The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

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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Key information

Conditions

Healthy Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
(Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
Physical examination findings within normal limits
Body mass index (BMI) between 18 and 30, inclusive

Exclusion criteria

Pregnancy and lactation
Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
History of drug abuse
Participation in an investigational drug or device trial within the last 30 days prior to screening

Treatment and study plan

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.

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.

Primary outcomes

Number of Participants by of Adverse Events Following a Skin Test Procedure

Time frame: Up to 7 days following skin testing

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.
Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)

Time frame: on the day of skin 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.
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)

Time frame: on the day of skin test

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.
Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)

Time frame: on the day of skin test

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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 22, 2008
Registry last updated: Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed