Milk Patch for Eosinophilic Esophagitis

NCT02579876 | Completed Phase 2 Results DMC

• 1 other identifier: 13-010148
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE). 20 subjects will be randomized 3:1 to Viaskin® Milk or placebo patch.

Conditions

Eosinophilic Esophagitis; Milk Allergy

Keywords

Milk Allergy; Viaskin Milk; Epicutaneous ImmunoTherapy (EPIT); Eosinophilic Esophagitis; Milk-Induced Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (2)

• Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population)

  Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.

  From baseline to month 11 (end of double blind phase)

• Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients)

  Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels). The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated.

  Month 11(end of double blind phase)

Secondary Outcomes (6)

• Eosinophilic Esophagitis Symptom Score (Intent to Treat Population)

  Total Symptom Score at End of DB Phase, Month 11

• Esophageal Endoscopy Score (ITT)

  At end of DB phase, at 11 months

• Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients

  End of DB Phase, at 11 months

• Pediatric Eosinophilic Esophagitis Symptom Score (ITT)

  Month 11, end of Double Blind Phase

• Endoscopy Score (Per Protocol Patients)

  Month 11 (end of double blind phase)

Study Arms (2)

Viaskin Milk 500 mcg

ACTIVE COMPARATOR

Viaskin patch containing milk protein. The patch is applied to the skin

Drug: Viaskin Milk 500 mcg

Viaskin Placebo

PLACEBO COMPARATOR

Viaksin patch without any milk protein.

Drug: Viaskin Placebo

Interventions

Viaskin Milk 500 mcg DRUG

Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.

Also known as: Milk Patch, Viaskin Epicutaneous ImmunoTherapy (EPIT)

Viaskin Milk 500 mcg

Viaskin Placebo DRUG

Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.

Also known as: Placebo Patch, Placebo Epicutaneous ImmunoTherapy (EPIT)

Viaskin Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Well-documented medical history of Eosinophilic Esophagitis after ingestion of milk and currently following a strict milk-free diet.
• Upper endoscopy and biopsy at initial clinical evaluation during Visit 2 showing greater than 15 eosinophils/high power field (HPF) isolated to the esophagus meeting the consensus diagnosis of Eosinophilic Esophagitis, after milk was re-introduced into the subject's diet (30 ml/day for 1 week to 2 months), while the subject was on proton pump inhibitor.
• Upper endoscopy and biopsy at second clinical evaluation during Visit 3 showing less than 5 eosinophils per HPF isolated to the esophagus after a minimum of 6 weeks under milk-free diet, and while the subject is on proton pump inhibitor.
• Negative pregnancy test for female subjects of childbearing potential. Females of childbearing potential must use effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 18 years of age.
• Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.
• Signed informed consent from parent(s)/guardian(s) of children \< 18 years + children's assent.
• Subjects agree to maintain a constant diet during the trial, with the exception of milk.
• Subjects will maintain constant medications for asthma and allergic rhinitis during the trial.

You may not qualify if:

• Subjects with a history of severe anaphylaxis to milk with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence), Quincke Edema or requiring intubation.
• Active IgE- mediated milk allergy.
• Pregnancy or lactation.
• Subjects with other eosinophilic gastrointestinal disorders.
• Subjects on swallowed corticosteroids or anti-leukotrienes for Eosinophilic Esophagitis.
• Subjects with symptomatic allergy to pollens whose symptoms during the corresponding pollen season might interfere with the recording of symptoms during the upper endoscopy/biopsy, if the upper endoscopy/biopsy is conducted during the pollen season. The Investigator will have to ensure that the period for conducting the upper endoscopy for such a subject will be outside of the pollen season.
• Subjects treated with systemic long-acting corticosteroids (depot corticosteroids) within 12 weeks prior to Visit 1 and/or systemic short-acting corticosteroid within 4 weeks prior to Visit 1 or any systemic corticosteroid at screening.
• Subjects with asthma conditions defined as follows:
• Uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007).
• at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months;
• prior intubation for asthma in the past two years.
• Subjects on β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
• Subjects undergoing any type of immunotherapy to any food within one year prior to Visit 1.
• Subjects presently on aeroallergen immunotherapy and unwilling or unable to discontinue.
• Subjects currently treated with anti-tumor necrosis factor drugs or anti-Immunoglobulin E (IgE) drugs or any biologic immunomodulatory therapy within one year prior to Visit 1.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• DBV Technologies: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Spergel JM, Elci OU, Muir AB, Liacouras CA, Wilkins BJ, Burke D, Lewis MO, Brown-Whitehorn T, Cianferoni A. Efficacy of Epicutaneous Immunotherapy in Children With Milk-Induced Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2020 Feb;18(2):328-336.e7. doi: 10.1016/j.cgh.2019.05.014. Epub 2019 May 14.

  PMID: 31100455 DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Food Hypersensitivity

Results Point of Contact

• Title: Jonathan Spergel
• Organization: The Children's Hospital of Philadelphia

spergel@email.chop.edu

215 590 1000

Study Officials

• Antonella Cianferoni, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: December 20, 2017
• Study Completion: November 20, 2018
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)