Study of Re-Treatment With ALXN2220 in Patients With ATTR-CM
- Registration Number
- NCT07213583
- Lead Sponsor
- Neurimmune AG
- Brief Summary
This is a Phase 2, single-arm, multicenter study to evaluate the pharmacodynamics and safety of re-treatment with ALXN2220 in previous participants of Study NI006-101.
- Detailed Description
This is a Phase 2, single arm, multicenter study to evaluate the pharmacodynamics and safety of re-treatment with ALXN2220 in the patient population of previous participants in Study NI006-101.
The study will also explore changes in cardiac structure and function, and clinical function of this dosing regimen, as well as changes in cardiac amyloid load, structure and function during the treatment-pause since conclusion of Study NI006-101. The study consists of a Screening Period and a 48 week Active Treatment Period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- Must have received at least one dose of ALXN2220 in Study NI006-101
- Suspected or known intolerance/allergy to proteins or any components of the study drug
- Treatment or study discontinuation in Study NI006-101 due to a treatment-related adverse event that was serious, severe or life-threatening (on Common terminology criteria for adverse events (CTCAE) scale)
- Any new or uncontrolled condition after completion of Study NI006-101 that could make the participant unsuitable for participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALXN2220 ALXN2220 Participants will receive ALXN2220 via intravenous (IV) infusion during the Active Treatment Period
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 48 in ECV measured by cMRI Baseline, Week 48 Change from Baseline to Week 48 in Heart Retention/Whole Body Retention measured by scintigraphy Baseline, Week 48
- Secondary Outcome Measures
Name Time Method Incidence of TEAEs, including serious TEAEs From Baseline up to Week 48 ALXN2220 serum concentrations From Baseline up to Week 48 Incidence of Anti-Drug Antibodies From Baseline up to Week 48
Trial Locations
- Locations (6)
Hôpital Henri Mondor
🇫🇷Créteil, France
CHU de Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hôpital Henri Mondor🇫🇷Créteil, France