Phase 2
Completed N=47
Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
Peanut Allergy
Source: ClinicalTrials.gov NCT02198664 ↗
Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months — 26; 21; 1; 1 Participants
Summary
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months |
26; 21; 1; 1; 25; 15 | — |
| SECONDARY The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC |
20; 19 | — |
| SECONDARY The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC. |
20; 20; 20; 18; 17; 14 | — |
| SECONDARY Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein |
38.90; NA; 501.2; 524.8; 776.2; 758.6 | — |
| SECONDARY Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated |
1; 0; 3; 4; 17; 17 | — |
| SECONDARY Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance |
56.826; NA; 59.145; 29.964; 14.880; 10.381 | — |
| SECONDARY Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance |
0.538; NA; 3.004; 4.096; 5.755; 12.429 | — |
| SECONDARY Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance |
11.8; NA; 8.6; 6.6; 9.0; 5.1 | — |
| SECONDARY Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC |
11; 18; 0; 3; 0; 0 | — |
| SECONDARY Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC |
7; 9; 0; 1; 0; 0 | — |
| SECONDARY Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance. |
36.4; NA; 34.9; 25.6; 27.5; 20.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Completion of ARC001 study
- No change in the status of any longitudinally applicable ARC001 inclusion criteria
Key Exclusion Criteria
- Early termination from ARC001
- Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
- A lapse in dosing of more than 10 days from completion of ARC001
- Change in the status of any longitudinally applicable ARC001 exclusion criteria
Data sourced from ClinicalTrials.gov (NCT02198664). 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.