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Food AllergyPhase 2NCT02879006

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

A Phase 2 study testing Chinese Herbal Medication, Omalizumab and Multi OIT in people with Food Allergy, run by Xiu-Min Li at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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?
Chinese Herbal Medication, Omalizumab and Multi OIT
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
2 sitesUnited States
Study dates
Aug 2016to Nov 2020
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 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

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:
  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

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 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
Chinese Herbal Medication, Placebo, Omalizumab, Multi OIT
Keywords
Chinese herbal therapy, Oral immunotherapy, Food allergy, 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.

  • Chinese Herbal MedicationDrug

    Also called E-B-FAHF-2

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

  • PlaceboDrug

    Also called Placebo Chinese Herb

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

  • OmalizumabDrug

    Also called Xolair®

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

  • Multi OITDrug

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

Study groups in NCT02879006
Study groupRoleWhat they receive
Chinese Herbal MedicationActive comparatorNot described
Receives: Drug: Chinese Herbal Medication; Drug: Omalizumab; Drug: Multi OIT
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Omalizumab; Drug: Multi OIT

What is being measured

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

  1. Sustained unresponsiveness

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

    Measured: month 29

Secondary outcomes (2)

  1. Desensitizing to 4444mg

    Number of participants tolerating a cumulative dose of 4,444mg of food allergen protein.

    Measured: month 26

  2. High level of desensitization to 7444mg or higher

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

    Measured: month 26

Timeline

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

  1. First posted25 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionNov 2020 (estimated)
  4. Study completionNov 2020 (estimated)

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
NCT02879006
Sponsor's protocol ID
GCO 16-1384
Status last verified
Aug 2020
First submitted
22 Aug 2016
Last updated
12 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 33310179

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chinese Herbal Medication, Omalizumab and Multi OIT in people with Food Allergy, run by Xiu-Min Li at 2 sites in United States.

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: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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 (time frame: month 29). 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 NCT02879006, 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 12 Aug 2020.

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