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NCT03736447 · ClinicalTrials.gov registry record · Phase 3
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization
A Phase 3 study, sponsored by Aimmune Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 146
- Enrollment target
NCT03736447: Completed Phase 3 study, sponsored by Aimmune Therapeutics.
NCT03736447 is a Phase 3 study that has completed, run by Aimmune Therapeutics. The registered enrollment target is 146 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03736447, a Phase 3 study, has completed, sponsored by Aimmune Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 146 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to \< 4 years.
Primary Outcome
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 allergy symptoms during the exit double-blind placebo-controlled food challenge (DBPCFC).
Interventions
- BIOLOGICAL AR101 powder provided in capsules & sachets
- BIOLOGICAL Placebo powder provided in capsules & sachets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2018-12-27 |
| Est. Completion | 2022-07-05 |
| Phase | Phase 3 |
What the finished NCT03736447 record still lists
NCT03736447 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which AR101 powder provided in capsules & sachets is the first listed.
NCT03736447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03736447 about?
NCT03736447 is a clinical study titled "Peanut Oral Immunotherapy Study of Early Intervention for Desensitization". The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to \< 4 years.
What is the current status of trial NCT03736447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2018-12-27. Estimated completion is 2022-07-05.
What interventions are being tested in trial NCT03736447?
The interventions under investigation include: AR101 powder provided in capsules & sachets (BIOLOGICAL), Placebo powder provided in capsules & sachets (BIOLOGICAL).
Who is sponsoring clinical trial NCT03736447?
This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03736447's enrollment target sits among peer trials
146 1551st of 2000 higher than 446 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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