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

NCT00777764 | Completed Phase 4 Results

• 1 other identifier: Q4465g
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy; Asthma

Keywords

Xolair; Asthma; Skin Tests

Outcome Measures

Primary Outcomes (4)

• 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.

  on the day of skin test

Study Arms (2)

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.

Drug: Cohort I

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.

Drug: Cohort 2

Interventions

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.

Healthy Volunteers

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.

Allergic Asthma Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Asthma

Interventions

KPNA1 protein, human

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Dennis Wong, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: August 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 14, 2017
• Results First Posted: February 14, 2011

Record last verified: 2017-05