Lanadelumab in FXII-associated Cold Autoinflammatory Syndrome (FACAS)

NCT04278885 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-01-08

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278885 on ClinicalTrials.gov