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Baked Milk Oral Immunotherapy for Cow's Milk Allergy

Primary Purpose

Cow's Milk Allergy

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Baked non-fat cow's milk powder
Placebo: Tapioca Powder
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow's Milk Allergy focused on measuring food allergy, oral immunotherapy

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baked Milk Immunotherapy

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
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

Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
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 baked milk protein after one year of baked milk oral immunotherapy. This measure reports the number of participants that were able to tolerate 4 grams of baked milk protein.
Proportion of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
The investigators will perform unheated milk challenges to up to 8000 mg of unheated milk protein and calculate the proportion of subjects who tolerate 2 grams of unheated milk protein after 2 years of treatment. This measure reports the number of participants that were able to tolerate 2 grams of unheated milk protein.
Change in Maximum Tolerated Dose of Baked Milk
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
Change in Milk-specific IgE Level
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
Change in Milk-specific IgG4 Level
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
Change in Milk Skin Prick Test Responses
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.

Full Information

First Posted
February 28, 2018
Last Updated
November 7, 2022
Sponsor
Johns Hopkins University
Collaborators
Myra Reinhardt Foundation, La Jolla Institute for Allergy & Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT03462030
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
January 25, 2021 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Myra Reinhardt Foundation, La Jolla Institute for Allergy & Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
Keywords
food allergy, oral immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo controlled
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baked Milk Immunotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Baked non-fat cow's milk powder
Other Intervention Name(s)
Investigational New Drug (IND) 17114
Intervention Description
Oral immunotherapy with increasing quantities of baked milk.
Intervention Type
Drug
Intervention Name(s)
Placebo: Tapioca Powder
Intervention Description
Placebo control.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
Description
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 baked milk protein after one year of baked milk oral immunotherapy. This measure reports the number of participants that were able to tolerate 4 grams of baked milk protein.
Time Frame
1 year
Title
Proportion of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
Description
The investigators will perform unheated milk challenges to up to 8000 mg of unheated milk protein and calculate the proportion of subjects who tolerate 2 grams of unheated milk protein after 2 years of treatment. This measure reports the number of participants that were able to tolerate 2 grams of unheated milk protein.
Time Frame
2 years
Title
Change in Maximum Tolerated Dose of Baked Milk
Description
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
Time Frame
Baseline, 1 year and 2 years
Title
Change in Milk-specific IgE Level
Description
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
Time Frame
Baseline and up to year 4
Title
Change in Milk-specific IgG4 Level
Description
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
Time Frame
Baseline and up to year 4
Title
Change in Milk Skin Prick Test Responses
Description
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
Time Frame
Baseline and up to year 4
Title
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
Description
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.
Time Frame
Baseline and up to year 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Forced expiratory volume in 1 second (FEV1) <80% of predicted Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or ≥ 1 hospitalization in the past year for asthma or > 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Baked Milk Oral Immunotherapy for Cow's Milk Allergy

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