Trials / No Longer Available
No Longer AvailableNCT05095116
Expanded Access Protocol for Patients With Eosinophilic Esophagitis
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Ellodi Pharmaceuticals, LP · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
Summary
This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.
Detailed description
Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APT-1011 3 mg HS | APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient. |
Timeline
- First posted
- 2021-10-27
- Last updated
- 2025-10-03
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05095116. Inclusion in this directory is not an endorsement.