PRROTECT: Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01781637
• Collaborator: Children's Hospital of Philadelphia (Other), Stanford University (Other), Ann & Robert H Lurie Children's Hospital of Chicago (Other)
• Enrollment: 36
• Locations: 4
• Arms: 2
• Duration (Months): 153
• Patients Per Site: 9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Peanut Allergy; Food Allergy	Drug: Omalizumab; Drug: placebo	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of Omalizumab in Oral Peanut Desensitization
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: omalizumab group Patients will receive omalizumab.	Drug: Omalizumab; subcutaneous injection; Other Names: Xolair
Placebo Comparator: placebo Patients will receive placebo.	Drug: placebo; subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo [6 weeks after last dose of omalizumab/placebo]

Secondary Outcome Measures

1. Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo [12 weeks after last dose of omalizumab/placebo]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305
2	Lurie Children's Hospital	Chicago	Illinois	United States	60611
3	Division of Immunology, Children's Hospital Boston	Boston	Massachusetts	United States	02115
4	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Boston Children's Hospital
• Children's Hospital of Philadelphia
• Stanford University
• Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

• Principal Investigator: Lynda C Schneider, MD, Boston Children's Hospital
• Study Chair: Andrew MacGinnitie, MD, PhD, 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lynda Schneider, Professor, Harvard Medical School, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01781637
• Other Study ID Numbers: Peanut 002
• First Posted: Feb 1, 2013
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Lynda Schneider, Professor, Harvard Medical School, Boston Children's Hospital: Xolair; omalizumab; peanut; oral desensitization
• Additional relevant MeSH terms: Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Omalizumab

Study Results

Participant Flow

Arm/Group Title	Omalizumab Group	Placebo
Arm/Group Description	Patients will receive omalizumab. Omalizumab: subcutaneous injection	Patients will receive placebo. placebo: subcutaneous injection
Period Title: Overall Study
STARTED	28	8
COMPLETED	24	2
NOT COMPLETED	4	6

Baseline Characteristics

Arm/Group Title	Omalizumab Group	Placebo	Total
Arm/Group Description	Patients will receive omalizumab. Omalizumab: subcutaneous injection	Patients will receive placebo. placebo: subcutaneous injection	Total of all reporting groups
Overall Participants	29	8	37
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	10	10	10
Sex: Female, Male (Count of Participants)
Female	11 37.9%	4 50%	15 40.5%
Male	18 62.1%	4 50%	22 59.5%
Baseline population (Count of Participants)
Count of Participants [Participants]	29 100%	8 100%	37 100%

Outcome Measures

1. Primary Outcome

Title	Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Time Frame	6 weeks after last dose of omalizumab/placebo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omalizumab Group	Placebo
Arm/Group Description	Patients will receive omalizumab. Omalizumab: subcutaneous injection	Patients will receive placebo. placebo: subcutaneous injection
Measure Participants	29	8
Count of Participants [Participants]	23 79.3%	1 12.5%

2. Secondary Outcome

Title	Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Time Frame	12 weeks after last dose of omalizumab/placebo

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omalizumab Group	Placebo
Arm/Group Description	Patients will receive omalizumab. Omalizumab: subcutaneous injection	Patients will receive placebo. placebo: subcutaneous injection
Measure Participants	29	8
Count of Participants [Participants]	20 69%	1 12.5%

Adverse Events

Arm/Group Title	Omalizumab Group		Placebo
Arm/Group Description	Patients will receive omalizumab. Omalizumab: subcutaneous injection		Patients will receive placebo. placebo: subcutaneous injection
All Cause Mortality
	Omalizumab Group		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omalizumab Group		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/28 (14.3%)		3/8 (37.5%)
Immune system disorders
Anaphylaxis	3/28 (10.7%)	3	3/8 (37.5%)	3
Psychiatric disorders
Psychiatric	1/28 (3.6%)	1	0/8 (0%)	0
Other (Not Including Serious) Adverse Events
	Omalizumab Group		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/28 (100%)		8/8 (100%)
Gastrointestinal disorders
Abdominal Pain	10/28 (35.7%)		5/8 (62.5%)
Diarrhea	4/28 (14.3%)		0/8 (0%)
Nausea	11/28 (39.3%)		2/8 (25%)
Vomiting	0/28 (0%)		2/8 (25%)
General disorders
Fever	2/28 (7.1%)		0/8 (0%)
Immune system disorders
Anaphylaxis	2/28 (7.1%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis	4/28 (14.3%)		0/8 (0%)
Cough	6/28 (21.4%)		0/8 (0%)
Sore Throat	2/28 (7.1%)		0/8 (0%)
Upper Respiratory Infection	3/28 (10.7%)		0/8 (0%)
Skin and subcutaneous tissue disorders
Pruritus	9/28 (32.1%)		0/8 (0%)
Rash Maculo-Papular	3/28 (10.7%)		0/8 (0%)
Urticaria	0/28 (0%)		2/8 (25%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.