AzTrials
AzTrials

Food AllergyPhase 2FAHF-2NCT06103656

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

A Phase 2 study testing Drug: Chinese Herbal Medication and Drug: Omalizumab in people with Food Allergy, run by New York Medical College.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 40 years
Conditions the study is for
Food Allergy
What is being tested?
Drug: Chinese Herbal Medication and Drug: Omalizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
No sites listed yet
Study dates
20 Aug 2016to 22 Feb 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 6 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • 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), Angiotensinogen converting enzyme (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

About this study

Official title: Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy

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.

Read the 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.

Conditions
Food Allergy
Being tested
Drug: Chinese Herbal Medication, Drug: Placebo, Drug: Omalizumab
Medical subject headings
Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: Chinese Herbal MedicationDrug

    Also called E-B-FAFH-2

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

  • Drug: PlaceboDrug

    Also called Placebo Chinese Herb

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

  • Drug: OmalizumabDrug

    Also called Xolair®

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

Study groups in NCT06103656
Study groupRoleWhat they receive
Active Comparator::Chinese Herbal MedicationExperimentalInterventions: - 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)
Receives: Drug: Drug: Chinese Herbal Medication; Drug: Drug: Omalizumab
Placebo Comparator: PlaceboPlacebo comparatorInterventions: * 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.
Receives: Drug: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 29 months

Secondary outcomes (2)

  1. Desensitization to 4444mg protein

    Number of participants in the E-B-FAFH-2 group (EOIT) tolerating a cumulative dose of 4,4444mg of food allergen protein.

    Measured: 26 months

  2. High level desensitization to 7444mg protein or higher

    Number of participants tolerating a cumulative dose of 7,444mg or higher (max of 10,444mg) to food allergen protein

    Measured: 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start20 Aug 2016
  3. Primary completion2 Jul 2020
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06103656
Sponsor's protocol ID
02879006
Acronym
FAHF-2
Status last verified
Mar 2024
First submitted
20 Sep 2023
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37087097

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: Chinese Herbal Medication and Drug: Omalizumab in people with Food Allergy, run by New York Medical College.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained unresponsiveness to cumulative dose of 4,444 mg protein (time frame: 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06103656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in