Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Duke University Genentech |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00932282 |
The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.
Condition | Intervention | Phase |
---|---|---|
Peanut Hypersensitivity |
Drug: Peanut Oral Immunotherapy Drug: Omalizumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Peanut Oral Immunotherapy and Anti-IgE for Peanut Allergy |
Estimated Enrollment: | 10 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2014 |
Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
12 month maintenance: Active Comparator
Those subjects randomized to stay on maintenance therapy for 12 months.
|
Drug: Peanut Oral Immunotherapy
Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.
Drug: Omalizumab
Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.
|
24 month maintenance: Active Comparator
Those subjects randomized to stay on maintenance therapy for 24 months.
|
Drug: Peanut Oral Immunotherapy
Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.
Drug: Omalizumab
Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.
|
The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study if peanut oral immunotherapy (OIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance. This study will augment other ongoing studies by looking at whether anti-IgE therapy can reduce side effects and allow for an accelerated build up phase. Peanut allergic patients greater than 12 years old will undergo omalizumab (anti-IgE) treatment for 4 months prior to peanut OIT, and they will continue omalizumab until one month after maintenance therapy. Each subject will have an initial desensitization phase over 2 days to a goal of 950 mg of peanut powder followed by a build up phase over 4 months to goal maintenance dose of 8000 mg peanut powder. They will be randomized to continue maintenance for 12 or 24 months. They will then have an oral food challenge immediately after stopping peanut OIT to test for desensitization. Four weeks later, off OIT, another food challenge will be done to assess tolerance. Outcome variables of interest include results of the DBPCFCs, pre and post skin tests, CAP-FEIA values and basophil studies. These results will be compared between the starting point and the patient at the end of the study using appropriate statistical analysis.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ananth Thyagarajan, MD | 919-668-1338 | ananth.thyagarajan@duke.edu |
Contact: Pamela Steele, NP | 919-668-1333 |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Wesley Burks, MD | Duke Univesity Medical Center |
Responsible Party: | Duke University Health Systems ( A. Wesley Burks/Professor of Pediatrics ) |
Study ID Numbers: | 00015541 |
Study First Received: | June 10, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00932282 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Peanut Allergy Hypersensitivity |
Antibodies Food Hypersensitivity Hypersensitivity Peanut Hypersensitivity Hypersensitivity, Immediate |
Anti-Asthmatic Agents Anti-Allergic Agents Immunoglobulins Omalizumab |
Respiratory System Agents Food Hypersensitivity Hypersensitivity Immune System Diseases Therapeutic Uses Peanut Hypersensitivity |
Hypersensitivity, Immediate Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Omalizumab |