Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01904604|
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : August 26, 2016
Last Update Posted : July 1, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate||Biological: Placebo Viaskin® Patch Biological: Low-dose DBV712 Viaskin® Patch Biological: High-dose DBV712 Viaskin® Patch||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 21, 2018|
Placebo Comparator: Placebo Patch
Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Biological: Placebo Viaskin® Patch
Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
Experimental: 100 µg Peanut Patch
Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Biological: Low-dose DBV712 Viaskin® Patch
100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Experimental: 250 µg Peanut Patch
Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
Biological: High-dose DBV712 Viaskin® Patch
250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
- Percentage of Subjects With a Successful Treatment Response [ Time Frame: Week 52 ]Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.
- Percentage of Subjects Desensitized to Peanut Protein [ Time Frame: Week 130 (Month 30) ]
Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:
1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.
BL=Baseline, Wk 130=Week 130 (Month 30)
- Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein [ Time Frame: Week 130 (Month 30) ]Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein.
- Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) [ Time Frame: Week 52 ]
Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:
0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.
BL=Baseline, Wk 52=Week 52
- Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) [ Time Frame: Week 52 ]The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.
- Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC) [ Time Frame: 8 and 20 weeks after the Week 130 (Month 30) OFC ]Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.
- Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months [ Time Frame: Week 52 and Month 30 (Week 130) ]Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.
- Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy [ Time Frame: Month 30 (Week 130) ]Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||4 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Physician-diagnosed peanut allergy OR convincing history of peanut allergy
- A skin prick test positive to peanut (wheal diameter ≥3mm greater than the saline control) OR detectable peanut specific Immunoglobulin E (IgE) (ImmunoCAP >0.35 kUA/L)
- Positive reaction to a cumulative dose of ≤1044 mg peanut protein in the initial qualifying Oral Food Challenge (OFC)
- Use of 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
- Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994). Children ages 4-11 years who have documented inability to adequately perform spirometry may be enrolled if Peak Expiratory Flow (PEF) is >80% of predicted
- Provide signed informed consent or assent where indicated
- History of anaphylaxis to peanut resulting in hypotension, neurological compromise or requiring mechanical ventilation
- Participation in a study using an investigational new drug in the last 30 days
- Participation in any interventional study for the treatment of food allergy in the past 6 months
- Pregnancy or lactation
- Current or known allergy to the Viaskin Peanut/Placebo patch device or excipients
- Current or known allergy to the placebo allergen (oat flour) in oral food challenge (OFC)
- Currently in a build-up phase of any allergen immunotherapy
- Severe or poorly controlled atopic dermatitis or greater than a mild flare of active disease at enrollment
- Forced Expiratory Volume in 1 Second (FEV1) value <80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (>500mcg of Fluticasone or equivalent)
- Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst or steroid course in the past 3 months, or >1 burst oral steroid course in the past year or use of oral or parenteral steroids for a non-asthma indication within the past 30 days
- Asthma requiring >1 hospitalization in the past year for asthma or >1 Emergency Department (ED) visit in the past 6 months for asthma
- Any previous intubation/mechanical ventilation due to allergies or asthma
- Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory or biologic therapy in the past year
- Use of beta-adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers in the past 30 days
- Inability to discontinue antihistamines for skin testing and OFC
- History of alcohol or drug abuse
- History of cardiovascular disease, uncontrolled hypertension, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or other medical conditions including immunologic disorders or HIV infection which, in the opinion of the investigator, make the subject unsuitable for treatment or at increased risk of anaphylaxis or poor outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904604
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, Maryland|
|The Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, North Carolina|
|University of North Carolina at Chapel Hill School of Medicine|
|Chapel Hill, North Carolina, United States, 27599|
|Study Chair:||Stacie M. Jones, MD||University of Arkansas|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
5U19AI066738-07 ( U.S. NIH Grant/Contract )
|First Posted:||July 22, 2013 Key Record Dates|
|Results First Posted:||August 26, 2016|
|Last Update Posted:||July 1, 2019|
|Last Verified:||June 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The plan is to share data in ImmPort [https://immport.niaid.nih.gov/ ], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.|
|Time Frame:||After completion of the trial.|
|Access Criteria:||After completion of the trial.|
Viaskin peanut patch
Whole peanut extract
Immune System Diseases
Nut and Peanut Hypersensitivity