in each field were counted under a microscope at 400X magnification.

Outcome measures

Outcome measures
Measure	Omalizumab n=3 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.	Placebo n=2 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.
FcεRI (High Affinity Receptor) Levels at 6 Months	17 Positive cells per field Interval 5.0 to 38.0	22.5 Positive cells per field Interval 15.0 to 30.0

SECONDARY outcome

Timeframe: 6 months

Total sera IgE levels are increased upon anti-IgE treatment. Sera from each patient were collected every month after omalizumab (P11, P36 and P42) or placebo (P7, P37 and P38) treatment. The sera IgE levels were measured by ELISA using polyclonal goat anti-human IgE as the capture antibody and HRP-goat anti-human IgE as the detection antibody.

Outcome measures

Outcome measures
Measure	Omalizumab n=3 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to Omalizumab administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.	Placebo n=3 Participants The subjects will be randomized to a treatment group and a placebo group. Prior to placebo administration, all subjects will undergo screening studies, including spirometry, blood test and skin test. Blood test includes comprehensive metabolic panel, CBC, and total and free IgE levels. Skin test will be done with a panel of 7 common allergens.
Total Sera IgE Levels at 6 Months	300 U/ml Interval 0.0 to 600.0	883.33 U/ml Interval 300.0 to 1200.0

Adverse Events

Omalizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fu-Tong Liu, M.D., Ph.D.

University of California-Davis, Department of Dermatology

Phone: 916-734-6556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place