Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children

NCT01955109 | Completed Phase 2 Results DMC

• 2 other identifiers: OLFUS-VIPES2013-001754-10
• Study Type: interventional
• Target: 171
• Locations: 4 countries
• Sites: 22

Brief Summary

The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are:

• To assess the efficacy of Viaskin Peanut after up to 36 months of treatment.
• To evaluate the safety of long-term treatment with Viaskin Peanut.
• To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

Conditions

Peanut Allergy

Keywords

Food allergy; Immediate hypersensitivity; Whole peanut extract; Allergenic product; Specific Immunotherapy; Epicutaneous Immunotherapy (EPIT)

Outcome Measures

Primary Outcomes (1)

• Percentage of Treatment Responders at Months 12 and 24

  A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.

  Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study

Secondary Outcomes (7)

• Percentage of Participants Unresponsive to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 24

  Month 24 (end of treatment) of the OLFUS-VIPES study

• Percentage of Participants With a Sustained Unresponsiveness to a Cumulative Dose of at Least 1440 mg Peanut Protein at Month 26

  Month 26 (2 months post-treatment) of the OLFUS-VIPES study

• Median Cumulative Reactive Dose of Peanut Protein at Months 12 and 24

  Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study

• Mean Cumulative Reactive Dose of Peanut Protein at Months 12 and 24

  Month 12 and Month 24 (end of treatment) of the OLFUS-VIPES study

• Change From VIPES Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 6, 12, 18 and 24

  VIPES Baseline to Months 6, 12, 18 and 24 (end of treatment) of the OLFUS-VIPES study

Study Arms (1)

Viaskin Peanut 250 mcg

EXPERIMENTAL

Biological: Viaskin Peanut 250 mcg

Interventions

Viaskin Peanut 250 mcg BIOLOGICAL

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract

Viaskin Peanut 250 mcg

Eligibility Criteria

• Age: 7 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult and pediatric subjects (≥7 years) who completed the VIPES study, with a mandatory and documented DBPCFC at Month 12 in the VIPES study.
• Signed informed consent from adult subjects or parent(s)/guardian(s) of children \<18 years and children's assent for children \>7 years or as per country-specific regulations or laws. This consent should be signed no later than Visit 11 in the VIPES study.
• Negative pregnancy test for women of childbearing potential at Visit 10 in the VIPES study.
• Female subject of childbearing potential must use effective methods of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study. Documented sexual abstinence will be accepted as an effective method of contraception for girls below 15 years of age.
• Subjects and/or parents/guardians willing to comply with all study requirements during their participation in the study.

You may not qualify if:

• Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine.
• Pregnancy or lactation.
• Females of childbearing potential planning a pregnancy in the coming 2 to 3 years.
• Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore.
• Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study.
• Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges.
• Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows:
• uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled β2-agonists.
• 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 year.
• Subjects receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
• Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
• Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study.
• Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study.
• Allergy or known history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor.

Sponsors & Collaborators

• DBV Technologies: lead

Study Sites (22)

University of California, Rady Childrens Hospital

San Diego, California, 92123, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Childrens' Hospital

Boston, Massachusetts, 02115, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Medical Center 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 Asthma Research Institute

Ottawa, Ontario, K1Y 4G2, Canada

Location

Gordon Sussman Clinical Research

Toronto, Ontario, M4V 1R2, Canada

Location

Centre de Recherche Appliquée en Asthme et Allergie de Québec

Sainte-Foy, Quebec, G1V 4M6, Canada

Location

Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

GCS des hôpitaux pédiatriques

Nice, 06200, France

Location

Hôpital Necker

Paris, 75743, France

Location

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Hôpitaux De Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10. No abstract available.

  PMID: 30978404 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: DBV Technologies

clinicaltrials@dbv-technologies.com

33-1-55-42-78-78

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 7, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2022

Record last verified: 2022-06

Locations

FR (6); CA (4); US (10); NL (2)