Trial · NCT02993107
PALISADE Follow-on Study (ARC004)
NCT02993107, Phase 3, Completed, Aimmune Therapeutics, Inc.; results first posted 2021-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PALISADE Follow-on Study (ARC004). Trials, record NCT02993107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PALISADE Follow-on Study (ARC004)
- NCT number
- NCT02993107
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 388 participants, actual
- Lead sponsor
- Aimmune Therapeutics, Inc.
- Conditions
- Peanut Allergy
- Interventions
- AR101
- First posted
- 2016-12-15
- Last updated
- 2022-03-17
- Results first posted
- 2021-12-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Up to 126 weeks | Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall). |
| Secondary | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Up to 126 weeks | The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years). |
Source ClinicalTrials.gov
Outcomes2
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 With Treatment-related Adverse Events (TEAE) | Up to 126 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) | Up to 126 weeks | Percent of participants | NUMBER |
Source ClinicalTrials.gov
Results by group66
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 With Treatment-related Adverse Events (TEAE) | Group 1 (Overall) | All AEs | 98 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 1 (QD) | All AEs | 90 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 2 (Overall) | All AEs | 36 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 3A (QD) | All AEs | 27 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 3B (Overall) | All AEs | 28 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 3C (Overall) | All AEs | 33 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 1 (Overall) | SAEs | 0 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 1 (QD) | SAEs | 1 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 2 (Overall) | SAEs | 0 | Participants | |
| Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) | Group 2: Cohort 3A (QD) | SAEs | 0 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (Placebo Crossovers) | 113 | |
| Overall Study | STARTED | Group 2: Cohort 1 (Active Rollovers) | 120 | |
| Overall Study | STARTED | Group 2: Cohort 2 (Active Rollovers) | 50 | |
| Overall Study | STARTED | Group 2: Cohort 3A (Active Rollovers) | 35 | |
| Overall Study | STARTED | Group 2: Cohort 3B (Active Rollovers) | 34 | |
| Overall Study | STARTED | Group 2: Cohort 3C (Active Rollovers) | 36 | |
| Overall Study | Adverse Event | Group 1 (Placebo Crossovers) | 12 | |
| Overall Study | Adverse Event | Group 2: Cohort 1 (Active Rollovers) | 4 | |
| Overall Study | Adverse Event | Group 2: Cohort 2 (Active Rollovers) | 1 | |
| Overall Study | Adverse Event | Group 2: Cohort 3A (Active Rollovers) | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events1,404
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 | Lymphadenopathy | Blood and lymphatic system disorders | Group 1 (Age 4-17 Overall) | 2 | 100 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 1 (Age 4-17 QD) | 0 | 109 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 2 (Age 4-17 Overall) | 0 | 46 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 3A (Age 4-17 QD) | 0 | 31 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 3B (Age 4-17 Overall) | 1 | 31 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 3C (Age 4-17 Overall) | 2 | 34 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 1 (Age 18-55 Overall) | 1 | 11 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 1 (Age 18-55 QD) | 0 | 8 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 2 (Age 18-55 Overall) | 0 | 2 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Group 2: Cohort 3A (Age 18-55 QD) | 0 | 4 |
1 to 10 of 1,404Source ClinicalTrials.gov
See all 1,404 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (Age 4-17 Overall) | 0 | 100 |
| Total, all-cause mortality | Group 2: Cohort 1 (Age 4-17 QD) | 0 | 109 |
| Total, all-cause mortality | Group 2: Cohort 2 (Age 4-17 Overall) | 0 | 46 |
| Total, all-cause mortality | Group 2: Cohort 3A (Age 4-17 QD) | 0 | 31 |
| Total, all-cause mortality | Group 2: Cohort 3B (Age 4-17 Overall) | 0 | 31 |
| Total, all-cause mortality | Group 2: Cohort 3C (Age 4-17 Overall) | 0 | 34 |
| Total, all-cause mortality | Group 1 (Age 18-55 Overall) | 0 | 11 |
| Total, all-cause mortality | Group 2: Cohort 1 (Age 18-55 QD) | 0 | 8 |
| Total, all-cause mortality | Group 2: Cohort 2 (Age 18-55 Overall) | 0 | 2 |
| Total, all-cause mortality | Group 2: Cohort 3A (Age 18-55 QD) | 0 | 4 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers2
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 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/NCT02993107
GET https://conductscience.org/api/trials/v1/NCT02993107/results?page=2