Milk Patch for Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02579876
• Date of registration: 14/10/2015
• Prospective Registration: No
• Primary sponsor: Children's Hospital of Philadelphia
• Public title: Milk Patch for Eosinophilic Esophagitis SMILEE
• Scientific title: A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children
• Date of first enrolment: October 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02579876
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Antonella Cianferoni, MD, PhD
• Affiliation: Children's Hospital of Philadelphia

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. Uncontrolled persistent asthma by National Asthma Education and Prevention
Program Asthma guidelines (2007).

2. at least two systemic corticosteroid courses for asthma in the past year or one
oral corticosteroid course for asthma in the past three months;

3. prior intubation for asthma in the past two years.

- Subjects on ß-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.

- Allergy or known hypersensitivity to placebo excipients either of the Viaskin® or
Tegaderm®.

- Subjects suffering from generalized dermatologic diseases with no intact skin zones to
apply the Viaskin®, or urticarial and mast cell disorders such as chronic idiopathic
urticaria.

- Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope
with the conditions of an upper endoscopy and biopsy.

- Past or current disease(s), which in the opinion the sponsor-investigator, may affect
the subject's participation in this study including but not limited to active
autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases
(hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g.,
liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood
disorders).

- Any history of drug or alcohol abuse in the past five years.

- Subjects unable to follow the protocol and the protocol requirements.

- Participation in another clinical intervention study in the three months prior to
Study Visit 1.

- Subjects on any experimental drugs or treatments.



Age minimum: 4 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Milk Allergy

Intervention(s)

Drug: Viaskin Milk 500 mcg

Drug: Viaskin Placebo

Primary Outcome(s)

Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population) [Time Frame: 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) [Time Frame: Month 11(end of double blind phase)]

Secondary Outcome(s)

Pediatric Eosinophil Esophagitis Symptom Score (PP Population) [Time Frame: Month 11, End of Double Blind Placebo Control]

Eosinophilic Esophagitis Symptom Score (Intent to Treat Population) [Time Frame: Total Symptom Score at End of DB Phase, Month 11]

Pediatric Eosinophilic Esophagitis Symptom Score (ITT) [Time Frame: Month 11, end of Double Blind Phase]

Endoscopy Score (Per Protocol Patients) [Time Frame: Month 11 (end of double blind phase)]

Esophageal Endoscopy Score (ITT) [Time Frame: At end of DB phase, at 11 months]

Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients [Time Frame: End of DB Phase, at 11 months]

Secondary ID(s)

13-010148

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DBV Technologies

Results

• Results available: Yes
• Date Posted: 10/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02579876