Trial Search Results

Clinical Study Using Biologics to Improve Multi OIT Outcomes

Food allergy (FA) is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and 3-5% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT in participants with proven allergies to up to 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 160, ages 4 to 21 years with a history of multiple food allergies of up to 3 different foods including peanut. An additional 20 multi-food allergic participants and 20 non-allergic controls that will not undergo OIT, will be followed to help interpret immune mechanisms of OIT. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive at or before the 100 mg (144 mg cumulative) a dosing level of FA proteins.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Omalizumab
  • Drug: Dupilumab
  • Other: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Age 6 through 21 years (inclusive).

   - Clinical history of peanut allergy and 1-2 additional foods from the following foods:
   milk, almond, cashew, hazelnut, pecan, walnut, sesame seeds, soy, and wheat.

   - Positive allergy test determined by:

   - ImmunoCAP serum IgE level >4 kUA/L for each allergen within the past 12 months OR

   - Skin prick test (SPT) ≥6 mm wheal diameter to each allergen.

   - A clinical reaction during a PRACTALL DBPCFC to small doses of food defined as a dose
   of =/<144 mg food protein.

   - No clinical reaction observed during the placebo (oat) challenge.

   - Written informed consent from adult participants.

   - Written informed consent from parent/guardian for minor participants.

   - Written assent from minor participants as appropriate (e.g., above the age of 7 years
   or the applicable age per local regulatory requirements).

   - Use of effective birth control by female participants of childbearing potential.

Exclusion Criteria:

   - History of cardiovascular disease, including uncontrolled or inadequately controlled
   hypertension.

   - History of severe or life-threatening episode of anaphylaxis or anaphylactic shock
   within 60 days of Screening.

   - History of chronic disease (other than asthma, atopic dermatitis or allergic rhinitis)
   that is, or is at significant risk of becoming, unstable or requiring a change in
   chronic therapeutic regimen.

   - History of eosinophilic esophagitis (EoE), another eosinophilic gastrointestinal
   disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD),
   symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or
   recurrent gastrointestinal symptoms of undiagnosed etiology.

   - Severe asthma (2007 NHLBI Criteria Steps 5 or 6) Mild or moderate asthma (2007 NHLBI
   Criteria Steps 1-4), if uncontrolled or difficult to control.

   - Inability to tolerate biological (antibody) therapies.

   - Use of immunomodulator therapy (not including corticosteroids).

Ages Eligible for Study

6 Years - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sharon Chinthrajah, M.D.
650-723-5227