Phase 3
Completed N=243
AR101 Real-World Open-Label Extension Study
Peanut Allergy
Source: ClinicalTrials.gov NCT03337542 ↗
Enrolled (actual)
243
Serious AEs
0.4%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) — 219; 176; 43; 0 Participants
◆ Published Evidence
Established
23citations · ~5 / year
Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Linked Publications
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Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) |
219; 176; 43; 0; 0; 0 | — |
| SECONDARY Number of Participants With Premature Discontinuation of Dosing Due to Adverse Events |
1 | — |
| SECONDARY Number of Participants With Early Discontinuation of Dosing Due to Chronic/Recurrent GI Adverse Events |
1 | — |
| SECONDARY Percentage of Subjects With Chronic/Recurrent GI Adverse Events Resolving Before 2, Between 2 and 4, Between 4 and 12, and ≥ 12 Weeks After Discontinuation of Dosing |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Allergic Hypersensitivity Adverse Events |
43; 39; 30; 28; 27; 24 | — |
| SECONDARY Number of Participants With of Anaphylaxis as Defined in the Protocol |
21 | — |
| SECONDARY Number of Participants With Epinephrine Use as Rescue Medication |
19 | — |
| SECONDARY Number of Participants With Accidental/Nonaccidental Ingestion of Peanut and Other Allergenic Foods |
33 | — |
| SECONDARY Assessment of Asthma Control Using the Childhood Asthma Control Test (C-ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 4-11 |
24; 24.4; 25.0; 25.0; 25.3; 24.8 | — |
| SECONDARY Assessment of Asthma Control Using the Asthma Control Test (ACT) Questionnaire Total Score From Baseline, Every 4 Weeks, Early Discontinuation and Study Exit, Ages 12-17 |
23.3; 23.8; 23.9; 23.7; 23.3; 23.6 | — |
| SECONDARY Number of Participants With Adverse Events That Led to Early Withdrawal |
1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing potential
Key Exclusion Criteria
- Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
- Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
- Currently in the build-up phase of immunotherapy for any nonfood allergen.
- Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
Data sourced from ClinicalTrials.gov (NCT03337542) 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.