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

NCT06103656 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 02879006
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is testing the use of Enhanced-Butanol purified-Food Allergy Herbal Formula-2 (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

Outcome Measures

Primary Outcomes (1)

• Sustained unresponsiveness to cumulative dose of 4,444 mg protein

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

  29 months

Secondary Outcomes (2)

• Desensitization to 4444mg protein

  26 months

• High level desensitization to 7444mg protein or higher

  26 months

Study Arms (2)

Active Comparator::Chinese Herbal Medication

EXPERIMENTAL

Interventions: \- Drug: Chinese Herbal Medication (E-B-FAHF-2), dose level was determined using the subject's weight at the screening visit (\>20-30 kg = 5 capsules daily, \>30-70 kg = 8 capsules daily, and \>70 kg = 10 capsules daily)

Drug: Drug: Chinese Herbal Medication; Drug: Drug: Omalizumab

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Interventions: * Drug: Placebo. Placebo capsules were identical in appearance but contained corn starch * Drug: Omalizumab. Omalizumab was dosed as per the product insert * Drug: Multi OIT. An initial rush dose to a maximum of 250 mg of protein of each allergen (total 270 mg of protein) and up-dosing every 2 weeks until the maintenance dose of 1000mg was reached.

Drug: Drug: Placebo

Interventions

Drug: Chinese Herbal Medication DRUG

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

Also known as: E-B-FAFH-2

Active Comparator::Chinese Herbal Medication

Drug: Placebo DRUG

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

Also known as: Placebo Chinese Herb

Placebo Comparator: Placebo

Drug: Omalizumab DRUG

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

Also known as: Xolair®

Active Comparator::Chinese Herbal Medication

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 immunoglobulin E (IgE) \>4000 U/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:
• Forced Expiratory Volume-1 (FEV1) value \<80% predicted 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 Emergency Department (ED) visit in the past 6 months for asthma.
• Use of systemic steroid medications (Intravenous, Intramuscular 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

• New York Medical College: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Related Publications (1)

• Wang J, Wood RA, Raymond S, Suarez-Farinas M, Yang N, Sicherer SH, Sampson HA, Li XM. Double-Blind, Placebo-Controlled Study of E-B-FAHF-2 in Combination With Omalizumab-Facilitated Multiallergen Oral Immunotherapy. J Allergy Clin Immunol Pract. 2023 Jul;11(7):2208-2216.e1. doi: 10.1016/j.jaip.2023.03.051. Epub 2023 Apr 20.

  PMID: 37087097 RESULT

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 27, 2023
• Study Start: August 20, 2016
• Primary Completion: July 2, 2020
• Study Completion: February 22, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share