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

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ClinicalTrials.gov Identifier: NCT02879006
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Xiu-Min Li, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE August 22, 2016
First Posted Date  ICMJE August 25, 2016
Last Update Posted Date August 12, 2020
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
Sustained unresponsiveness [ Time Frame: month 29 ]
Sustained unresponsiveness evaluated by the absence of dose-limiting symptoms to a cumulative dose of 4,444 protein.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • Desensitizing to 4444mg [ Time Frame: month 26 ]
    Number of participants tolerating a cumulative dose of 4,444mg of food allergen protein.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy
Official Title  ICMJE Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • Drug: Chinese Herbal Medication
    Capsules, 26 month course, starting 2 months pre-OIT
    Other Name: E-B-FAHF-2
  • 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)
Study Arms  ICMJE
  • Active Comparator: Chinese Herbal Medication
    Interventions:
    • Drug: Chinese Herbal Medication
    • Drug: Omalizumab
    • Drug: Multi OIT
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: Omalizumab
    • Drug: Multi OIT
Publications * Wang Z, Wang ZZ, Geliebter J, Tiwari R, Li XM. Traditional Chinese medicine for food allergy and eczema. Ann Allergy Asthma Immunol. 2021 Jun;126(6):639-654. doi: 10.1016/j.anai.2020.12.002. Epub 2020 Dec 10. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 30, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2016)
34
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02879006
Other Study ID Numbers  ICMJE GCO 16-1384
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiu-Min Li, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Xiu-Min Li
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Wang, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP