Trials / Terminated
TerminatedNCT04056299
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
Phase 2 Study of AR201 Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 26 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was conducted at 8 sites in the United States.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR201 powder | AR201 powder (Hen Egg allergen formulation) provided in capsules |
| BIOLOGICAL | Placebo powder | Placebo powder provided in capsules |
Timeline
- Start date
- 2019-08-20
- Primary completion
- 2020-12-16
- Completion
- 2020-12-28
- First posted
- 2019-08-14
- Last updated
- 2022-03-10
- Results posted
- 2022-02-28
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04056299. Inclusion in this directory is not an endorsement.