Trial Outcomes & Findings for The Effect of Omalizumab on Responses to Cat Allergen Challenge (NCT NCT00604786)

NCT ID: NCT00604786

Last Updated: 2017-05-10

Results Overview

Flow cytometry in mean fluorescence units. 100%\*\[(3.5 month value minus baseline value)/baseline value\]

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Change from baseline to 3.5 months
• Results posted on: 2017-05-10

Participant Flow

Participant milestones

Measure	Omalizumab Subcutaneous This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks	Placebo Subcutaneous This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.
Overall Study STARTED	14	4
Overall Study COMPLETED	12	4
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Omalizumab Subcutaneous This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and immunoglobulin E (IgE) based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks	Placebo Subcutaneous This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

The Effect of Omalizumab on Responses to Cat Allergen Challenge

Baseline characteristics by cohort

Measure	Active Treatment n=14 Participants This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma. omalizumab: IgE 30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks \>90-150 kg: 300 mg every 4 weeks IgE \>100-200 int. units/mL: 30-90 kg: 300 mg every 4 weeks \>90-150 kg: 225 mg every 2 weeks IgE \>200-300 int. units/mL: 30-60 kg: 300 mg every 4 weeks \>60-90 kg: 225 mg every 2 weeks \>90-150 kg: 300 mg every 2 weeks IgE \>300-400 int. units/mL: 30-70 kg: 225 mg every 2 weeks \>70-90 kg: 300 mg every 2 weeks \>90 kg: Do not administer dose IgE \>400-500 int. units/mL: 30-70 kg: 300 mg every 2 weeks \>70-90 kg: 375 mg every 2 weeks \>90 kg: Do not administer dose IgE \>500-600 int. units/mL: 30-60 kg: 300 mg every 2 weeks \>60-70 kg: 375 mg every 2 weeks \>70 kg: Do not administer dose IgE \>600-700 int. units/mL: 30-60 kg: 375 mg every 2 weeks \>60 kg: Do not administer dose	Placebo n=4 Participants placebo: IgE 30-100 int. units/mL: 30-90 kg: placebo every 4 weeks \>90-150 kg: placebo every 4 weeks IgE \>100-200 int. units/mL: 30-90 kg: placebo every 4 weeks \>90-150 kg: placebo every 2 weeks IgE \>200-300 int. units/mL: 30-60 kg: placebo every 4 weeks \>60-90 kg: placebo every 2 weeks \>90-150 kg: placebo every 2 weeks IgE \>300-400 int. units/mL: 30-70 kg: placebo every 2 weeks \>70-90 kg: placebo every 2 weeks \>90 kg: Do not administer dose IgE \>400-500 int. units/mL: 30-70 kg: placebo every 2 weeks \>70-90 kg: placebo every 2 weeks \>90 kg: Do not administer dose IgE \>500-600 int. units/mL: 30-60 kg: placebo every 2 weeks \>60-70 kg: placebo every 2 weeks \>70 kg: Do not administer dose IgE \>600-700 int. units/mL: 30-60 kg: placebo every 2 weeks \>60 kg: Do not administer dose	Total n=18 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	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.6 years n=5 Participants	32.3 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	4 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 3.5 months

Population: 2 participants on the Omalizumab subcutaneous group moved and were therefore lost to follow-up.

Flow cytometry in mean fluorescence units.

100%*[(3.5 month value minus baseline value)/baseline value]

Outcome measures

Measure	Omalizumab Subcutaneous n=12 Participants This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks	Placebo Subcutaneous n=4 Participants This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.
Change in Basophil Surface IgE	-95 percentage of basophil surface IgE Standard Deviation 3	-10 percentage of basophil surface IgE Standard Deviation 4

Adverse Events

Placebo Subcutaneous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omalizumab Subcutaneous

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Subcutaneous n=4 participants at risk This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks.	Omalizumab Subcutaneous n=14 participants at risk This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks
Skin and subcutaneous tissue disorders Injection site swelling	0.00% 0/4 • 3.5 months	14.3% 2/14 • 3.5 months

Additional Information

Sarbjit S. Saini

Johns Hopkins University

Phone: 410-550-2129

Email: ssaini@jhmi.edu

Results disclosure agreements

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