drugset / Trial / NCT04056299

Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

NCT04056299 ↗

Phase 2 Terminated 15 enrolled Aimmune Therapeutics, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.

Timeline

Start
2019-08-20
Primary completion
2020-12-16
Completion
2020-12-28

Outcome

Outcome not reported

Stopped (Enrollment): “The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator AR201 Unknown — Oral

Indications

No indication recorded.