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

Peanut Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382148
• Other study ID #: Q3623g
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: November 12, 2009
• Start date: November 2006

Study information

• Verified date: November 2009
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Drug:
• omalizumab
SC repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious Adverse Events		Through Week 52	Yes
Secondary	Food Allergen Exposure, Assessed on Patient-reported Questionnaire		Every 4 weeks through Week 52	No
Secondary	Food-allergic Reactions As Assessed by the Ewan Scale		Through Week 52	No
Secondary	Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs		Through Week 52	No