Phase 3
Completed N=388
PALISADE Follow-on Study (ARC004)
Peanut Allergy
Source: ClinicalTrials.gov NCT02993107 ↗
Enrolled (actual)
388
Serious AEs
1.1%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) — 98; 90; 36; 27 Participants
◆ Published Evidence
Established
23citations · ~5 / year
Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Summary
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
Linked Publications (2)
-
Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
-
Post hoc analysis examining symptom severity reduction and symptom absence during food challenges in individuals who underwent oral immunotherapy for peanut allergy: results from three trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE) |
98; 90; 36; 27; 28; 33 | — |
| SECONDARY Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge) |
98.6; 98.1; 94.7; 100.0; 81.8; 90.5 | — |
Eligibility Criteria
Key Inclusion Criteria
- Completion of the ARC003 study
- Written informed consent and/or assent from subjects/guardians as appropriate
- Use of effective birth control by sexually active female subjects of child-bearing potential
Key Exclusion Criteria
- Early discontinuation from the ARC003 study
- Meets any longitudinally applicable ARC003 study exclusion criteria
- (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 study Exit DBPCFC
- Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Data sourced from ClinicalTrials.gov (NCT02993107) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.