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

NCT02879006 | Unknown Phase 2 DMC

• 1 other identifier: GCO 16-1384
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Food Allergy

Keywords

Chinese herbal therapy; Oral immunotherapy; Food allergy; Omalizumab

Outcome Measures

Primary Outcomes (1)

• Sustained unresponsiveness

  Sustained unresponsiveness evaluated by the absence of dose-limiting symptoms to a cumulative dose of 4,444 protein.

  month 29

Secondary Outcomes (2)

• Desensitizing to 4444mg

  month 26

• High level of desensitization to 7444mg or higher

  month 26

Study Arms (2)

Chinese Herbal Medication

ACTIVE COMPARATOR

Drug: Chinese Herbal Medication; Drug: Omalizumab; Drug: Multi OIT

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Omalizumab; Drug: Multi OIT

Interventions

Chinese Herbal Medication DRUG

Capsules, 26 month course, starting 2 months pre-OIT

Also known as: E-B-FAHF-2

Chinese Herbal Medication

Placebo DRUG

Placebo capsules that look identical to E-B-FAHF-2, 26 month course, starting 2 months pre-OIT

Also known as: Placebo Chinese Herb

Placebo

Omalizumab DRUG

4 months course, starting 2 months pre-OIT through the 2 month build-up phase

Also known as: Xolair®

Chinese Herbal Medication; Placebo

Multi OIT DRUG

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

Chinese Herbal Medication; Placebo

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiu-Min Li: lead

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 33310179 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Julie Wang, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professorial Lecturer

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)