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This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. |
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| Allergic Asthma Participants | Experimental | Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort I | Drug | In sterile water for injection (SWFI), full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:1000, 1:100 and 1:10 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially with positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were in SWFI. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by of Adverse Events Following a Skin Test Procedure | Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death. | Up to 7 days following skin testing |
| Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test) | For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. | on the day of skin test |
| Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers) | For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. | on the day of skin test |
| Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma) | For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Wong, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subjects | Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI). |
| FG001 | Allergic Asthma Participants | Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in saline solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subjects | Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants by of Adverse Events Following a Skin Test Procedure | Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours. Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death. | Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. | Posted | Number | participants | Up to 7 days following skin testing |
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Safety-evaluable population.
Note: The incidence of each AE is reported as the number of participants experiencing the event, not the number of occurrences for each AE. AEs are reported regardless of the investigator's assessment of relation to study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Subjects | Healthy participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and 1:1000, 1:100, 1:10 dilution and full concentrations of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:1000, 1:100 and 1:10 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in sterile water for injection (SWFI). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C423142 | KPNA1 protein, human |
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| Cohort 2 | Drug | In a saline solution, full concentration and 1:1000, 1:100, 1:10 dilutions of 125 mg/mL of standard solution of omalizumab and its excipients. Skin prick test of each dilution concentration of 1:1000, 1:100, 1:10 and full concentration and Intradermal tests of each dilution concentration of 1:100,000 and 1:10,000 were followed by 20 minutes of observation. For the skin prick test, participants were tested initially by positive control (histamine 6 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. For the intradermal test, participants were tested initially with positive control (histamine 0.1 mg/mL) and negative control (saline), and with omalizumab and its excipients simultaneously from the lowest concentration. Dilutions of omalizumab and its excipients were made in saline. |
|
| on the day of skin test |
| BG001 | Allergic Asthma Participants | Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in saline solution. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Allergic Asthma Participants | Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in saline solution. |
|
|
| Primary | Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test) | For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. | Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.) | Posted | Number | participants | on the day of skin test |
|
|
|
| Primary | Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers) | For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. | Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.) | Posted | Number | participants | on the day of skin test |
|
|
|
| Primary | Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma) | For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. | Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.) | Posted | Number | participants | on the day of skin test |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Allergic Asthma Participants | Allergic asthma participants were tested sequentially in a skin prick test procedure with positive control (histamine 6 mg/mL), negative control (saline), and a succession of 1:1000, 1:100, 1:10 dilutions and full concentration of both omalizumab and omalizumab excipients. Without reaction, this then followed a sequential intradermal test procedure with positive control (histamine 0.1 mg/mL), negative control (saline), and 1:100,000 and 1:10,000 dilution concentrations of omalizumab and its excipients. There was a 20 minute observation period following all dosings. Excipients include sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20. Dilutions of omalizumab and its excipients were made in saline solution. | 0 | 30 | 3 | 30 |
| Sinusitis | Infections and infestations |
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| Headache | Nervous system disorders |
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| Syncope | Nervous system disorders |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| 1:100 Dilution; Excipient |
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| 1:100 Dilution; Omalizumab |
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| 1:10 Dilution; Excipient |
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| 1:10 Dilution; Omalizumab |
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| Undiluted; Excipient |
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| Undiluted; Omalizumab |
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| Title | Measurements |
|---|---|
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| 1:100 Dilution; Omalizumab |
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| 1:10 Dilution; Excipient |
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| 1:10 Dilution; Omalizumab |
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| Title | Measurements |
|---|---|
|
| 1:10,000 Dilution; Omalizumab |
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