Trial Outcomes & Findings for Peanut Epicutaneous Phase II Immunotherapy Clinical Trial (NCT NCT01904604)

NCT ID: NCT01904604

Last Updated: 2019-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Week 52

Results posted on

2019-07-01

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 milestones

Participant milestones
Measure	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). Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.	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). Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.	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). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Overall Study STARTED	25	25	25
Overall Study Completed Week 52 OFC	22	21	25
Overall Study Began Crossover Treatment	20	21	0
Overall Study Completed Week 130 OFC	18	18	23
Overall Study COMPLETED	18	18	23
Overall Study NOT COMPLETED	7	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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). Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.	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). Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.	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). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Overall Study Withdrew before receiving dosing	0	1	0
Overall Study Non-compliance	1	0	0
Overall Study Anxiety about OFC/Refused OFC	2	0	0
Overall Study Patch site reactions	1	1	0
Overall Study Increased syncope	0	1	0
Overall Study Unrelated illness	0	1	0
Overall Study Passed Week 52 OFC	1	0	0
Overall Study Withdrawal by Subject	1	2	0
Overall Study Participant Relocated	1	1	1
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Patch n=25 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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 n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=99 Participants	24 Participants n=107 Participants	25 Participants n=206 Participants	73 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	10.1 years STANDARD_DEVIATION 3.9 • n=99 Participants	9.7 years STANDARD_DEVIATION 3.4 • n=107 Participants	8.8 years STANDARD_DEVIATION 3.4 • n=206 Participants	9.5 years STANDARD_DEVIATION 3.6 • n=7 Participants
Sex: Female, Male Female	9 Participants n=99 Participants	10 Participants n=107 Participants	9 Participants n=206 Participants	28 Participants n=7 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	14 Participants n=107 Participants	16 Participants n=206 Participants	46 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	4 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=99 Participants	24 Participants n=107 Participants	22 Participants n=206 Participants	70 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) White	22 Participants n=99 Participants	18 Participants n=107 Participants	23 Participants n=206 Participants	63 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	4 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	25 participants n=99 Participants	24 participants n=107 Participants	25 participants n=206 Participants	74 participants n=7 Participants
Atopic Dermatitis Total Score	1.9 Scores on a scale STANDARD_DEVIATION 2.6 • n=99 Participants	1.4 Scores on a scale STANDARD_DEVIATION 2.3 • n=107 Participants	1.5 Scores on a scale STANDARD_DEVIATION 2.2 • n=206 Participants	1.6 Scores on a scale STANDARD_DEVIATION 2.4 • n=7 Participants
Total IgE	751.8 kU/L STANDARD_DEVIATION 797.6 • n=99 Participants	949.1 kU/L STANDARD_DEVIATION 1183.5 • n=107 Participants	691.5 kU/L STANDARD_DEVIATION 602.3 • n=206 Participants	795.4 kU/L STANDARD_DEVIATION 884.2 • n=7 Participants
Peanut IgE	77.3 kUA/L STANDARD_DEVIATION 69.4 • n=99 Participants	87.6 kUA/L STANDARD_DEVIATION 65.3 • n=107 Participants	89.9 kUA/L STANDARD_DEVIATION 64.3 • n=206 Participants	84.9 kUA/L STANDARD_DEVIATION 65.7 • n=7 Participants
Skin Prick Test Score	14.1 mm STANDARD_DEVIATION 8.6 • n=99 Participants	12.9 mm STANDARD_DEVIATION 6.8 • n=107 Participants	12.7 mm STANDARD_DEVIATION 5.2 • n=206 Participants	13.3 mm STANDARD_DEVIATION 7.0 • n=7 Participants
Age at Initial Peanut Allergic Reaction	1.9 years STANDARD_DEVIATION 1.2 • n=99 Participants	2.8 years STANDARD_DEVIATION 3.3 • n=107 Participants	2.1 years STANDARD_DEVIATION 2.0 • n=206 Participants	2.3 years STANDARD_DEVIATION 2.3 • n=7 Participants

PRIMARY outcome

Timeframe: Week 52

Population: All randomized subjects who received study treatment.

Outcome measures

Outcome measures
Measure	Placebo Patch n=25 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
Percentage of Subjects With a Successful Treatment Response	12.0 percentage of participants	45.8 percentage of participants	48.0 percentage of participants

SECONDARY outcome

Timeframe: Week 130 (Month 30)

Population: 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.

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)

Outcome measures

Outcome measures
Measure	Placebo Patch n=20 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
Percentage of Subjects Desensitized to Peanut Protein	5.0 percentage of participants Interval 0.1 to 24.9	20.8 percentage of participants Interval 7.1 to 42.2	36.0 percentage of participants Interval 18.0 to 57.5

SECONDARY outcome

Timeframe: Week 130 (Month 30)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Patch n=20 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein SCD>=1044 mg peanut protein	10.0 percentage of participants Interval 1.2 to 31.7	16.7 percentage of participants Interval 4.7 to 37.4	32.0 percentage of participants Interval 14.9 to 53.5
Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein SCD=5044 mg peanut protein	0.0 percentage of participants Interval 0.0 to 16.8	0.0 percentage of participants Interval 0.0 to 14.2	0.0 percentage of participants Interval 0.0 to 13.7

SECONDARY outcome

Timeframe: Week 52

Population: All randomized subjects who received active (not placebo) study treatment.

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

Outcome measures

Outcome measures
Measure	Placebo Patch n=24 Participants 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.	100 µg Peanut Patch n=25 Participants 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.	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). High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	12.5 percentage of participants	20.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized subjects who completed the Week 52 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.

Outcome measures

Outcome measures
Measure	Placebo Patch n=22 Participants 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.	100 µg Peanut Patch n=21 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	14 mg protein Interval 1.0 to 5044.0	144 mg protein Interval 44.0 to 2044.0	144 mg protein Interval 0.0 to 2044.0

SECONDARY outcome

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

Population: None of the participants passed the Week 130 OFC so this could not be assessed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 52 and Month 30 (Week 130)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Patch n=25 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months Had AE related to study therapy through Week 52	88.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months Had AE related to study therapy through Month 30	100.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: Month 30 (Week 130)

Population: All randomized subjects who received active (not placebo) study treatment. The Placebo Patch group includes the 20 subjects who crossed over to active treatment.

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

Outcome measures

Outcome measures
Measure	Placebo Patch n=20 Participants 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.	100 µg Peanut Patch n=24 Participants 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.	250 µg Peanut Patch n=25 Participants 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.
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	65.0 percentage of participants	62.5 percentage of participants	64.0 percentage of participants

Adverse Events

Placebo Patch Before Week 52 OFC (Double Blind)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

100 µg Peanut Patch

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

250 µg Peanut Patch

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Patch Before Week 52 OFC (Double Blind) n=25 participants at risk 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.	Placebo Patch Crossed Over to 250 µg Peanut Patch (Open Label) n=20 participants at risk 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.	100 µg Peanut Patch n=24 participants at risk 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.	250 µg Peanut Patch n=25 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	4.0% 1/25 • Number of events 1 • 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. 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.	0.00% 0/20 • 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. 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.	0.00% 0/24 • 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. 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.	0.00% 0/25 • 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. 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.
Nervous system disorders Syncope	0.00% 0/25 • 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. 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.	0.00% 0/20 • 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. 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.	4.2% 1/24 • Number of events 1 • 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. 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.	0.00% 0/25 • 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. 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.
Nervous system disorders Migraine	0.00% 0/25 • 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. 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.	0.00% 0/20 • 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. 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.	4.2% 1/24 • Number of events 1 • 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. 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.	0.00% 0/25 • 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. 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.

Other adverse events

Additional Information

Director, Clinical Research Program

DAIT/NIAID

Phone: (301) 594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place