Trial · NCT03126227
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
NCT03126227, 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. Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES). Trials, record NCT03126227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126227
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
- NCT number
- NCT03126227
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Conditions
- Peanut Allergy
- Interventions
- AR101, Placebo
- First posted
- 2017-04-24
- 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 | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Approximately 6 months | Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product. |
| Secondary | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | |
| Secondary | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Approximately 6 months | |
| Secondary | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Approximately 6 months | |
| Secondary | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Approximately 6 months | |
| Secondary | Frequency 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 | Frequency of Epinephrine Use as Rescue Medication | Approximately 6 months | |
| Secondary | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | |
| Secondary | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 4-11 years included 4 questions for the subject and 3 questions for the parent; the total score (sum of 7 questions) ranged from 0 (worst control) to 27 (total control) |
| Secondary | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | The Asthma Control Test (ACT) Questionnaire ACT for subjects aged 12-17 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 | Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Chronic/Recurrent Gastrointestinal Adverse Events Resolving <2, Between 2-4, Between 4-12, and ≥ 12 Weeks Following Discontinuation of Dosing | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment.~Number of participants analyzed: subjects who discontinued dosing due to chronic/recurrent gastrointestinal adverse events.~None of the subjects in Placebo group discontinued dosing due to chronic/recurrent gastrointestinal adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Allergic Hypersensitivity Adverse Events Normalized for Duration of Treatment | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | number of events | NUMBER |
| SECONDARY | Frequency of Anaphylaxis as Defined in the Protocol | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Epinephrine Use as Rescue Medication | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Approximately 6 months | Safety population defined as all subjects who received at least 1 dose of randomized study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 4-11 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 4-11 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Change in ACT total score from baseline | MEAN |
| SECONDARY | Change of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline to Interim (80 mg), End of Up-Dosing (300 mg) and Study Exit, Ages 12-17 | Baseline, Interim dose (approx. 10 weeks), End of Up-Dosing (20 to 40 weeks), Study Exit (14 days after End of Up-Dosing, usually approx. 6 months) | Safety population defined as all subjects who received at least 1 dose of randomized study treatment (included subjects ages 12-17 only).~The ACT questionnaire was not completed by all subjects and/or parents at all protocol-defined points of collection. | Change in ACT total score from baseline | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | AR101 Powder Provided in Capsules | Subjects with at least 1 AE | 334 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Placebo Powder | Subjects with at least 1 AE | 159 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | AR101 Powder Provided in Capsules | Mild AE | 171 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Placebo Powder | Mild AE | 110 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | AR101 Powder Provided in Capsules | Moderate AE | 151 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Placebo Powder | Moderate AE | 47 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | AR101 Powder Provided in Capsules | Severe AE | 11 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Placebo Powder | Severe AE | 1 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | AR101 Powder Provided in Capsules | Life Threatening AE | 1 | Participants | |
| Frequency of Treatment Emergent Adverse Events, Including Serious Adverse Events | Placebo Powder | Life Threatening AE | 0 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AR101 Powder Provided in Capsules | 338 | |
| Overall Study | STARTED | Placebo Powder | 168 | |
| Overall Study | COMPLETED | AR101 Powder Provided in Capsules | 260 | |
| Overall Study | COMPLETED | Placebo Powder | 158 | |
| Overall Study | NOT COMPLETED | AR101 Powder Provided in Capsules | 78 | |
| Overall Study | NOT COMPLETED | Placebo Powder | 10 |
Source ClinicalTrials.gov
Adverse events88
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 pain | Gastrointestinal disorders | AR101 Powder Provided in Capsules | 177 | 337 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Powder | 34 | 168 | |
| other | Abdominal discomfort | Gastrointestinal disorders | AR101 Powder Provided in Capsules | 137 | 337 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo Powder | 27 | 168 | |
| other | Vomiting | Gastrointestinal disorders | AR101 Powder Provided in Capsules | 130 | 337 | |
| other | Vomiting | Gastrointestinal disorders | Placebo Powder | 28 | 168 | |
| other | Nausea | Gastrointestinal disorders | AR101 Powder Provided in Capsules | 114 | 337 | |
| other | Nausea | Gastrointestinal disorders | Placebo Powder | 20 | 168 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AR101 Powder Provided in Capsules | 75 | 337 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Powder | 24 | 168 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AR101 Powder Provided in Capsules | 0 | 337 |
| Total, all-cause mortality | Placebo Powder | 1 | 168 |
| Total, other adverse events | AR101 Powder Provided in Capsules | 334 | 337 |
| Total, other adverse events | Placebo Powder | 159 | 168 |
| Total, serious adverse events | AR101 Powder Provided in Capsules | 2 | 337 |
| Total, serious adverse events | Placebo Powder | 2 | 168 |
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Epinephrine Use as Rescue Medication | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Accidental Ingestion of Peanut and Other Allergenic Foods | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Adverse Events That Led to Early Withdrawal | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Premature Discontinuation of Dosing Due to Adverse Events | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Anaphylaxis as Defined in the Protocol | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: Frequency of Premature Discontinuation of Dosing Due to Chronic/Recurrent Gastrointestinal Adverse Events | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: deaths from any cause | Trial comparisons |
| AR101 Powder Provided in Capsules vs Placebo Powder: serious adverse events | Trial comparisons |
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/NCT03126227
GET https://conductscience.org/api/trials/v1/NCT03126227/results?page=2