Clinical trial NCT03462030: Baked Milk Oral Immunotherapy for Cow's Milk Allergy
Official title: Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cow's Milk Allergy
Keywords: food allergy
oral immunotherapy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Myra Reinhardt Foundation
name: La Jolla Institute for Allergy & Immunology
First posted: 2018-03-12
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.

Detailed description: This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.

Eligibility criteria: Inclusion Criteria:

* Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:

  * Are age 3-18 years, either sex, any ethnicity or race
  * Provide signed informed consent by parent or legal guardian and informed assent if applicable
  * Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial, upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral symptoms)
  * Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative control) and serum milk-specific immunoglobulin E (IgE) level \>5 kilo Units (kU)/L within the past 6-12 months
  * Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in the initial qualifying double blind placebo-controlled food challenge.
  * Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  * Have self-injectable epinephrine available at all times

Exclusion Criteria:

* Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:

  * Have a history of severe anaphylaxis resulting in hypotension, neurological compromise, or mechanical ventilation
  * Have a history of intubation related to asthma
  * Tolerate more than 444 mg of baked milk powder at the initial qualifying double blind placebo controlled food challenge.
  * Allergy to placebo ingredients or reacts to any dose of placebo during the qualifying oral food challenge.
  * Poor control of atopic dermatitis
  * Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day
  * Are pregnant or lactating
  * Have severe asthma defined by 2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5 or 6
  * Have severe or poorly controlled asthma defined by with any of the following criteria:

    1. Forced expiratory volume in 1 second (FEV1) \<80% of predicted
    2. Inhaled corticosteroid dosing dosing of \>500 mcg daily of fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
    3. ≥ 1 hospitalization in the past year for asthma or
    4. \> 1 emergency department visit in the past 6 months for asthma
  * Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the following manners: History of daily oral steroid dosing within 4 weeks prior to baseline visit or for \> 1 month during the past year or \>2 burst oral steroid courses in the past 6 months.
  * Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
  * Are receiving omalizumab, mepolizumab, beta- blocker, angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers, calcium channel blockers, or tricyclic antidepressant therapy
  * Have used immunomodulatory therapy (not including corticosteroids) or biologic therapy within the past year
  * Have participated in any interventional study for treatment of a food allergy in the past 6 months
  * Are on 'build up phase' of environmental allergen immunotherapy. Subjects tolerating maintenance allergen immunotherapy can be enrolled.
  * Have a history of eosinophilic esophagitis in the past 3 years
  * Have a chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
  * Have used an investigational drug within 90 days or plan to use an investigational drug during the study period
  * Severe reaction at initial double blind placebo controlled food challenge, defined as:

    * Life-threatening anaphylaxis
    * Requiring overnight hospitalization

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
timeFrame: 1 year
measure: Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
timeFrame: 2 years
measure: Change in Maximum Tolerated Dose of Baked Milk
timeFrame: Baseline, 1 year and 2 years
measure: Change in Milk-specific IgE Level
timeFrame: Baseline and up to year 2
measure: Change in Milk-specific IgG4 Level
timeFrame: Baseline and up to year 2
measure: Change in Milk Skin Prick Test Responses
timeFrame: Baseline and up to year 2
measure: Change in Quality of Life as Assessed by the Food Allergy Questionnaire
timeFrame: Baseline and up to year 2
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert Wood, MD
role: PRINCIPAL_INVESTIGATOR
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