Trial Outcomes & Findings for Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT (NCT NCT01987817)
NCT ID: NCT01987817
Last Updated: 2021-11-30
Results Overview
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
6-9 Months
Results posted on
2021-11-30
Participant Flow
A total of 67 subjects signed the informed consent and went through the screening process. 11 subjects failed screening, resulting in 56 subjects being enrolled and initially randomized. The randomized population comprised 29 subjects in the AR101 group and 27 subjects in the placebo group. The final intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) had one fewer subject in the placebo group (n=26).
Participant milestones
| Measure |
AR101 Powder Provided in Capsules
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
AR101 Powder Provided in Capsules
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Baseline characteristics by cohort
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.0 years
n=5 Participants
|
8.0 years
n=7 Participants
|
8.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-9 MonthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment)
The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
|
23 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6-9 monthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
|
1.254 Change from baseline in MTD (log10 mg)
Interval 0.984 to 1.523
|
0.341 Change from baseline in MTD (log10 mg)
Interval 0.057 to 0.626
|
SECONDARY outcome
Timeframe: 6-9 monthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment)
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
0.3 mg
|
0 Participants
|
1 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
3 mg
|
2 Participants
|
2 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
10 mg
|
3 Participants
|
7 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
30 mg
|
1 Participants
|
5 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
100 mg
|
0 Participants
|
6 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
300 mg
|
5 Participants
|
5 Participants
|
|
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
600 mg
|
18 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-9 monthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group.
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Peanut-Specific IgE, Baseline
|
32.571 kUA/L
Interval 18.626 to 56.957
|
53.839 kUA/L
Interval 34.952 to 82.934
|
|
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Peanut-Specific IgE, Exit
|
36.889 kUA/L
Interval 21.258 to 64.015
|
57.060 kUA/L
Interval 37.186 to 87.557
|
|
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Relative Change From Baseline of Peanut-Specific IgGE
|
1.231 kUA/L
Interval 1.027 to 1.475
|
1.060 kUA/L
Interval 1.001 to 1.122
|
SECONDARY outcome
Timeframe: 6-9 monthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment) Relative change from baseline is calculated as the ratio of exit visit result to the baseline result, within treatment group.
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Peanut-Specific IgG4, Baseline
|
0.734 μg/mL
Interval 0.487 to 1.107
|
0.510 μg/mL
Interval 0.344 to 0.757
|
|
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Peanut-Specific IgG4, Exit
|
3.609 μg/mL
Interval 2.074 to 6.281
|
0.540 μg/mL
Interval 0.377 to 0.775
|
|
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Relative Change From Baseline of Peanut-Specific IgG4
|
5.068 μg/mL
Interval 3.64 to 7.055
|
1.066 μg/mL
Interval 0.905 to 1.255
|
SECONDARY outcome
Timeframe: Baseline, 6-9 monthsPopulation: The number of participants analyzed per outcome measure reflects the intent-to-treat (ITT) population (subjects who received at least 1 dose of randomized study treatment)
Outcome measures
| Measure |
AR101 Powder Provided in Capsules
n=29 Participants
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 Participants
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Peanut Wheal, Baseline (mm)
|
14.1 millimeter
Interval 11.6 to 16.7
|
13.7 millimeter
Interval 11.4 to 16.0
|
|
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Peanut Wheal, Exit (mm)
|
7.1 millimeter
Interval 5.7 to 8.6
|
11.8 millimeter
Interval 9.3 to 14.4
|
|
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Change in Peanut Wheel from Baseline (mm)
|
-7.0 millimeter
Interval -9.9 to -4.1
|
-1.8 millimeter
Interval -4.8 to -1.1
|
Adverse Events
AR101 Powder Provided in Capsules
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo Powder Provided in Capsules
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR101 Powder Provided in Capsules
n=29 participants at risk
Study product provided as peanut protein in pull-apart capsules.
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 participants at risk
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
3.4%
1/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
Other adverse events
| Measure |
AR101 Powder Provided in Capsules
n=29 participants at risk
Study product provided as peanut protein in pull-apart capsules.
AR101 powder provided in capsules: Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
|
Placebo Powder Provided in Capsules
n=26 participants at risk
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules: Study product formulated to contain only inactive ingredients for use as defined in the protocol
|
|---|---|---|
|
Immune system disorders
Hypersensitivity
|
89.7%
26/29 • 6-9 months
|
53.8%
14/26 • 6-9 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.9%
2/29 • 6-9 months
|
19.2%
5/26 • 6-9 months
|
|
Infections and infestations
Viral Infection
|
10.3%
3/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.9%
2/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Infections and infestations
Croup Infectious
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Infections and infestations
Ear lobe infection
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Infections and infestations
Gastroenteritis viral
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Molluscum contagiosum
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Otitis externa
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Tinea infection
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • 6-9 months
|
11.5%
3/26 • 6-9 months
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.4%
1/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Gastrointestinal disorders
Dental caries
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
2/29 • 6-9 months
|
11.5%
3/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.3%
3/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • 6-9 months
|
11.5%
3/26 • 6-9 months
|
|
Nervous system disorders
Presyncope
|
3.4%
1/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Nervous system disorders
Somnolence
|
6.9%
2/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
General disorders
Pyrexia
|
17.2%
5/29 • 6-9 months
|
15.4%
4/26 • 6-9 months
|
|
General disorders
Malaise
|
0.00%
0/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Arthropod stings
|
3.4%
1/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.3%
3/29 • 6-9 months
|
7.7%
2/26 • 6-9 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Ear and labyrinth disorders
Ear pain
|
6.9%
2/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Eye disorders
Conjunctivitis allergic
|
3.4%
1/29 • 6-9 months
|
0.00%
0/26 • 6-9 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/29 • 6-9 months
|
3.8%
1/26 • 6-9 months
|
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