Study Results
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
41 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-15
Study Completion Date
2024-02-19
Brief Summary
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The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
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Detailed Description
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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.
Conditions
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Cow's Milk Allergy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Placebo controlled
Study Groups
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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.
Group Type
EXPERIMENTAL
Baked non-fat cow's milk powder
Intervention Type
DRUG
Oral immunotherapy with increasing quantities of baked milk.
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.
Group Type
PLACEBO_COMPARATOR
Placebo: Tapioca Powder
Intervention Type
DRUG
Placebo control.
Interventions
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Baked non-fat cow's milk powder
Oral immunotherapy with increasing quantities of baked milk.
Intervention Type
DRUG
Placebo: Tapioca Powder
Placebo control.
Intervention Type
DRUG
Other Intervention Names
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Investigational New Drug (IND) 17114
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
3 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Myra Reinhardt Foundation
OTHER
Sponsor Role
collaborator
La Jolla Institute for Allergy & Immunology
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Robert Wood, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Site Status
Countries
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United States
References
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Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. Nutr Res. 2011 Jan;31(1):61-75. doi: 10.1016/j.nutres.2011.01.001. No abstract available.
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Gupta RS, Springston EE, Warrier MR, Smith B, Kumar R, Pongracic J, Holl JL. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011 Jul;128(1):e9-17. doi: 10.1542/peds.2011-0204. Epub 2011 Jun 20.
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Sicherer SH, Sampson HA. Food allergy: Epidemiology, pathogenesis, diagnosis, and treatment. J Allergy Clin Immunol. 2014 Feb;133(2):291-307; quiz 308. doi: 10.1016/j.jaci.2013.11.020. Epub 2013 Dec 31.
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Skripak JM, Matsui EC, Mudd K, Wood RA. The natural history of IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2007 Nov;120(5):1172-7. doi: 10.1016/j.jaci.2007.08.023. Epub 2007 Nov 1.
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Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
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Nowak-Wegrzyn A, Bloom KA, Sicherer SH, Shreffler WG, Noone S, Wanich N, Sampson HA. Tolerance to extensively heated milk in children with cow's milk allergy. J Allergy Clin Immunol. 2008 Aug;122(2):342-7, 347.e1-2. doi: 10.1016/j.jaci.2008.05.043. Epub 2008 Jul 11.
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Kim JS, Nowak-Wegrzyn A, Sicherer SH, Noone S, Moshier EL, Sampson HA. Dietary baked milk accelerates the resolution of cow's milk allergy in children. J Allergy Clin Immunol. 2011 Jul;128(1):125-131.e2. doi: 10.1016/j.jaci.2011.04.036. Epub 2011 May 23.
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Nelson HS, Lahr J, Rule R, Bock A, Leung D. Treatment of anaphylactic sensitivity to peanuts by immunotherapy with injections of aqueous peanut extract. J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):744-51. doi: 10.1016/s0091-6749(97)80006-1.
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Keet CA, Frischmeyer-Guerrerio PA, Thyagarajan A, Schroeder JT, Hamilton RG, Boden S, Steele P, Driggers S, Burks AW, Wood RA. The safety and efficacy of sublingual and oral immunotherapy for milk allergy. J Allergy Clin Immunol. 2012 Feb;129(2):448-55, 455.e1-5. doi: 10.1016/j.jaci.2011.10.023. Epub 2011 Nov 30.
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Martorell A, De la Hoz B, Ibanez MD, Bone J, Terrados MS, Michavila A, Plaza AM, Alonso E, Garde J, Nevot S, Echeverria L, Santana C, Cerda JC, Escudero C, Guallar I, Piquer M, Zapatero L, Ferre L, Bracamonte T, Muriel A, Martinez MI, Felix R. Oral desensitization as a useful treatment in 2-year-old children with cow's milk allergy. Clin Exp Allergy. 2011 Sep;41(9):1297-304. doi: 10.1111/j.1365-2222.2011.03749.x. Epub 2011 Apr 11.
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Narisety SD, Skripak JM, Steele P, Hamilton RG, Matsui EC, Burks AW, Wood RA. Open-label maintenance after milk oral immunotherapy for IgE-mediated cow's milk allergy. J Allergy Clin Immunol. 2009 Sep;124(3):610-2. doi: 10.1016/j.jaci.2009.06.025. Epub 2009 Aug 8.
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Pajno GB, Caminiti L, Ruggeri P, De Luca R, Vita D, La Rosa M, Passalacqua G. Oral immunotherapy for cow's milk allergy with a weekly up-dosing regimen: a randomized single-blind controlled study. Ann Allergy Asthma Immunol. 2010 Nov;105(5):376-81. doi: 10.1016/j.anai.2010.03.015. Epub 2010 Jul 31.
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Wood RA, Kim JS, Lindblad R, Nadeau K, Henning AK, Dawson P, Plaut M, Sampson HA. A randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy. J Allergy Clin Immunol. 2016 Apr;137(4):1103-1110.e11. doi: 10.1016/j.jaci.2015.10.005. Epub 2015 Nov 12.
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Goldberg MR, Nachshon L, Appel MY, Elizur A, Levy MB, Eisenberg E, Sampson HA, Katz Y. Efficacy of baked milk oral immunotherapy in baked milk-reactive allergic patients. J Allergy Clin Immunol. 2015 Dec;136(6):1601-1606. doi: 10.1016/j.jaci.2015.05.040. Epub 2015 Jul 17.
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Lin MS, Tanner E, Lynn J, Friday GA Jr. Nonfatal systemic allergic reactions induced by skin testing and immunotherapy. Ann Allergy. 1993 Dec;71(6):557-62.
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Devenney I, Falth-Magnusson K. Skin prick tests may give generalized allergic reactions in infants. Ann Allergy Asthma Immunol. 2000 Dec;85(6 Pt 1):457-60. doi: 10.1016/S1081-1206(10)62571-9.
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Valyasevi MA, Maddox DE, Li JT. Systemic reactions to allergy skin tests. Ann Allergy Asthma Immunol. 1999 Aug;83(2):132-6. doi: 10.1016/S1081-1206(10)62624-5.
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Bernstein DI, Wanner M, Borish L, Liss GM; Immunotherapy Committee, American Academy of Allergy, Asthma and Immunology. Twelve-year survey of fatal reactions to allergen injections and skin testing: 1990-2001. J Allergy Clin Immunol. 2004 Jun;113(6):1129-36. doi: 10.1016/j.jaci.2004.02.006.
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BACKGROUND
Dantzer JA, Lewis SA, Psoter KJ, Sutherland A, Frazier A, Richardson E, Maiche S, Seumois G, Peters B, Wood RA. Clinical and immunological outcomes after randomized trial of baked milk oral immunotherapy for milk allergy. JCI Insight. 2025 Jan 9;10(1):e184301. doi: 10.1172/jci.insight.184301.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB00099590
Identifier Type: -
Identifier Source: org_study_id
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