Status:
ACTIVE_NOT_RECRUITING
Study of Re-Treatment With ALXN2220 in Patients With ATTR-CM
Lead Sponsor:
Neurimmune AG
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Amyloid Transthyretin Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- Must have received at least one dose of ALXN2220 in Study NI006-101
Exclusion
- 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
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07213583
Start Date
August 28 2025
End Date
October 31 2026
Last Update
December 19 2025
Active Locations (6)
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1
Hôpital Henri Mondor
Créteil, France, 94000
2
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
3
CHU Toulouse - Hôpital Rangueil
Toulouse, France, 31059
4
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120