Omalizumab in the Treatment of Peanut Allergy

NCT00949078 | Completed Phase 2 Results DMC

• 2 other identifiers: NA_000263971U19AI070345
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergy; Peanut Allergy

Keywords

peanut; allergy

Outcome Measures

Primary Outcomes (9)

• 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

  up to 6 months

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

  percentage

  change from baseline to up to 6 months

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

  kU/L (range)

  up to 6 months

• Total Immunoglobulin E (IgE) After Pn-BHR Response

  kU/L (range)

  up to 6 months

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

  mg

  up to 8 weeks

• Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2

  mg

  up to 8 weeks

• Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3

  mg

  up to 8 weeks

• Omalizumab Received Before OFC 2

  Number of doses

  up to 6 months

• Omalizumab Received Before OFC 2

  total mg

  up to 6 months

Study Arms (2)

Open Label Omalizumab Group A

EXPERIMENTAL

Omalizumab 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.

Drug: omalizumab

Open Label Omalizumab Group B

EXPERIMENTAL

Omalizumab 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.

Drug: omalizumab

Interventions

omalizumab DRUG

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

Also known as: Xolair

Open Label Omalizumab Group A; Open Label Omalizumab Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 12637608 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Nut and Peanut Hypersensitivity

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

Results Point of Contact

• Title: Professor Robert Wood, M.D.
• Organization: Johns Hopkins University School of Medicine

rwood@jhmi.edu

rwood@jhmi.edu

Study Officials

• Robert A Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Sarbjit Saini, MD

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Locations

US (1)