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This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm description | Other | Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR101 | Biological | AR101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability) | Approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | |
| Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | Approximately 6 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director of Regulatory Affairs | Aimmune Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Medical Research of Arizona |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | AR101 | Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance. AR101: AR101 powder provided in sachets |
| 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 | Aug 20, 2018 | Jun 22, 2021 |
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| Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | Approximately 6 months |
| Number of Participants With Allergic Hypersensitivity Adverse Events | Approximately 6 months |
| Number of Participants With of Anaphylaxis as Defined in the Protocol | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
| Approximately 6 months |
| Number of Participants With Epinephrine Use as Rescue Medication | Approximately 6 months |
| Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods. | Approximately 6 months |
| Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control). | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) |
| Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) |
| Number of Participants With Adverse Events That Led to Early Withdrawal | Approximately 6 months |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| Jonathan Corren, M.D., Inc. | Los Angeles | California | 90025 | United States |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | 92691 | United States |
| Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital | Mountain View | California | 94040 | United States |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | United States |
| Allergy & Asthma Medical Group and Research Center | San Diego | California | 92123 | United States |
| Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego | San Diego | California | 92123 | United States |
| UCSF, Benioff Children's Hospital - Allergy and Immunology | San Francisco | California | 95148 | United States |
| Allergy & Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States |
| UCLA Medical Center, Santa Monica | Santa Monica | California | 90404 | United States |
| Bay Area Allergy | Walnut Creek | California | 94598 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Asthma & Allergy Associates | Colorado Springs | Colorado | 80907 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Colorado Allergy & Asthma Centers, P.C. | Denver | Colorado | 80230 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Sher Allergy Specialists - Center for Cough | Largo | Florida | 33778 | United States |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | United States |
| Sarasota Clinical Research Windom Allergy, Asthma and Sinus | Sarasota | Florida | 34239 | United States |
| University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit | Tampa | Florida | 33613 | United States |
| Atlanta Allergy & Asthma Clinic | Marietta | Georgia | 30060 | United States |
| Idaho Allergy and Research | Eagle | Idaho | 83616 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | United States |
| The University of Chicago Medicine, Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
| Sneeze, Wheeze, & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| Family Allergy & Asthma Research Institute | Louisville | Kentucky | 40215 | United States |
| Chesapeake Clinical Research, Inc. | Baltimore | Maryland | 21236 | United States |
| Johns Hopkins Hospital, Pediatric Clinical Research Unit | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Division of Allergy and Clinical Immunology | Ann Arbor | Michigan | 48106 | United States |
| Clinical Research Institute, Inc. | Plymouth | Minnesota | 55441 | United States |
| Children's Mercy on Broadway | Kansas City | Missouri | 64111 | United States |
| Atlantic Research Center | Ocean City | New Jersey | 07712 | United States |
| Princeton Center for Clinical Research | Skillman | New Jersey | 08558 | United States |
| Northwell Health System | Great Neck | New York | 11021 | United States |
| Univ. of Rochester Medical Center, Golisano Children's Hosp. | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill, Clinical & Translational Research Center | Chapel Hill | North Carolina | 27599 | United States |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Oklahoma Institute of Allergy and Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | United States |
| Columbia Asthma & Allergy Clinic | Clackamas | Oregon | 97015 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| National Allergy and Asthma Research, LLC | North Charleston | South Carolina | 29420 | United States |
| Specially for Children Allergy, Asthma and Immunology Clinic | Austin | Texas | 78723 | United States |
| Children's Health | Dallas | Texas | 75235 | United States |
| Western Sky Medical Research | El Paso | Texas | 79903 | United States |
| Texas Children's Hospital, Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| ASTHMA Inc. Clinical Research Center | Seattle | Washington | 98115-2024 | United States |
| McMaster University Medical Center | Hamilton | Ontario | L8N 3Z5 | Canada |
| Triple A Lab / Hamilton Allergy | Hamilton | Ontario | L8S 1G5 | Canada |
| Cheema Research Inc. (CRI) | Mississauga | Ontario | L5A 3V4 | Canada |
| Ottawa Allergy Research Corp | Ottawa | Ontario | K1G 6C6 | Canada |
| Gordon Sussman Clinical Research | Toronto | Ontario | M4V 1R2 | Canada |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 243 subjects were enrolled. However, only 242 subjects were included in Safety Population. The Safety Population is defined as all subjects who received at least 1 dose of AR101.
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| ID | Title | Description |
|---|---|---|
| BG000 | AR101 | Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance. AR101: AR101 powder provided in sachets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was calculated relative to the date of informed consent in ARC007 | Median | Full Range | years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability) | Safety population defined as all subjects who received at least 1 dose of AR101. | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | Safety population defined as all subjects who received at least 1 dose of AR101 | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | Safety population defined as all subjects who received at least 1 dose of AR101 | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing | Safety population defined as all subjects who received at least 1 dose of AR101 Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events. | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Allergic Hypersensitivity Adverse Events | Safety population defined as all subjects who received at least 1 dose of AR101. Threshold of allergic hypersensitivity AE reporting ≥ 5% | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With of Anaphylaxis as Defined in the Protocol | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled:
| Safety population defined as all subjects who received at least 1 dose of AR101. | Posted | Count of Participants | Participants | Approximately 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Epinephrine Use as Rescue Medication | Safety population defined as all subjects who received at least 1 dose of AR101. | Posted | Count of Participants | Participants | Approximately 6 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods. | Safety population defined as all subjects who received at least 1 dose of AR101. | Posted | Count of Participants | Participants | Approximately 6 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 | The C-ACT for subjects aged 4 to 11 years included 4 questions for the subject and 3 questions for the parent/caregiver; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control). | Safety population defined as all subjects who received at least 1 dose of AR101. The C-ACT questionnaire was not completed by all subjects and/or parents/caregivers at all protocol-defined points of collection | Posted | Mean | Standard Deviation | score on a scale | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 | The ACT for subjects aged 12 to 17 years consisted of 5 questions, and the total score (sum of 5 questions) ranged from 5 (worst control) to 25 (total control). | Safety population defined as all subjects who received at least 1 dose of AR101. The ACT questionnaire was not completed by all subjects and/or parents/caregivers at all protocol-defined points of collection | Posted | Mean | Standard Deviation | score on a scale | Baseline, Maintenance Visit 1 (Wk 4), Maintenance Visit 2 (Wk 8), Maintenance Visit 3 (Wk 12), Maintenance Visit 4 (Wk 16), Maintenance Visit 5 (Wk 20), Maintenance Visit 6 (Wk 24), Early Discontinuation (14 days after last dose), Study Exit (~6 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events That Led to Early Withdrawal | Safety population defined as all subjects who received at least 1 dose of AR101. | Posted | Count of Participants | Participants | Approximately 6 months |
|
|
6 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 | Treatment Arm Description | Subjects will receive maintenance dosing with AR101. Maintenance doses are provided in sachets, where each sachet contains 300 mg of peanut protein. Subjects are to ingest 300 mg orally once a day during maintenance. AR101: AR101 powder provided in sachets | 0 | 242 | 1 | 242 | 219 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oral pruritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
| ||
| Eye pruritus | Eye disorders | Systematic Assessment |
|
| 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 | Mar 12, 2019 | Jun 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Unknown or Not Reported |
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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 |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Severe AE |
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| Life-threatening AE |
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| Death AE |
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| Subjects with at least 1 Serious Adverse Event (SAE) |
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| Mild SAE |
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| Moderate SAE |
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| Severe SAE |
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| Life-threatening SAE |
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| Death SAE |
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| Title | Denominators | Categories | ||||
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