Study of Re-Treatment With ALXN2220 in Patients With ATTR-CM
NCT ID: NCT07213583
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2025-08-28
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALXN2220
Participants will receive ALXN2220 via intravenous (IV) infusion during the Active Treatment Period
ALXN2220
Participants will receive ALXN2220 via IV infusion.
Interventions
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ALXN2220
Participants will receive ALXN2220 via IV infusion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Neurimmune AG
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2025-520506-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
NI006-102
Identifier Type: -
Identifier Source: org_study_id