Trials / Terminated
TerminatedNCT03703791
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real World, Open Label, Quality of Life Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
Detailed description
This is a phase 3b, randomized, open label, European study of the HRQOL of AR101 in combination with standard of care compared with standard of care alone in approximately 200 peanut-allergic subjects aged 4 to 17 years, inclusive.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 | AR101 powder |
Timeline
- Start date
- 2018-10-24
- Primary completion
- 2018-11-23
- Completion
- 2018-11-23
- First posted
- 2018-10-12
- Last updated
- 2021-07-13
- Results posted
- 2021-07-13
Locations
11 sites across 1 country: Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03703791. Inclusion in this directory is not an endorsement.