Trials / Completed
CompletedNCT03292484
Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)
A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 911 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 1 Year – 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.
Detailed description
This study is enrolling participants by invitation only. This is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the Aimmune AR101 clinical studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 | AR101 |
Timeline
- Start date
- 2017-11-02
- Primary completion
- 2023-04-27
- Completion
- 2023-04-27
- First posted
- 2017-09-25
- Last updated
- 2024-12-19
- Results posted
- 2024-12-19
Locations
93 sites across 10 countries: United States, Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03292484. Inclusion in this directory is not an endorsement.