Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy

NCT02223182 | Completed Phase 1 Results DMC

• 1 other identifier: MILES
• Study Type: interventional
• Target: 198
• Locations: 2 countries
• Sites: 17

Brief Summary

The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.

Conditions

Food Allergy

Keywords

Milk Allergy,; Viaskin Milk,; Specific Immunotherapy,; Epicutaneous ImmunoTherapy (EPIT); IgE-Mediated Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of Subjects Who Are Treatment Responders After 12 Months of EPIT Treatment.

  A treatment responder is defined as a subject who meets at least one of the following criteria: * A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; * A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.

  From baseline to Month 12 (double-blind period)

Secondary Outcomes (12)

• Mean Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.

  From baseline to Month 12 (double-blind period)

• Median Cumulative Reactive Dose (CRD) of Cow's Milk Proteins.

  From baseline to Month 12 (double-blind period)

• Change in Levels of sIgE to Cow's Milk.

  From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

• Change in Levels of sIgG4 to Cow's Milk.

  From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

• Change in Levels of sIgE to Caseins, α-lactalbumin and β-lactoglobulin

  From baseline to Week 3, Month 3, Month 6, Month 12 (double-blind period)

Study Arms (4)

Viaskin Milk 150 mcg

EXPERIMENTAL

One Viaskin epicutaneous delivery system (patch) containing 150µg of cow's milk proteins applied each day for 12 months.

Biological: Viaskin Milk 150 mcg

Viaskin Milk 300 mcg

EXPERIMENTAL

One Viaskin epicutaneous delivery system (patch) containing 300µg of cow's milk proteins applied each day for 12 months.

Biological: Viaskin Milk 300 mcg

Viaskin Milk 500 mcg

EXPERIMENTAL

One Viaskin epicutaneous delivery system (patch) containing 500µg of cow's milk proteins applied each day for 12 months.

Biological: Viaskin Milk 500 mcg

Viaskin Placebo

PLACEBO COMPARATOR

One Viaskin epicutaneous delivery system (patch) containing placebo applied each day for 12 months.

Biological: Viaskin Placebo

Interventions

Viaskin Milk 150 mcg BIOLOGICAL

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.

Viaskin Milk 150 mcg

Viaskin Milk 300 mcg BIOLOGICAL

Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.

Viaskin Milk 300 mcg

Viaskin Milk 500 mcg BIOLOGICAL

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

Viaskin Milk 500 mcg

Viaskin Placebo BIOLOGICAL

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

Viaskin Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed Informed Consent Form (ICF) by parent(s)/guardian(s) of subjects and informed assent form (IAF) for subjects ≥7 years, or as per local or country specific guidelines or regulations.
• Male or female subjects 2 to 17 years old at Visit 1.
• Documented medical history or physician-confirmed diagnosis of IgE-mediated CMA with systemic symptoms related to ingestion of milk or dairy products.
• Subjects currently following a strict cow's milk-free diet, with no consumption of dairy or baked milk products.
• Cow's milk-specific IgE level at screening ≥10 kU/L
• Positive Skin Prick Test (SPT) to cow's milk with a largest wheal diameter ≥6 mm.
• Positive DBPCFC at screening with an eliciting dose ≤300 mg cow's milk proteins (approximately ≤9.4 mL of cow's milk).
• Negative urine pregnancy test for female subjects of childbearing potential. Female subjects of childbearing potential must agree and commit to use effective medical methods of contraception for the entire duration of their participation in the study. Sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
• Ability to perform spirometry procedures in accordance with the American Thoracic Society guidelines (2005) for subjects ≥6 years old. Ability to perform peak expiratory flow (PEF) measurements for subjects ≥5 years old. Subjects \<8 years of age who have documented inability to adequately perform spirometry can perform only the PEF evaluation. Subjects \<5 years of age may be enrolled if they had no clinical features of moderate or severe persistent asthma severity (as defined by the 2007 National Heart, Lung, and Blood Institute \[NHLBI\] Guidelines) within 1 year before Visit 1.
• Subjects and/or parents/guardians willing to comply with all study requirements during participation in the study.

You may not qualify if:

• History of severe anaphylaxis to cow's milk resulting in hypotension, hypoxia or neurological compromise (collapse, loss of consciousness or incontinence) or requiring mechanical ventilation.
• Pregnancy or lactation.
• Spirometry forced expiratory volume in 1 second (FEV1) \<80% of the predicted value at Visit 1 for subjects ≥6 years and able to perform the spirometry, or PEF \<80% of predicted value at Visit 1 for subjects performing only the PEF measurements.
• Any clinical features of moderate or severe persistent asthma severity (as defined by the 2007 NHLBI guidelines) and high daily doses of inhaled corticosteroids.
• Known allergy to the Viaskin patch materials or excipients, or to any of the components of the food challenge formulas other than the cow's milk proteins.
• Allergy or known history of reaction to Tegaderm® medical dressing with no possibility to use an alternative adhesive dressing authorized by the sponsor in replacement.
• Subjects having objective symptoms to the placebo formula leading to stopping the challenge during the screening DBPCFC.
• Severe reaction during the screening DBPCFC defined as need for intubation, and/or hypotension persisting after epinephrine administration, and/or the need for \>2 doses of epinephrine.
• Symptomatic allergy to pollens with symptoms during the pollen season that might interfere with the symptoms observed during the DBPCFC, if the DBPCFC is performed during the pollen season. Screening of such subjects should be made out of the pollen season.
• Inability to discontinue short-acting antihistamines for 3 days or long-acting antihistamines for 5 to 7 days (depending on the half-life) before the DBPCFC.
• Use of systemic long-acting corticosteroids within 12 weeks before Visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks before Visit 1 or use of systemic long-acting or short-acting corticosteroids during screening (unless used to treat symptoms triggered by the DBPCFC or triggered by accidental allergen consumption; in the latter case DBPCFC must then be scheduled after a minimum of 7 wash-out days).
• Subjects with asthma conditions meeting 1 or several criteria below:
• Uncontrolled persistent asthma (as defined by the 2007 NHLBI guidelines) or subject being treated with a combination therapy of medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2-agonist. Intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are permitted.
• At least 2 systemic corticosteroid courses for asthma within 1 year before Visit 1 or 1 oral corticosteroid course for asthma within 3 months before Visit 1, or during screening (unless used to treat symptoms triggered by the DBPCFC).
• Prior intubation/mechanical ventilation due to asthma within 2 years before Visit 1, or during screening.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (17)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

ASTHMA, Inc.

Seattle, Washington, 98115, United States

Location

Cheema Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1G6C6, Canada

Location

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, M4V 1R2, Canada

Location

Centre Hospitalier Universitaire Sainte Justine

Montreal, Quebec, H3T 1C4, Canada

Location

Clinique Spécialisée en allergie de la Capitale

Québec, G1V 4W2, Canada

Location

Related Publications (1)

• Petroni D, Begin P, Bird JA, Brown-Whitehorn T, Chong HJ, Fleischer DM, Gagnon R, Jones SM, Leonard S, Makhija MM, Oriel RC, Shreffler WG, Sindher SB, Sussman GL, Yang WH, Bee KJ, Bois T, Campbell DE, Green TD, Rutault K, Sampson HA, Wood RA. Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow's Milk Allergy: A Randomized Clinical Trial. JAMA Pediatr. 2024 Apr 1;178(4):345-353. doi: 10.1001/jamapediatrics.2023.6630.

  PMID: 38407859 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pharis Mohideen, MD Chief Medical Officer
• Organization: DBV Technologies

clinicaltrials@dbv-technologies.com

908-679-5200

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: November 1, 2014
• Primary Completion: December 14, 2017
• Study Completion: December 22, 2020
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Locations

US (12); CA (5)