A Safety and Efficacy Study of Xolair in Peanut Allergy

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Xolair (omalizumab)

About this trial

This is an interventional treatment trial for Allergy focused on measuring Peanut

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient has a diagnosis of acute peanut allergy The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms The patient is six to 75 years of age The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC) The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level The patient is able to swallow capsules Exclusion Criteria: Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions Have a history of allergy to wheat protein Have previously been exposed to monoclonal antibody treatment

Sites / Locations

Trial Information Support Line

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00086606

First Posted

July 6, 2004

Last Updated

January 17, 2013

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00086606

Brief Title

A Safety and Efficacy Study of Xolair in Peanut Allergy

Official Title

A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Terminated

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary

This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

Keywords

Peanut

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Xolair (omalizumab)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: The patient has a diagnosis of acute peanut allergy The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms The patient is six to 75 years of age The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC) The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level The patient is able to swallow capsules Exclusion Criteria: Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions Have a history of allergy to wheat protein Have previously been exposed to monoclonal antibody treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yamo Deniz, M.D.

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Trial Information Support Line

City

Denver

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Allergy

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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