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Baked Milk Oral Immunotherapy for Cow's Milk Allergy

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ClinicalTrials.gov Identifier: NCT03462030
Recruitment Status : Enrolling by invitation
First Posted : March 12, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
Myra Reinhardt Foundation
La Jolla Institute for Allergy & Immunology
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Cow's Milk Allergy Drug: Baked non-fat cow's milk powder Drug: Placebo: Tapioca Powder Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo controlled
Primary Purpose: Treatment
Official Title: Phase I Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Baked Milk Immunotherapy
Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Drug: Baked non-fat cow's milk powder
Oral immunotherapy with increasing quantities of baked milk.
Other Name: Investigational New Drug (IND) 17114

Placebo Comparator: Placebo
Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Drug: Placebo: Tapioca Powder
Placebo control.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: End of year 1 ]
    Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.


Secondary Outcome Measures :
  1. Change in the proportion of subjects who are able to tolerate 4 grams of baked milk protein after one and two years of treatment [ Time Frame: End of study year 1 and the end of study year 2 ]
    The investigators will perform baked milk challenges to 4044 mg of baked milk protein and calculate the proportion of subjects who tolerate 4 grams of unheated milk protein after one and two years of baked milk oral immunotherapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 kiloUnits (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462030


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Myra Reinhardt Foundation
La Jolla Institute for Allergy & Immunology
Investigators
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Principal Investigator: Robert Wood, MD Johns Hopkins University

Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03462030     History of Changes
Other Study ID Numbers: IRB00099590
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
food allergy
oral immunotherapy

Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs