Open-Label Extension of EryDex Study IEDAT-04-2022
Purpose
This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Condition
- Ataxia Telangiectasia
Eligibility
- Eligible Ages
- Over 6 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- body weight ≥15 kg - participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
Exclusion Criteria
- safety contraindications for continuation of treatment, as determined by the investigator - clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids - Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years. - requiring treatment with a systemic corticosteroid
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dexamethasone sodium phosphate |
intravenous (IV) infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using the EryDex System (EDS) |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Quince Therapeutics S.p.A.
Detailed Description
The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.