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A MULTICENTER, OPEN-LABEL, OUTPATIENT STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF A ZILUCOPLAN AUTO INJECTOR COMBINATION PRODUCT FOR SUBCUTANEOUS SELF-ADMINISTRATION BY STUDY PARTICIPANTS WITH GENERALIZED MYASTHENIA GRAVIS

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508287-30-00
Acronym
DV0013
Enrollment
6
Registered
2024-07-15
Start date
2024-08-29
Completion date
2024-09-30
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

Effective self administrations of zilucoplan using the zilucoplan-auto-injector (ZLP-AI) from Visit 1 to Visit 8.

Detailed description

- Effective self administration of zilucoplan using ZLP-AI at Visit 8 - Effective self administration of zilucoplan using ZLP-AI at Visit 1 - Occurrence of serious adverse events (SAEs) during the course of the study - Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study - Occurrence of nonserious adverse device effects (ADE) during the course of the study - Occurrence of serious adverse device effects (SADE) during the course of the study

Interventions

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Effective self administrations of zilucoplan using the zilucoplan-auto-injector (ZLP-AI) from Visit 1 to Visit 8.

Secondary

MeasureTime frame
- Effective self administration of zilucoplan using ZLP-AI at Visit 8 - Effective self administration of zilucoplan using ZLP-AI at Visit 1 - Occurrence of serious adverse events (SAEs) during the course of the study - Occurrence of treatment-emergent adverse events (TEAEs) during the course of the study - Occurrence of nonserious adverse device effects (ADE) during the course of the study - Occurrence of serious adverse device effects (SADE) during the course of the study

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026