A Phase 3 interventional study of AR101 powder provided in capsules & sachets and Placebo powder provided in capsules & sachets in Peanut Allergy, sponsored by Aimmune Therapeutics, Inc.. Completed at 69 sites in 10 countries. Open to participants aged 4 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Aimmune Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Key Inclusion Criteria:
UniCAP™*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies
PRACTALL**: PRACTical issues in ALLergology Joint United States/European Union Initiative
Key Exclusion Criteria:
Study product provided as peanut protein in pull-apart capsules or sachets
Biological: AR101 powder provided in capsules & sachets
Placebo formulation in pull-apart capsules or sachets containing only inactive ingredients
Biological: Placebo powder provided in capsules & sachets
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
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)
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.
Time frame: 12 months
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)
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.
Time frame: 12 months
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)
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.
Time frame: 12 months
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)
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).
Time frame: 12 months
| Milestone | AR101 | Placebo |
|---|---|---|
| Started | 416 | 139 |
| Completed | 314 | 128 |
| Not completed | 102 | 11 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Adverse event | 51 | 3 |
| Withdrew: Withdrawal by subject | 41 | 7 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Other reasons | 5 | 1 |
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.
| Participants | AR101 | Placebo |
|---|---|---|
| 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 | 5 |
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.
| Participants | AR101 | Placebo |
|---|---|---|
| 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 | 3 |
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.
| Participants | AR101 | Placebo |
|---|---|---|
| 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 | 10 |
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).
| Participants | AR101 | Placebo |
|---|---|---|
| None | 140 | 3 |
| Mild | 119 | 35 |
| Moderate | 94 | 73 |
| Severe or worse | 19 | 13 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AR101 (Age 4-17) | 0/372 (0%) | 8/372 (2.2%) | 367/372 (98.7%) |
| Placebo (Age 4-17) | 0/124 (0%) | 1/124 (0.8%) | 118/124 (95.2%) |
| AR101 (Age 18-55) | 0/41 (0%) | 2/41 (4.9%) | 40/41 (97.6%) |
| Placebo (Age 18-55) | 0/14 (0%) | 1/14 (7.1%) | 13/14 (92.9%) |
| Event | AR101 (Age 4-17) | Placebo (Age 4-17) | AR101 (Age 18-55) | Placebo (Age 18-55) |
|---|---|---|---|---|
| Cutaneous vasculitisSkin and subcutaneous tissue disorders | 0/372 | 0/124 | 0/41 | 1/14 |
| Anaphylactic reactionImmune system disorders | 3/372 | 0/124 | 1/41 | 0/14 |
| SyncopeNervous system disorders | 0/372 | 0/124 | 1/41 | 0/14 |
| Humerous fractureInjury, poisoning and procedural complications | 0/372 | 1/124 | 0/41 | 0/14 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/372 | 0/124 | 0/41 | 0/14 |
| GastroenteritisInfections and infestations | 1/372 | 0/124 | 0/41 | 0/14 |
| Gastroenteritis viralInfections and infestations | 1/372 | 0/124 | 0/41 | 0/14 |
| Pharyngitis streptococcalInfections and infestations | 1/372 | 0/124 | 0/41 | 0/14 |
| ConcussionInjury, poisoning and procedural complications | 1/372 | 0/124 | 0/41 | 0/14 |
| Event | AR101 (Age 4-17) | Placebo (Age 4-17) | AR101 (Age 18-55) | Placebo (Age 18-55) |
|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 194/372 | 30/124 | 18/41 | 6/14 |
| DiarrhoeaGastrointestinal disorders | 61/372 | 24/124 | 13/41 | 7/14 |
| NauseaGastrointestinal disorders | 146/372 | 29/124 | 20/41 | 3/14 |
| NasopharyngitisInfections and infestations | 57/372 | 20/124 | 6/41 | 6/14 |
| VomitingGastrointestinal disorders | 154/372 | 30/124 | 5/41 | 3/14 |
| PruritusSkin and subcutaneous tissue disorders | 153/372 | 34/124 | 16/41 | 2/14 |
| Abdominal pain upperGastrointestinal disorders | 152/372 | 26/124 | 16/41 | 4/14 |
| CoughRespiratory, thoracic and mediastinal disorders | 152/372 | 42/124 | 12/41 | 3/14 |
| Throat irritationRespiratory, thoracic and mediastinal disorders | 152/372 | 34/124 | 12/41 | 2/14 |
| Oral pruritusGastrointestinal disorders | 151/372 | 20/124 | 15/41 | 4/14 |
Measure Analysis Population Description: A total of 555 subjects were enrolled. However, only 551 subjects were included in the intent-to-treat (ITT) population. The ITT Population includes all subjects who received at least one dose of randomized study treatment.
| Age, Customized(Participants) | AR101 | Placebo | Total |
|---|---|---|---|
| Age customized categorical — Children (4-11 years) | 238 | 89 | 327 |
| Age customized categorical — Adolescents (12-17 years) | 134 | 35 | 169 |
| Age customized categorical — Adults (18-55 years) | 41 | 14 | 55 |
| Sex: Female, Male(Participants) | AR101 | Placebo | Total |
|---|---|---|---|
| Female | 180 | 56 | 236 |
| Male | 233 | 82 | 315 |
| Ethnicity (NIH/OMB)(Participants) | AR101 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 30 | 17 | 47 |
| Not Hispanic or Latino | 383 | 121 | 504 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AR101 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 44 | 10 | 54 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 6 | 3 | 9 |
| White | 329 | 109 | 438 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 32 | 16 | 48 |
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Aimmune Therapeutics, Inc.