Lanadelumab in FXII-associated Cold Autoinflammatory Syndrome (FACAS)
NCT04278885 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2024-01-08
Summary
This is a Phase 2, exploratory, proof-of-concept, single-center, open-label pilot study to assess the effects and safety of Lanadelumab in patients with FXII-associated cold autoinflammatory syndrome (FACAS).
Conditions
- Hereditary Autoinflammatory Disease
Interventions
- DRUG
-
Lanadelumab
300mg Lanadelumab s.c. administration every 2 weeks
Sponsors & Collaborators
-
Shire International GmbH
collaborator UNKNOWN -
Charite University, Berlin, Germany
lead OTHER
Principal Investigators
-
Karoline Krause, Prof. · Charité University, Berlin, Germany
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-05
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Germany
Study Locations
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