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E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02879006
Recruitment Status : Unknown
Verified August 2020 by Xiu-Min Li, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : August 12, 2020
Information provided by (Responsible Party):
Xiu-Min Li, Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to safely tolerate food allergens. Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for the treatment of food allergies in children and adults. Investigational means it has not been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness (which is the ability to consume a food allergen and pass an oral food challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: Chinese Herbal Medication Drug: Placebo Drug: Omalizumab Drug: Multi OIT Phase 2

Detailed Description:
Prior studies have shown that this Chinese herbal formulation is safe and well-tolerated in food allergic individuals. While oral immunotherapy (OIT) can lead to desensitization, it remains uncertain whether this treatment can lead to lasting protection. Therefore, this study aims to use the Chinese herbal formula in combination with OIT to determine whether sustained protection can be achieved. All subjects will receive multi-allergen OIT, along with a 4 month course of omalizumab to provide added safety for the initial dose escalation and build up phases. Subjects will be randomized to receive active Chinese herbal formula or placebo. Subjects will be treated with OIT for 2 years and then food challenges will be performed to assess for desensitization. For those who achieve desensitization, all treatments will be discontinued and food challenges will be performed 3 months later to assess for sustained unresponsiveness.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy
Study Start Date : August 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Active Comparator: Chinese Herbal Medication Drug: Chinese Herbal Medication
Capsules, 26 month course, starting 2 months pre-OIT
Other Name: E-B-FAHF-2

Drug: Omalizumab
4 months course, starting 2 months pre-OIT through the 2 month build-up phase
Other Name: Xolair®

Drug: Multi OIT
24 months of multi OIT (maintenance dose of 1gm each food allergen)

Placebo Comparator: Placebo Drug: Placebo
Placebo capsules that look identical to E-B-FAHF-2, 26 month course, starting 2 months pre-OIT
Other Name: Placebo Chinese Herb

Drug: Omalizumab
4 months course, starting 2 months pre-OIT through the 2 month build-up phase
Other Name: Xolair®

Drug: Multi OIT
24 months of multi OIT (maintenance dose of 1gm each food allergen)

Primary Outcome Measures :
  1. Sustained unresponsiveness [ Time Frame: month 29 ]
    Sustained unresponsiveness evaluated by the absence of dose-limiting symptoms to a cumulative dose of 4,444 protein.

Secondary Outcome Measures :
  1. Desensitizing to 4444mg [ Time Frame: month 26 ]
    Number of participants tolerating a cumulative dose of 4,444mg of food allergen protein.

  2. High level of desensitization to 7444mg or higher [ Time Frame: month 26 ]
    Number of participants tolerating a cumulative dose of 7,444mg or higher (max of 10,444mg) of food allergen protein

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 6 through 40 years
  • At least one of the following for each of the 3 study allergens: serum IgE >4 kU/L or skin prick test >6mm
  • dose limiting symptoms at a cumulative dose of <=444 mg protein for 3 allergens as screening double-blind, placebo-controlled food challenge
  • use of an effective method of contraception by females of child-bearing potential
  • ability to ingest oat or corn with no allergic reaction

Exclusion Criteria:

  • If baked milk or egg are tolerated (assessed by clinical report), then milk or egg may not be included as a study allergen
  • Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, and serious ventricular arrhythmias
  • History of other chronic disease requiring therapy (other than asthma, atopic dermatitis, or rhinitis)
  • History of eosinophilic gastrointestinal disease
  • Current participation in any other interventional study
  • Investigational drug use within 90 days
  • Subject is on build-up phase of any allergen immunotherapy (prior to maintenance dosing)
  • Current uncontrolled moderate to severe asthma as defined by:

    • FEV1 value <80% predicted (or PFR if unable to perform spirometry) or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines).
    • Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, having 1 burst or steroid course within the past 6 months, or having >1 burst oral steroid course within the past 12 months.
    • Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma.
  • Use of systemic steroid medications (IV, IM or oral) for indications other than asthma for > 3 weeks within the past 6 months
  • Inability to discontinue antihistamines for the initial day of escalation, skin testing or DBPCFC
  • Use of Xolair® (omalizumab) within the past 6 months
  • Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
  • Body weight more than 90 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 600 mg dosing
  • Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers
  • Pregnancy or lactation
  • Inability to swallow placebo capsules
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02879006

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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Xiu-Min Li
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Principal Investigator: Julie Wang, MD Icahn School of Medicine at Mount Sinai
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Xiu-Min Li, Professorial Lecturer, Icahn School of Medicine at Mount Sinai Identifier: NCT02879006    
Other Study ID Numbers: GCO 16-1384
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiu-Min Li, Icahn School of Medicine at Mount Sinai:
Chinese herbal therapy
Oral immunotherapy
Food allergy
Additional relevant MeSH terms:
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Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents