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This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR101 powder provided in capsules | Experimental | Study product provided as peanut protein in pull-apart capsules |
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| Placebo powder provided in capsules | Placebo Comparator | Placebo formulation in pull-apart capsules containing only inactive ingredients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR101 powder provided in capsules | Biological | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 6-9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC | The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge | 6-9 months |
| Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| UC San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34389504 | Derived | Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Powder Provided in Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2014 | Jun 8, 2021 |
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| Placebo powder provided in capsules | Biological | Study product formulated to contain only inactive ingredients for use as defined in the protocol |
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| 6-9 months |
| Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC | 6-9 months |
| Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC | 6-9 months |
| Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline | Baseline, 6-9 months |
| San Diego |
| California |
| 92123 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
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 |
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| NOT COMPLETED |
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These values reflect the intent-to-treat population (subjects who received at least 1 dose of randomized study treatment)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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) | 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) | Posted | Count of Participants | Participants | 6-9 Months |
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| Secondary | Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC | The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Change from baseline in MTD (log10 mg) | 6-9 months |
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| Secondary | Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC | 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) | Posted | Count of Participants | Participants | 6-9 months |
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| Secondary | Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC | 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. | Posted | Geometric Mean | 95% Confidence Interval | kUA/L | 6-9 months |
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| Secondary | Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC | 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. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 6-9 months |
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| Secondary | Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline | 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) | Posted | Mean | 95% Confidence Interval | millimeter | Baseline, 6-9 months |
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6-9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 29 | 1 | 29 | 28 | 29 |
| EG001 | 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 | 0 | 26 | 1 | 26 | 22 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA (16.0) | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Croup Infectious | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Ear lobe infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Molluscum contagiosum | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Tinea infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Arthropod stings | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Skeletal injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
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| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics, Inc. | 650-409-5164 | RegulatoryAffairs@aimmune.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2015 | Jun 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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