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Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904604
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : August 26, 2016
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Interventions Biological: Placebo Viaskin® Patch
Biological: Low-dose DBV712 Viaskin® Patch
Biological: High-dose DBV712 Viaskin® Patch
Enrollment 75
Recruitment Details Recruitment took place from September 2013 to July 2014 at the five listed university-based medical centers located in the United States.
Pre-assignment Details  
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Period Title: Overall Study
Started 25 25 25
Completed Week 52 OFC [1] 22 21 25
Began Crossover Treatment 20 [2] 21 0 [3]
Completed Week 130 OFC 18 18 23
Completed 18 [4] 18 [4] 23 [4]
Not Completed 7 7 2
Reason Not Completed
Withdrew before receiving dosing             0             1             0
Non-compliance             1             0             0
Anxiety about OFC/Refused OFC             2             0             0
Patch site reactions             1             1             0
Increased syncope             0             1             0
Unrelated illness             0             1             0
Passed Week 52 OFC             1             0             0
Withdrawal by Subject             1             2             0
Participant Relocated             1             1             1
Lost to Follow-up             0             0             1
[1]
Completion of the Week 52 OFC was required to assess the primary endpoint of the study.
[2]
2 participants who completed the Week 52 OFC did not crossover; 1 passed the OFC and 1 relocated.
[3]
Per protocol, this treatment group did not crossover.
[4]
COMPLETED: Completed the Week 130 Oral Food Challenge (OFC).
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch Total
Hide Arm/Group Description

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Total of all reporting groups
Overall Number of Baseline Participants 25 24 25 74
Hide Baseline Analysis Population Description
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 25 participants 74 participants
<=18 years
24
  96.0%
24
 100.0%
25
 100.0%
73
  98.6%
Between 18 and 65 years
1
   4.0%
0
   0.0%
0
   0.0%
1
   1.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 25 participants 74 participants
10.1  (3.9) 9.7  (3.4) 8.8  (3.4) 9.5  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 25 participants 74 participants
Female
9
  36.0%
10
  41.7%
9
  36.0%
28
  37.8%
Male
16
  64.0%
14
  58.3%
16
  64.0%
46
  62.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 25 participants 74 participants
Hispanic or Latino
1
   4.0%
0
   0.0%
3
  12.0%
4
   5.4%
Not Hispanic or Latino
24
  96.0%
24
 100.0%
22
  88.0%
70
  94.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 25 participants 74 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
1
   4.2%
0
   0.0%
2
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   8.0%
1
   4.2%
0
   0.0%
3
   4.1%
White
22
  88.0%
18
  75.0%
23
  92.0%
63
  85.1%
More than one race
0
   0.0%
4
  16.7%
2
   8.0%
6
   8.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 24 participants 25 participants 74 participants
25 24 25 74
Atopic Dermatitis Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 25 participants 24 participants 25 participants 74 participants
1.9  (2.6) 1.4  (2.3) 1.5  (2.2) 1.6  (2.4)
[1]
Measure Description: The Atopic Dermatitis Total Score is scored on a 10 point scale of 0 to 9 where a higher score indicates increasing severity of atopic dermatitis. This score is a combination of three scores that range from 0 to 3 in the following areas: body surface area score, disease course, and disease intensity.
Total IgE   [1] 
Mean (Standard Deviation)
Unit of measure:  kU/L
Number Analyzed 25 participants 24 participants 25 participants 74 participants
751.8  (797.6) 949.1  (1183.5) 691.5  (602.3) 795.4  (884.2)
[1]
Measure Description: Total amount of serum immunoglobulin E.
Peanut IgE   [1] 
Mean (Standard Deviation)
Unit of measure:  kUA/L
Number Analyzed 25 participants 24 participants 25 participants 74 participants
77.3  (69.4) 87.6  (65.3) 89.9  (64.3) 84.9  (65.7)
[1]
Measure Description: Amount of serum peanut-specific immunoglobulin E. Individuals with a peanut IgE of <0.35 kUA/L are considered not to be sensitized to peanut.
Skin Prick Test Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 25 participants 24 participants 25 participants 74 participants
14.1  (8.6) 12.9  (6.8) 12.7  (5.2) 13.3  (7.0)
[1]
Measure Description: This score is calculated by subtracting the size of the saline wheal (in mm) from the size of the peanut wheal (in mm) observed for a skin prick test. Individuals with a peanut skin prick test score of < 3 mm are considered to have a negative result.
Age at Initial Peanut Allergic Reaction  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 25 participants 74 participants
1.9  (1.2) 2.8  (3.3) 2.1  (2.0) 2.3  (2.3)
1.Primary Outcome
Title Percentage of Subjects With a Successful Treatment Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received study treatment.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 25 24 25
Measure Type: Number
Unit of Measure: percentage of participants
12.0 45.8 48.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Patch, 100 µg Peanut Patch
Comments The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments 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.
Method Barnard's statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 33.8
Confidence Interval (2-Sided) 33.8%
10.2 to 57.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Patch, 250 µg Peanut Patch
Comments The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments 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.
Method Barnard's statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 36.0
Confidence Interval (2-Sided) 36.0%
12.6 to 59.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 100 µg Peanut Patch, 250 µg Peanut Patch
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments 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.
Method Barnard's statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.2
Confidence Interval (2-Sided) 2.2%
-25.8 to 30.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Desensitized to Peanut Protein
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 20 24 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.0
(0.1 to 24.9)
20.8
(7.1 to 42.2)
36.0
(18.0 to 57.5)
3.Secondary Outcome
Title Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 20 24 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SCD>=1044 mg peanut protein
10.0
(1.2 to 31.7)
16.7
(4.7 to 37.4)
32.0
(14.9 to 53.5)
SCD=5044 mg peanut protein
0.0
(0.0 to 16.8)
0.0
(0.0 to 14.2)
0.0
(0.0 to 13.7)
4.Secondary Outcome
Title Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received active (not placebo) study treatment.
Arm/Group Title 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 24 25
Measure Type: Number
Unit of Measure: percentage of participants
12.5 20.0
5.Secondary Outcome
Title Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who completed the Week 52 OFC.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 22 21 25
Median (Full Range)
Unit of Measure: mg protein
14
(1 to 5044)
144
(44 to 2044)
144
(0 to 2044)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 µg Peanut Patch, 250 µg Peanut Patch
Comments The null hypothesis was that there was no difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments No adjustments were made to the p-value.
Method Wilcoxon (Mann-Whitney)
Comments The two-sided t approximation was used.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Patch, 100 µg Peanut Patch
Comments The null hypothesis was that there was no difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments No adjustments were made to the p-value.
Method Wilcoxon (Mann-Whitney)
Comments The two-sided t approximation was used.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo Patch, 250 µg Peanut Patch
Comments The null hypothesis was that there was no difference between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments No adjustments were made to the p-value.
Method Wilcoxon (Mann-Whitney)
Comments The two-sided t approximation was used.
6.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
None of the participants passed the Week 130 OFC so this could not be assessed.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received study treatment were included in the analysis. For the Placebo Patch group, at Week 130 only the 20 participants who crossed over to active treatment were included.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 25 24 25
Measure Type: Number
Unit of Measure: percentage of participants
Had AE related to study therapy through Week 52 88.0 100.0 100.0
Had AE related to study therapy through Month 30 100.0 100.0 100.0
8.Secondary Outcome
Title 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
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received active (not placebo) study treatment. The Placebo Patch group includes the 20 subjects who crossed over to active treatment.
Arm/Group Title Placebo Patch 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description:

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).

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

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Overall Number of Participants Analyzed 20 24 25
Measure Type: Number
Unit of Measure: percentage of participants
65.0 62.5 64.0
Time Frame 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.
Adverse Event Reporting Description This study graded the severity of Adverse Events experienced by participants according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.
 
Arm/Group Title Placebo Patch Before Week 52 OFC (Double Blind) Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) 100 µg Peanut Patch 250 µg Peanut Patch
Hide Arm/Group Description

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).

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

After 52 weeks of double-blind Placebo Patch therapy, 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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

All-Cause Mortality
Placebo Patch Before Week 52 OFC (Double Blind) Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) 100 µg Peanut Patch 250 µg Peanut Patch
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/20 (0.00%)      0/24 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Placebo Patch Before Week 52 OFC (Double Blind) Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) 100 µg Peanut Patch 250 µg Peanut Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/20 (0.00%)      2/24 (8.33%)      0/25 (0.00%)    
Gastrointestinal disorders         
Abdominal Pain * 1  1/25 (4.00%)  1 0/20 (0.00%)  0 0/24 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders         
Syncope * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 0/25 (0.00%)  0
Migraine * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 0/25 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Patch Before Week 52 OFC (Double Blind) Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) 100 µg Peanut Patch 250 µg Peanut Patch
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/25 (92.00%)      20/20 (100.00%)      24/24 (100.00%)      25/25 (100.00%)    
Eye disorders         
Eye pruritus  1  0/25 (0.00%)  0 2/20 (10.00%)  3 0/24 (0.00%)  0 0/25 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain upper * 1  3/25 (12.00%)  3 1/20 (5.00%)  2 0/24 (0.00%)  0 2/25 (8.00%)  2
Diarrhoea * 1  1/25 (4.00%)  1 3/20 (15.00%)  4 4/24 (16.67%)  5 2/25 (8.00%)  2
Vomiting * 1  1/25 (4.00%)  1 1/20 (5.00%)  1 3/24 (12.50%)  5 5/25 (20.00%)  8
General disorders         
Application site erythema  2  19/25 (76.00%)  1125 20/20 (100.00%)  13802 24/24 (100.00%)  12823 25/25 (100.00%)  16443
Application site extravasation  1  8/25 (32.00%)  329 19/20 (95.00%)  5335 22/24 (91.67%)  4822 25/25 (100.00%)  5066
Application site papules  1  6/25 (24.00%)  128 16/20 (80.00%)  2918 23/24 (95.83%)  2725 25/25 (100.00%)  4575
Application site pruritus  1  18/25 (72.00%)  728 20/20 (100.00%)  11580 24/24 (100.00%)  9175 25/25 (100.00%)  14214
Application site reaction * 1  2/25 (8.00%)  2 0/20 (0.00%)  0 3/24 (12.50%)  3 2/25 (8.00%)  2
Pyrexia * 1  5/25 (20.00%)  5 4/20 (20.00%)  7 6/24 (25.00%)  11 8/25 (32.00%)  11
Immune system disorders         
Allergy to animal * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 2/24 (8.33%)  3 1/25 (4.00%)  2
Seasonal allergy * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 2/24 (8.33%)  2 2/25 (8.00%)  2
Infections and infestations         
Croup infectious * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 0/24 (0.00%)  0 3/25 (12.00%)  3
Ear infection * 1  2/25 (8.00%)  4 2/20 (10.00%)  4 2/24 (8.33%)  3 1/25 (4.00%)  1
Gastoenteritis viral * 1  2/25 (8.00%)  2 2/20 (10.00%)  2 3/24 (12.50%)  3 4/25 (16.00%)  4
Gastroenteritis * 1  3/25 (12.00%)  5 1/20 (5.00%)  1 3/24 (12.50%)  3 2/25 (8.00%)  2
Influenza * 1  2/25 (8.00%)  2 2/20 (10.00%)  2 3/24 (12.50%)  3 4/25 (16.00%)  4
Otitis externa * 1  1/25 (4.00%)  1 1/20 (5.00%)  1 1/24 (4.17%)  1 2/25 (8.00%)  2
Otitis media * 1  0/25 (0.00%)  0 2/20 (10.00%)  2 1/24 (4.17%)  1 3/25 (12.00%)  3
Pharyngitis streptococcal * 1  2/25 (8.00%)  3 2/20 (10.00%)  2 3/24 (12.50%)  9 7/25 (28.00%)  12
Sinusitis * 1  0/25 (0.00%)  0 2/20 (10.00%)  2 1/24 (4.17%)  1 8/25 (32.00%)  14
Upper respiratory tract infection * 1  5/25 (20.00%)  6 7/20 (35.00%)  10 11/24 (45.83%)  21 15/25 (60.00%)  26
Viral infection * 3  1/25 (4.00%)  3 2/20 (10.00%)  3 3/24 (12.50%)  3 7/25 (28.00%)  7
Viral upper respiratory tract infection * 1  3/25 (12.00%)  5 5/20 (25.00%)  11 5/24 (20.83%)  9 7/25 (28.00%)  15
Conjunctivitis * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 1/24 (4.17%)  2 2/25 (8.00%)  2
Gastrointestinal viral infection * 1  0/25 (0.00%)  0 2/20 (10.00%)  4 1/24 (4.17%)  1 1/25 (4.00%)  1
Pharyngitis * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 1/24 (4.17%)  1 2/25 (8.00%)  2
Tonsilitis * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 2/24 (8.33%)  2 0/25 (0.00%)  0
Injury, poisoning and procedural complications         
Concussion * 1  2/25 (8.00%)  2 1/20 (5.00%)  1 2/24 (8.33%)  2 2/25 (8.00%)  2
Laceration * 1  0/25 (0.00%)  0 0/20 (0.00%)  0 0/24 (0.00%)  0 2/25 (8.00%)  2
Ligament sprain * 1  0/25 (0.00%)  0 2/20 (10.00%)  2 2/24 (8.33%)  2 0/25 (0.00%)  0
Nervous system disorders         
Headache * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 4/24 (16.67%)  12 3/25 (12.00%)  10
Migraine * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 1/24 (4.17%)  1 2/25 (8.00%)  2
Psychiatric disorders         
Anxiety * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 2/24 (8.33%)  3 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  1/25 (4.00%)  1 0/20 (0.00%)  0 6/24 (25.00%)  8 3/25 (12.00%)  4
Cough * 1  2/25 (8.00%)  2 4/20 (20.00%)  5 4/24 (16.67%)  4 4/25 (16.00%)  7
Nasal congestion * 1  3/25 (12.00%)  3 1/20 (5.00%)  1 1/24 (4.17%)  1 2/25 (8.00%)  3
Oropharyngeal pain * 1  4/25 (16.00%)  4 1/20 (5.00%)  1 1/24 (4.17%)  1 2/25 (8.00%)  2
Oropharyngeal discomfort  5  0/25 (0.00%)  0 2/20 (10.00%)  5 0/24 (0.00%)  0 0/25 (0.00%)  0
Wheezing * 1  0/25 (0.00%)  0 1/20 (5.00%)  1 2/24 (8.33%)  3 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders         
Pruritus  1  2/25 (8.00%)  5 3/20 (15.00%)  4 5/24 (20.83%)  7 2/25 (8.00%)  2
Rash * 1  2/25 (8.00%)  2 2/20 (10.00%)  2 0/24 (0.00%)  0 3/25 (12.00%)  4
Urticaria * 1  3/25 (12.00%)  4 3/20 (15.00%)  4 2/24 (8.33%)  2 0/25 (0.00%)  0
Urticaria  4  1/25 (4.00%)  11 4/20 (20.00%)  6 4/24 (16.67%)  8 4/25 (16.00%)  7
Dermatitis atopic * 1  0/25 (0.00%)  0 2/20 (10.00%)  8 1/24 (4.17%)  2 0/25 (0.00%)  0
Dermatitis contact * 1  0/25 (0.00%)  0 2/20 (10.00%)  2 1/24 (4.17%)  1 1/25 (4.00%)  1
Surgical and medical procedures         
Mole excision * 1  2/25 (8.00%)  2 0/20 (0.00%)  0 0/24 (0.00%)  0 0/25 (0.00%)  0
Vascular disorders         
Flushing  1  1/25 (4.00%)  1 0/20 (0.00%)  0 3/24 (12.50%)  3 1/25 (4.00%)  1
1
Term from vocabulary, MedDRA 20.0
2
Term from vocabulary, MedDRA 19.0
3
Term from vocabulary, MedDRA 20.1
4
Term from vocabulary, MedDRA 21.1
5
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: (301) 594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01904604    
Other Study ID Numbers: DAIT CoFAR6
5U19AI066738-07 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2013
First Posted: July 22, 2013
Results First Submitted: July 15, 2016
Results First Posted: August 26, 2016
Last Update Posted: July 1, 2019