Trials / Terminated
TerminatedNCT05243719
Open-label Extension Study of ADP101
An Open-Label Extension Study Evaluating the Safety and Efficacy of ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults (The Encore Study)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Alladapt Immunotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 57 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).
Detailed description
This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ADP101 | Active dry powder formulation at various volumes. |
Timeline
- Start date
- 2022-03-14
- Primary completion
- 2024-02-27
- Completion
- 2024-02-27
- First posted
- 2022-02-17
- Last updated
- 2024-03-26
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05243719. Inclusion in this directory is not an endorsement.