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

NCT00382148 | Completed Phase 2 Results

• 1 other identifier: Q3623g
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peanut Hypersensitivity

Keywords

TOPS; Peanut allergy; Peanut-induced allergy; Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Food Allergen Exposure, Assessed on Patient-reported Questionnaire

  Every 4 weeks through Week 52

• Food-allergic Reactions As Assessed by the Ewan Scale

  Through Week 52

• Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs

  Through Week 52

Study Arms (1)

1

EXPERIMENTAL

Drug: omalizumab

Interventions

omalizumab DRUG

SC repeating dose

1

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

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: Medical Communications Specialist
• 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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Last Updated: December 15, 2009
• Results First Posted: December 15, 2009

Record last verified: 2009-11