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

Genentech

Status and phase: Completed; Phase 4

Conditions: Asthma; Healthy

Treatments: Drug: Cohort I; Drug: Cohort 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777764

Q4465g

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Drug: Cohort I

Allergic Asthma Participants

Experimental group

Description:

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.

Treatment:

Drug: Cohort 2