Trial Outcomes & Findings for Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) (NCT NCT02635776)

Last Updated: 2022-03-17

Results Overview

The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

555 participants

Primary outcome timeframe

12 months

Results posted on

2022-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	AR101 AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.	Placebo A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
Overall Study STARTED	416	139
Overall Study COMPLETED	314	128
Overall Study NOT COMPLETED	102	11

Reasons for withdrawal

Reasons for withdrawal
Measure	AR101 AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.	Placebo A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.
Overall Study Physician Decision	1	0
Overall Study Adverse Event	51	3
Overall Study Withdrawal by Subject	41	7
Overall Study Lost to Follow-up	4	0
Overall Study Other reasons	5	1

Baseline Characteristics

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AR101 n=413 Participants AR101 drug product provided in two presentations. These were peanut protein in pull-apart capsules or sachets. Pull-apart capsules contained 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets contained 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.	Placebo n=138 Participants A Placebo matching the AR101 drug product was supplied in two presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase.	Total n=551 Participants Total of all reporting groups
Age, Customized Age customized categorical · Children (4-11 years)	238 Participants n=5 Participants	89 Participants n=7 Participants	327 Participants n=5 Participants
Age, Customized Age customized categorical · Adolescents (12-17 years)	134 Participants n=5 Participants	35 Participants n=7 Participants	169 Participants n=5 Participants
Age, Customized Age customized categorical · Adults (18-55 years)	41 Participants n=5 Participants	14 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants	56 Participants n=7 Participants	236 Participants n=5 Participants
Sex: Female, Male Male	233 Participants n=5 Participants	82 Participants n=7 Participants	315 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	17 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	383 Participants n=5 Participants	121 Participants n=7 Participants	504 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	44 Participants n=5 Participants	10 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	329 Participants n=5 Participants	109 Participants n=7 Participants	438 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	16 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	AR101 n=372 Participants Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol	Placebo n=124 Participants Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 600 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)	250 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	AR101 n=372 Participants Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol	Placebo n=124 Participants Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 1000 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)	187 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	AR101 n=372 Participants Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol	Placebo n=124 Participants Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol
Percentage of Subjects Ages 4-17 Who Tolerated a Single Highest Dose of at Least 300 mg in the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)	285 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 months

The maximum severity of symptoms on 4 levels: 0-None, 1-Mild, 2-Moderate, 3-Severe or higher (Severe, life threatening, fatal) observed in the DBPCFC at any dose (1000 mg or lower).

Outcome measures

Outcome measures
Measure	AR101 n=372 Participants Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol	Placebo n=124 Participants Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) None	140 Participants	3 Participants
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) Mild	119 Participants	35 Participants
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) Moderate	94 Participants	73 Participants
Percentage of Subjects Ages 4-17 by Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein During the Exit Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) Severe or worse	19 Participants	13 Participants

Adverse Events

AR101 (Age 4-17)

Serious events: 8 serious events

Other events: 367 other events

Deaths: 0 deaths

Placebo (Age 4-17)

Serious events: 1 serious events

Other events: 118 other events

Deaths: 0 deaths

AR101 (Age 18-55)

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo (Age 18-55)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AR101 (Age 4-17) n=372 participants at risk Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol.	Placebo (Age 4-17) n=124 participants at risk Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients. Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol.	AR101 (Age 18-55) n=41 participants at risk Study product provided as peanut protein in pull-apart capsules or sachets. AR101 powder provided in capsules \& sachets: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol.	Placebo (Age 18-55) n=14 participants at risk Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients. Placebo powder provided in capsules \& sachets: Study product formulated to contain only inactive ingredients for use as defined in the protocol.
Immune system disorders Anaphylactic reaction	0.81% 3/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	2.4% 1/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Infections and infestations Gastroenteritis	0.27% 1/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Infections and infestations Gastroenteritis viral	0.27% 1/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Infections and infestations Pharyngitis streptococcal	0.27% 1/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Injury, poisoning and procedural complications Concussion	0.27% 1/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Injury, poisoning and procedural complications Humerous fracture	0.00% 0/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.81% 1/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Nervous system disorders Syncope	0.00% 0/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	2.4% 1/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Respiratory, thoracic and mediastinal disorders Asthma	0.54% 2/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/372 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/124 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	0.00% 0/41 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).	7.1% 1/14 • 12 months The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).

Other adverse events

Additional Information

Director of Regulatory Affairs

Aimmune Therapeutics, Inc.

Phone: 650-409-5164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee * Institutions cannot publish until the multi-center sponsor publication is published * Or, institutions cannot publish until 18 months after study completion * And Sponsor review of any publications is required prior to any institution publications according to contractual agreements
Publication restrictions are in place

Restriction type: OTHER