Baked Milk Oral Immunotherapy for Cow's Milk Allergy

February 20, 2024 updated by: Johns Hopkins University

Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment
Time Frame: 1 year
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.
1 year
Proportion of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment
Time Frame: 2 years
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.
2 years
Change in Maximum Tolerated Dose of Baked Milk
Time Frame: Baseline, 1 year and 2 years
Change in maximum tolerated dose (milligrams) of baked milk from baseline to end of year 1 and end of year 2.
Baseline, 1 year and 2 years
Change in Milk-specific IgE Level
Time Frame: Baseline and up to year 4
Change in milk-specific immunoglobulin E (IgE) level measured in kU/L.
Baseline and up to year 4
Change in Milk-specific IgG4 Level
Time Frame: Baseline and up to year 4
Change in milk-specific immunoglobulin G4 (IgG4) level measured in mg/L.
Baseline and up to year 4
Change in Milk Skin Prick Test Responses
Time Frame: Baseline and up to year 4
Change in milk skin prick test responses measured as a change in wheal size in millimeters.
Baseline and up to year 4
Change in Quality of Life as Assessed by the Food Allergy Questionnaire
Time Frame: Baseline and up to year 4
The food allergy questionnaire has an overall score range of 0-6 with 6 indicating the worst quality of life.
Baseline and up to year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

La Jolla Institute for Allergy & Immunology
Myra Reinhardt Foundation

Investigators

  • Principal Investigator: Robert Wood, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

January 25, 2021

Study Completion (Actual)

February 19, 2024

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00099590

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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