A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)

This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.

Study Overview

• Status: Completed
• Conditions: Peanut Hypersensitivity
• Intervention / Treatment: Drug: omalizumab

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Completion of last visit (or early termination visit, if applicable) for Study Q2788g
• Signed Informed Consent Form
• Use of an effective method of contraception for females of childbearing potential
• Body weight ≥ 20 kg and ≤ 150 kg
• IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)

Exclusion Criteria:

• Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
• Current participation in another investigational study
• Pregnancy or lactation
• History of brittle asthma
• Aspirin-sensitive asthma
• Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
• Have a polymorrphonuclear count <1500/uL
• Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
• Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
• Thrombocytopenia as evidenced by a platelet count < 100,000/uL
• Any systemic condition requiring regular administration of an immunoglobulin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: omalizumab; SC repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator	Through Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Allergen Exposure, Assessed on Patient-reported Questionnaire	Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."	Every 4 weeks through Week 52
Food-allergic Reactions As Assessed by the Ewan Scale	The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator	Through Week 52
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs	All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.	Through Week 52

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Dennis Wong, M.D., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: September 26, 2006
• First Submitted That Met QC Criteria: September 26, 2006
• First Posted (Estimate): September 28, 2006

Study Record Updates

• Last Update Posted (Estimate): December 15, 2009
• Last Update Submitted That Met QC Criteria: November 12, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Allergy; Peanut allergy; TOPS; Peanut-induced allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: Q3623g