Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (PRROTECT)
This study is currently recruiting participants.
Verified April 2013 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Collaborators:
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Dale T Umetsu, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01781637
First received: January 30, 2013
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
| Condition | Intervention | Phase |
|---|---|---|
|
Peanut Allergy Food Allergy |
Drug: Omalizumab Drug: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Omalizumab in Oral Peanut Desensitization |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- The ability of omalizumab-treated subjects to successfully complete the build-up phase of peanut, and tolerate daily 4,000 mg doses of peanut flour after discontinuing omalizumab. [ Time Frame: 14 wks after the start of oral peanut desensitization (wk 26 of study). ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The ability of subjects to tolerate an oral dose of 4,000 mg peanut. [ Time Frame: 8 wks after the start of oral peanut desensitization (study wk 20). ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: omalizumab group
Patients will receive omalizumab.
|
Drug: Omalizumab
subcutaneous injection
Other Name: Xolair
|
|
Placebo Comparator: placebo
Patients will receive placebo.
|
Drug: placebo
subcutaneous injection
|
Detailed Description:
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.
Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
Eligibility| Ages Eligible for Study: | 7 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
- Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
- ImmunoCAP IgE level to peanut > 10 kU/L.
- Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Exclusion Criteria:
- Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.
- Positive reaction to the placebo on DBPCFC.
- Previous reaction to omalizumab.
- Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781637
Contacts
| Contact: Tim Harrington | 617-355-6127 | timothy.harrington@childrens.harvard.edu |
| Contact: Dale T Umetsu, MD, PhD | 617 919 2439 |
Locations
| United States, California | |
| Stanford University | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Sue Neale-May, RN 650-723-5227 suenealemay@stanford.edu | |
| Principal Investigator: Kari C Nadeau, MD, PhD | |
| United States, Illinois | |
| Lurie Children's Hospital | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Maripaz Vazquez, BSN 312-227-6474 MVAZQUEZ@LURIECHILDRENS.ORG | |
| Principal Investigator: Jacqueline Pongracic, MD | |
| United States, Massachusetts | |
| Division of Immunology, Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Tim Harrington 617-355-4349 timothy.harrington@childrens.harvard.edu | |
| Contact: Jessica Skalinski 617-919 2439 SkalinskiJessica.Skalinski@childrens.harvard.edu | |
| Principal Investigator: Dale T Umetsu, MD, PhD | |
| Sub-Investigator: Lynda Schneider, MD | |
| Sub-Investigator: Rima Rachid, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Courtney B Rooney 267-426-8657 ROONEYC@EMAIL.CHOP.EDU | |
| Principal Investigator: Jonathan Spergel, MD, PhD | |
Sponsors and Collaborators
Children's Hospital Boston
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
| Principal Investigator: | Dale T Umetsu, MD, PhD | Children's Hospital Boston |
| Study Chair: | Lynda Schneider, MD | Children' Hospital Boston |
| Study Chair: | Kari Nadeau, MD, PhD | Stanford University |
| Study Chair: | Jonathan Spergel, MD, PhD | Children's Hospital of Philadelphia |
| Study Chair: | Jacqueline Pongracic, MD | Lurie Children's Hospital |
More Information
No publications provided
| Responsible Party: | Dale T Umetsu, Professor, Harvard Medical School, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01781637 History of Changes |
| Other Study ID Numbers: | Peanut 002 |
| Study First Received: | January 30, 2013 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Boston:
|
Xolair omalizumab peanut oral desensitization |
Additional relevant MeSH terms:
|
Food Hypersensitivity Hypersensitivity Peanut Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Omalizumab |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013