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Food AllergyPhase 2NCT00949078

Omalizumab in the Treatment of Peanut Allergy

A Phase 2 study testing omalizumab in people with Food Allergy and Peanut Allergy, run by Johns Hopkins University at 1 site in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Food Allergy, Peanut Allergy
What is being tested?
omalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Jul 2009to Aug 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or Female (non-pregnant), age 18-50
  • Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using one of the following medically acceptable forms of birth control throughout the duration of the study:
  • Systemic contraceptives
  • Diaphragm with intravaginal spermicide
  • Cervical cap
  • Intrauterine device
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  • Condom with intravaginal spermicide Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.
  • Females, excluding those more than 1 year postmenopausal or who are surgically sterile, must have a negative urine pregnancy test at Visit 1 and other visits specified in this protocol. If a subject becomes pregnant during the study participation, they will be discharged from the study and followed for any adverse events until termination of the pregnancy or delivery is complete. Given that the drug is in pregnancy category B, we will follow the pregnant mother for any adverse events for the duration of the study.
  • Physician diagnosed peanut allergy OR convincing clinical history of peanut allergy with its onset in early childhood.
  • Positive puncture skin test to peanut greater than or equal to 3 mm diluent control
  • Positive ImmunoCAP to peanut ≥0.35 kU/L.
  • In vitro basophil responsiveness to peanut allergen, with greater than 20% histamine release or 10-19% if greater than 50% of an optimal anti-IgE response (at baseline visit).
  • Subjects must have a positive oral food challenge to peanut as defined by having objective signs of a clear allergic reaction at a cumulative dose of peanut protein <1000 mg. Objective allergic signs may include oral urticaria, cutaneous urticaria, rhinorrhea, sneezing, coughing, wheezing, or vomiting.

Who cannot join

  • Asthma with Forced Expiatory Volume in 1 second (FEV1) < 80% predicted or severe persistent asthma per National Asthma Education and Prevention Program (NAEPP) Standards (2007 National Asthma Education and Prevention Program Expert Panel Report III guidelines) or poorly controlled asthma with oral corticosteroid use for exacerbation in last 6 months.
  • History of severe allergic reaction to peanut requiring intubation or ICU admission.
  • Late onset peanut allergy, defined as subjects who had previously tolerated peanut on a regular basis before their initial reaction.
  • Patients with biopsy proven eosinophilic enteropathy will be excluded.
  • Patients with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded.
  • Patients with hematocrit < 32%, White Blood Cell (WBC) count <4000/microliter, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or Aspartate Aminotransferase (AST) > 100 IU/L will be excluded if these abnormalities are present at the time of enrollment.
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  • Body weight less than 30 kg or greater than 150 kg at enrollment will be excluded.
  • Patients with plans to become pregnant or breastfeed will be excluded from the study. Patients must indicate they will use methods to avoid pregnancy.
  • Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions.
  • Current or prior use of omalizumab in the past 12 months.
  • Use of non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator (not including corticosteroids) or biologic therapy within the past year.
  • Use of beta-blockers (oral or ocular), angiotensin-converting enzyme (ACE) inhibitors, or angiotensin-receptor blockers (ARB) within 72 hours prior to either of the qualification Oral Food Challenge (OFC).
  • Use of antihistamines (within 3 days for short acting and 5 days for long acting) prior to the screening OFC.
  • Use of antihistamines (within 3 days for short acting and 5 days for long acting) prior to the study OFC. These procedures should be rescheduled when off antihistamines for the required time.
  • Inability to discontinue antihistamines for routine study tests.
  • History of ischemic cardiovascular disease (i.e., previous Myocardial Infarction, angina etc) or uncontrolled hypertension.
  • Significant upper respiratory tract infection (URI) within 7 days of any OFC; OFCs should be rescheduled within 7 days following resolution of URI.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • Use of any investigational drugs within 8 weeks of participation.
  • Any contraindication to omalizumab including patients with a previous hypersensitivity to omalizumab.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Effects of Omalizumab on Peanut Allergen Induced Cellular and Clinical Responses in Peanut Allergic Adults

The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.

Read the detailed description

The study will evaluate if omalizumab is an effective treatment for peanut allergy. In addition we will further evaluate the role of allergic cells (mast cells and basophils) and IgE in food allergy.

Being tested
omalizumab
Keywords
peanut, allergy
Medical subject headings
Food Hypersensitivity, Peanut Hypersensitivity, Hypersensitivity

What participants receive

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

  • omalizumabDrug

    Also called Xolair

    omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE

Study groups in NCT00949078
Study groupRoleWhat they receive
Open Label Omalizumab Group AExperimentalOmalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
Receives: Drug: omalizumab
Open Label Omalizumab Group BExperimentalOmalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
Receives: Drug: omalizumab

What is being measured

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

  1. Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8

    Presence or absence of this change

    Measured: up to 6 months

  2. Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response

    percentage

    Measured: change from baseline to up to 6 months

  3. Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response

    kU/L (range)

    Measured: up to 6 months

  4. Total Immunoglobulin E (IgE) After Pn-BHR Response

    kU/L (range)

    Measured: up to 6 months

  5. Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1

    mg

    Measured: up to 8 weeks

  6. Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2

    mg

    Measured: up to 8 weeks

  7. Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3

    mg

    Measured: up to 8 weeks

  8. Omalizumab Received Before OFC 2

    Number of doses

    Measured: up to 6 months

  9. Omalizumab Received Before OFC 2

    total mg

    Measured: up to 6 months

Timeline

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

  1. First posted30 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2011
  4. Study completionAug 2011

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949078
Sponsor's protocol ID
NA_00026397
Other IDs
1U19AI070345
Status last verified
Jun 2017
First submitted
29 Jul 2009
Last updated
12 Jul 2017
Data monitoring committee
Yes

Publications

  • Leung DY, Sampson HA, Yunginger JW, Burks AW Jr, Schneider LC, Wortel CH, Davis FM, Hyun JD, Shanahan WR Jr; Avon Longitudinal Study of Parents and Children Study Team. Effect of anti-IgE therapy in patients with peanut allergy. N Engl J Med. 2003 Mar 13;348(11):986-93. doi: 10.1056/NEJMoa022613. Epub 2003 Mar 10.

    PubMed 12637608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing omalizumab in people with Food Allergy and Peanut Allergy, run by Johns Hopkins University at 1 site 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 13 inclusion and 21 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 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8 (time frame: up to 6 months). The study lists 9 primary outcomes in all. 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 NCT00949078, 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 Jul 2017.

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