Trial · NCT02635776
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
NCT02635776, Phase 3, Completed, Aimmune Therapeutics, Inc.; results first posted 2022-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE). Trials, record NCT02635776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02635776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
- NCT number
- NCT02635776
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 555 participants, actual
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Conditions
- Peanut Allergy
- Interventions
- AR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets
- First posted
- 2015-12-21
- Last updated
- 2022-03-17
- Results first posted
- 2022-03-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 12 months | 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. |
| Secondary | 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) | 12 months | 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. |
| Secondary | 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) | 12 months | 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. |
| Secondary | 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) | 12 months | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | AR101 | 250 | Participants | ||
| 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) | Placebo | 5 | Participants | ||
| 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) | AR101 | 187 | Participants | ||
| 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) | Placebo | 3 | Participants | ||
| 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) | AR101 | 285 | Participants | ||
| 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) | Placebo | 10 | Participants | ||
| 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) | AR101 | None | 140 | Participants | |
| 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) | Placebo | None | 3 | Participants | |
| 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) | AR101 | Mild | 119 | Participants | |
| 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) | Placebo | Mild | 35 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 416 | |
| Overall Study | STARTED | Placebo | 139 | |
| Overall Study | COMPLETED | AR101 | 314 | |
| Overall Study | COMPLETED | Placebo | 128 | |
| Overall Study | NOT COMPLETED | AR101 | 102 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events328
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 | Ear pain | Ear and labyrinth disorders | AR101 (Age 4-17) | 0 | 372 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo (Age 4-17) | 0 | 124 | |
| other | Ear pain | Ear and labyrinth disorders | AR101 (Age 18-55) | 0 | 41 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo (Age 18-55) | 1 | 14 | |
| other | Ear pruritus | Ear and labyrinth disorders | AR101 (Age 4-17) | 25 | 372 | |
| other | Ear pruritus | Ear and labyrinth disorders | Placebo (Age 4-17) | 0 | 124 | |
| other | Ear pruritus | Ear and labyrinth disorders | AR101 (Age 18-55) | 0 | 41 | |
| other | Ear pruritus | Ear and labyrinth disorders | Placebo (Age 18-55) | 0 | 14 | |
| other | Conjunctivitis allergic | Eye disorders | AR101 (Age 4-17) | 0 | 372 | |
| other | Conjunctivitis allergic | Eye disorders | Placebo (Age 4-17) | 0 | 124 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AR101 (Age 4-17) | 0 | 372 |
| Total, all-cause mortality | Placebo (Age 4-17) | 0 | 124 |
| Total, all-cause mortality | AR101 (Age 18-55) | 0 | 41 |
| Total, all-cause mortality | Placebo (Age 18-55) | 0 | 14 |
| Total, other adverse events | AR101 (Age 4-17) | 367 | 372 |
| Total, other adverse events | Placebo (Age 4-17) | 118 | 124 |
| Total, other adverse events | AR101 (Age 18-55) | 40 | 41 |
| Total, other adverse events | Placebo (Age 18-55) | 13 | 14 |
| Total, serious adverse events | AR101 (Age 4-17) | 8 | 372 |
| Total, serious adverse events | Placebo (Age 4-17) | 1 | 124 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AR101 vs 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) | Trial comparisons |
| AR101 vs 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) | Trial comparisons |
| AR101 vs 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) | 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/NCT02635776
GET https://conductscience.org/api/trials/v1/NCT02635776/events?page=2