The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

NCT01003301 | Completed Phase 2 Results DMC

• 2 other identifiers: NA_00027984U19AI070345
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells. Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.

Conditions

Cat Allergy

Keywords

cat allergy

Outcome Measures

Primary Outcomes (1)

• The the Size of the 8 Late-phase Skin Response

  Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.

  Baseline, 2-6 wks

Study Arms (2)

Omalizumab

EXPERIMENTAL

Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.

Drug: Placebo

Interventions

Omalizumab DRUG

Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Also known as: Xolair, Anti-IgE

Omalizumab

Placebo DRUG

Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, ages 18-50
• Females must be surgically sterile or postmenopausal or using a specified acceptable form of birth control throughout the duration of the study. Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.
• Females must have a negative urine pregnancy test at Visit A and other visits specified in this protocol.
• Clinical history of perennial allergic rhinitis for at least two years, with or without seasonal allergic rhinitis, and with or without mild persistent asthma as define by the 2007 NAEPP guidelines.
• Allergic cat sensitization defined by a positive puncture skin test (mean wheal diameter 3 mm or more greater than diluent control), and a positive CAP-RAST to cat \> 0.35 kU/L.
• Positive intranasal cat allergen challenge defined by the induction of a total of ≥ 5 sneezes at screening(criterion not applicable in the ancillary study).
• Baseline in vitro histamine release of peripheral blood basophils to cat allergen ≥7%.
• Peripheral blood basophils \> two million per 100 ml of blood (criterion only applicable in the ancillary study)

You may not qualify if:

• Asthma with baseline FEV1 \< 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
• Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
• Individuals with reduced hematocrit (\< 32%), WBC count (2400/microliter), platelet count (\< 75000/microliter), and increased creatinine (\> 141.4 micromolar/L), or AST (\> 100 IU/L).
• Individuals with body weight less than 30 kg or greater than 150 kg.
• Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
• Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
• History of malignancy, anaphylaxis or bleeding disorder.
• Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
• Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• Use of any investigational drugs within 8 weeks of participation.
• Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
• Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
• Any prior use of omalizumab.
• Frequent episodes of acute sinusitis (\>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
• Use of aeroallergen immunotherapy within 5 years prior to enrollment

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

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MeSH Terms

Interventions

Omalizumab; anti-IgE antibodies

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarbjit S. Saini
• Organization: Johns Hopkins University

ssaini@jhmi.edu

410-550-2129

Study Officials

• Sarbjit Saini, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2013
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

US (1)