Baked Milk Oral Immunotherapy for Cow's Milk Allergy

NCT03462030 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00099590
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Allergy

Keywords

food allergy; oral immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (7)

• Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment

  1 year

• Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment

  2 years

• Change in Maximum Tolerated Dose of Baked Milk

  Baseline, 1 year and 2 years

• Change in Milk-specific IgE Level

  Baseline and up to year 2

• Change in Milk-specific IgG4 Level

  Baseline and up to year 2

Study Arms (2)

Baked Milk Immunotherapy

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Baked non-fat cow's milk powder DRUG

Oral immunotherapy with increasing quantities of baked milk.

Also known as: Investigational New Drug (IND) 17114

Baked Milk Immunotherapy

Placebo: Tapioca Powder DRUG

Placebo control.

Placebo

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Myra Reinhardt Foundation: collaborator
• La Jolla Institute for Allergy & Immunology: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Interventions

Drugs, Investigational

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Robert Wood
• Organization: Johns Hopkins University

rwood@jhmi.edu

410-955-5883

Study Officials

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 12, 2018
• Study Start: March 15, 2018
• Primary Completion: January 25, 2021
• Study Completion: February 19, 2024
• Last Updated: February 4, 2025
• Results First Posted: December 3, 2021

Record last verified: 2025-01

Locations

US (1)