Trial · NCT03337542
AR101 Real-World Open-Label Extension Study
NCT03337542, Phase 3, Completed, Aimmune Therapeutics, Inc.; results first posted 2021-11-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AR101 Real-World Open-Label Extension Study. Trials, record NCT03337542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03337542
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AR101 Real-World Open-Label Extension Study
- NCT number
- NCT03337542
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 243 participants, actual
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Conditions
- Peanut Allergy
- Interventions
- AR101
- First posted
- 2017-11-09
- Last updated
- 2021-11-02
- Results first posted
- 2021-11-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Approximately 6 months | Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability) |
| Secondary | Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | |
| Secondary | Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | 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 | Approximately 6 months | |
| Secondary | Number of Participants With Allergic Hypersensitivity Adverse Events | Approximately 6 months | |
| Secondary | Number of Participants With of Anaphylaxis as Defined in the Protocol | Approximately 6 months | Anaphylaxis is likely when any 1 of the 3 following sets of criteria is fulfilled: 1. Acute onset of an illness (minutes to hours) with involvement of: (a) Skin/mucosal tissue (eg, generalized hives, itch/flush, swollen lips/tongue/uvula); AND (b) Airway compromise (eg, dyspnea, stridor, wheeze/bronchospasm, hypoxia, reduced PEFR); AND/OR (c) Reduced BP or associated symptoms (eg, hypotonia, syncope, incontinence). 2. Two or more of the following that occur rapidly after exposure to the allergen (minutes to hours): (a) Skin/mucosal tissue; (b) Airway compromise; (c) Reduced BP or associated symptoms; (d) Persistent GI symptoms (eg, nausea, vomiting, crampy abdominal pain). 3. Reduced BP after exposure to the allergen (minutes to hours). Infants and children: low systolic BP (age-specific) or \> 30% drop in systolic BP; Adults: systolic BP \< 90 mm Hg or \> 30% drop from their baseline. |
| Secondary | Number of Participants With Epinephrine Use as Rescue Medication | Approximately 6 months | |
| Secondary | Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | Number of participants with accidental/nonaccidental ingestion of peanut (not AR101 or food challenge material) and other allergenic foods. |
| 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 | 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) | 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). |
| 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 | 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) | 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). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101 | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Approximately 6 months | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Allergic Hypersensitivity Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101.~Threshold of allergic hypersensitivity AE reporting ≥ 5% | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With of Anaphylaxis as Defined in the Protocol | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Epinephrine Use as Rescue Medication | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of AR101. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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) | 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 | score on a scale | MEAN |
| 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 | 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) | 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 | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Subjects with at least 1 Adverse Event (AE) | 219 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Mild AE | 176 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Moderate AE | 43 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Severe AE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Life-threatening AE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Death AE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Subjects with at least 1 Serious Adverse Event (SAE) | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Mild SAE | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Moderate SAE | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) | AR101 | Severe SAE | 0 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AR101 | 243 | |
| Overall Study | Safety Population | AR101 | 242 | |
| Overall Study | COMPLETED | AR101 | 222 | |
| Overall Study | NOT COMPLETED | AR101 | 21 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Treatment Arm Description | 45 | 242 | |
| other | Vomiting | Gastrointestinal disorders | Treatment Arm Description | 39 | 242 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Arm Description | 34 | 242 | |
| other | Nausea | Gastrointestinal disorders | Treatment Arm Description | 30 | 242 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment Arm Description | 15 | 242 | |
| other | Oral pruritis | Gastrointestinal disorders | Treatment Arm Description | 15 | 242 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment Arm Description | 47 | 242 | |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | Treatment Arm Description | 43 | 242 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Treatment Arm Description | 23 | 242 | |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Treatment Arm Description | 23 | 242 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm Description | 0 | 242 |
| Total, other adverse events | Treatment Arm Description | 219 | 242 |
| Total, serious adverse events | Treatment Arm Description | 1 | 242 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34389504 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03337542
GET https://conductscience.org/api/trials/v1/NCT03337542/results?page=2