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Completed

NCT Number: NCT00382148

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

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.

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Key information

Conditions

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

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

Subcutaneous repeating dose

Primary outcomes

  1. Serious Adverse Events

    Time frame: Through Week 52

    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

Secondary outcomes

  1. Food Allergen Exposure, Assessed on Patient-reported Questionnaire

    Time frame: Every 4 weeks through Week 52

    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)."

  2. Food-allergic Reactions As Assessed by the Ewan Scale

    Time frame: Through Week 52

    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"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). 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.

  3. Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs

    Time frame: Through Week 52

    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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2006
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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