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

Study Purpose

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.#46; OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 40 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02879006
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xiu-Min Li
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julie Wang, MD
Principal Investigator Affiliation	Icahn School of Medicine at Mount Sinai
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Chinese Herbal Medication

Placebo Comparator: Placebo

Interventions

Drug: - Chinese Herbal Medication

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

Drug: - Placebo

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

Drug: - Omalizumab

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

Drug: - Multi OIT

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins University, Baltimore, Maryland

Status

Address

Johns Hopkins University

Baltimore, Maryland, 21287

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

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