CClinicalTrials.gg
Sign In
CompletedNCT01904604Updated Jul 1, 2019Results posted

Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

A Phase 2 interventional study of Placebo Viaskin® Patch and Low-dose DBV712 Viaskin® Patch in Peanut Hypersensitivity, Food Hypersensitivity and Hypersensitivity, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 5 sites in United States. Open to participants aged 4 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-07-01.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
4 Years to 25 Years
Sex
All
01

Study summary

Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.

Read the detailed description

This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.

02

Conditions studied

  • Peanut Hypersensitivity
  • Food Hypersensitivity
  • Hypersensitivity
  • Hypersensitivity, Immediate

Keywords

  • Peanut Allergy
  • Food Allergy
  • Viaskin peanut patch
  • Allergen Immunotherapy
  • Epicutaneous Immunotherapy
  • Whole peanut extract
  • Allergenic product
  • Immediate hypersensitivity
03

Who can participate

Ages eligible
4 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BiologicalPlacebo Viaskin® Patch

    Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.

  • BiologicalLow-dose DBV712 Viaskin® Patch

    100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

  • BiologicalHigh-dose DBV712 Viaskin® Patch

    250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

05

What researchers measure

Primary outcomes

  1. Percentage of Subjects With a Successful Treatment Response

    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.

    Time frame: Week 52

Secondary outcomes

  1. Percentage of Subjects Desensitized to Peanut Protein

    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)

    Time frame: Week 130 (Month 30)

  2. Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein

    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.

    Time frame: Week 130 (Month 30)

  3. Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)

    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

    Time frame: Week 52

  4. Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)

    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.

    Time frame: Week 52

  5. 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)

    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.

    Time frame: 8 and 20 weeks after the Week 130 (Month 30) OFC

  6. Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months

    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.

    Time frame: Week 52 and Month 30 (Week 130)

  7. 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

    Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.

    Time frame: Month 30 (Week 130)

06

Results

Posted Aug 26, 2016

Participant flow

Recruitment took place from September 2013 to July 2014 at the five listed university-based medical centers located in the United States.

Participant flow — Overall Study
MilestonePlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Started252525
Completed week 52 ofc222125
Began crossover treatment20210
Completed week 130 ofc181823
Completed181823
Not completed772
Withdrew: Withdrew before receiving dosing010
Withdrew: Non-compliance100
Withdrew: Anxiety about ofc/refused ofc200
Withdrew: Patch site reactions110
Withdrew: Increased syncope010
Withdrew: Unrelated illness010
Withdrew: Passed week 52 ofc100
Withdrew: Withdrawal by subject120
Withdrew: Participant relocated111
Withdrew: Lost to follow-up001

Outcome measures

PrimaryPercentage of Subjects With a Successful Treatment Response

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.

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Subjects With a Successful Treatment Response
percentage of participantsPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Percentage of Subjects With a Successful Treatment Response12.045.848.0
Statistical analysis
  • Placebo Patch vs 100 µg Peanut Patch · Barnard's statistic · p = 0.005 (A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.) · Risk difference (rd): 33.8 · 33.8% CI 10.2 to 57.5
  • Placebo Patch vs 250 µg Peanut Patch · Barnard's statistic · p = 0.003 (A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.) · Risk difference (rd): 36.0 · 36.0% CI 12.6 to 59.4
  • 100 µg Peanut Patch vs 250 µg Peanut Patch · Barnard's statistic · p = 0.48 (A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.) · Risk difference (rd): 2.2 · 2.2% CI -25.8 to 30.1
SecondaryPercentage of Subjects Desensitized to Peanut Protein

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)

Time frame:
Week 130 (Month 30)
Reported as:
Number · percentage of participants
Percentage of Subjects Desensitized to Peanut Protein
percentage of participantsPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Percentage of Subjects Desensitized to Peanut Protein5.0 (0.1 to 24.9)20.8 (7.1 to 42.2)36.0 (18.0 to 57.5)
SecondaryPercentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein

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.

Time frame:
Week 130 (Month 30)
Reported as:
Number · percentage of participants
Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein
percentage of participantsPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
SCD>=1044 mg peanut protein10.0 (1.2 to 31.7)16.7 (4.7 to 37.4)32.0 (14.9 to 53.5)
SCD=5044 mg peanut protein0.0 (0.0 to 16.8)0.0 (0.0 to 14.2)0.0 (0.0 to 13.7)
SecondaryPercentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)

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

Time frame:
Week 52
Reported as:
Number · percentage of participants
Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
percentage of participants100 µg Peanut Patch250 µg Peanut Patch
Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)12.520.0
SecondaryAverage Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)

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.

Time frame:
Week 52
Reported as:
Median · mg protein
Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
mg proteinPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)14 (1 to 5044)144 (44 to 2044)144 (0 to 2044)
Statistical analysis
  • 100 µg Peanut Patch vs 250 µg Peanut Patch · Wilcoxon (Mann-Whitney) · p = 0.80 (No adjustments were made to the p-value.)The two-sided t approximation was used.
  • Placebo Patch vs 100 µg Peanut Patch · Wilcoxon (Mann-Whitney) · p = 0.008 (No adjustments were made to the p-value.)The two-sided t approximation was used.
  • Placebo Patch vs 250 µg Peanut Patch · Wilcoxon (Mann-Whitney) · p = 0.01 (No adjustments were made to the p-value.)The two-sided t approximation was used.
SecondaryPercentage 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)

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.

Time frame:
8 and 20 weeks after the Week 130 (Month 30) OFC

No measurements were reported for this outcome.

SecondaryPercentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months

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.

Time frame:
Week 52 and Month 30 (Week 130)
Reported as:
Number · percentage of participants
Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months
percentage of participantsPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Had AE related to study therapy through Week 5288.0100.0100.0
Had AE related to study therapy through Month 30100.0100.0100.0
SecondaryPercentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy

Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.

Time frame:
Month 30 (Week 130)
Reported as:
Number · percentage of participants
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
percentage of participantsPlacebo Patch100 µg Peanut Patch250 µg Peanut Patch
Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy65.062.564.0

Adverse events

Collected over For the Placebo Patch group, data were collected for 52 weeks of double-blind dosing with a placebo patch and 130 weeks of open label dosing on active treatment with the DBV712 Viaskin® Patch with 250 µg peanut protein. For the 100 µg Peanut Patch group and the 250 µg Peanut Patch group, data were collected for 52 weeks of double-blind dosing and then 78 weeks of open label dosing for a total of 130 weeks of active treatment.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Patch Before Week 52 OFC (Double Blind)0/25 (0%)1/25 (4%)23/25 (92%)
Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)0/20 (0%)0/20 (0%)20/20 (100%)
100 µg Peanut Patch0/24 (0%)2/24 (8.3%)24/24 (100%)
250 µg Peanut Patch0/25 (0%)0/25 (0%)25/25 (100%)
Most frequent serious events
Most frequent serious events
EventPlacebo Patch Before Week 52 OFC (Double Blind)Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)100 µg Peanut Patch250 µg Peanut Patch
SyncopeNervous system disorders0/250/201/240/25
MigraineNervous system disorders0/250/201/240/25
Abdominal PainGastrointestinal disorders1/250/200/240/25
Most frequent other events
Showing 10 of 48
Most frequent other events
EventPlacebo Patch Before Week 52 OFC (Double Blind)Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)100 µg Peanut Patch250 µg Peanut Patch
Application site erythemaGeneral disorders19/2520/2024/2425/25
Application site extravasationGeneral disorders8/2519/2022/2425/25
Application site papulesGeneral disorders6/2516/2023/2425/25
Application site pruritusGeneral disorders18/2520/2024/2425/25
Upper respiratory tract infectionInfections and infestations5/257/2011/2415/25
PyrexiaGeneral disorders5/254/206/248/25
SinusitisInfections and infestations0/252/201/248/25
Pharyngitis streptococcalInfections and infestations2/252/203/247/25
Viral infectionInfections and infestations1/252/203/247/25
Viral upper respiratory tract infectionInfections and infestations3/255/205/247/25

Baseline characteristics

All randomized subjects who received study treatment. Note that 1 subject in the 100 µg Peanut Patch group who never received treatment was not included.

Age, Categorical
Age, Categorical(Participants)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
<=18 years24242573
Between 18 and 65 years1001
>=65 years0000
Age, Continuous
Age, Continuous(years)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
Mean10.1 ± 3.99.7 ± 3.48.8 ± 3.49.5 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
Female910928
Male16141646
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
Hispanic or Latino1034
Not Hispanic or Latino24242270
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
American Indian or Alaska Native0000
Asian1102
Native Hawaiian or Other Pacific Islander0000
Black or African American2103
White22182363
More than one race0426
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
United States25242574
Atopic Dermatitis Total Score
Atopic Dermatitis Total Score(Scores on a scale)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
Mean1.9 ± 2.61.4 ± 2.31.5 ± 2.21.6 ± 2.4
Total IgE
Total IgE(kU/L)Placebo Patch100 µg Peanut Patch250 µg Peanut PatchTotal
Mean751.8 ± 797.6949.1 ± 1183.5691.5 ± 602.3795.4 ± 884.2

3 further baseline measures are reported on the registry.

07

Study locations

5 sites
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202, United States
  • National Jewish Health
    Denver, Colorado 80206, United States
  • The Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • University of North Carolina at Chapel Hill School of Medicine
    Chapel Hill, North Carolina 27599, United States
08

References and documents

Publications

  • Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1. PubMed 24789880 ↗
  • Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26. PubMed 28091362 ↗
  • Scurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5. PubMed 33290772 ↗
  • Chiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31. PubMed 29408715 ↗

Individual participant data

Plan to share: Yes — 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.

09

Registry details

Key details

Study ID
NCT01904604
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Consortium of Food Allergy Research
Responsible party
Sponsor
First posted
Jul 22, 2013
Start date
Sep 2013
Primary completion
Aug 2015
Completion
Aug 21, 2018
Results posted
Aug 26, 2016
Last update
Jul 1, 2019

Study contacts

Stacie M. Jones, MD
study chair · University of Arkansas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypersensitivity→

Other studies from this sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Start the discussion