Open-label extension study with Tadekinig alfa (r-hIL-18BP) to monitor safety and tolerability in patients with IL-18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504534-21-00

Acronym

OLE-NLRC4/XIAP

Enrollment

Registered

2023-07-04

Start date

2023-10-09

Completion date

2024-05-08

Last updated

2023-11-14

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

Conditions

18 driven monogenic autoinflammatory conditions: NLRC4 mutation and XIAP deficiency

Brief summary

Safety and tolerability of Tadekinig alfa treatment evaluated by reports of adverse events, abnormal laboratory results, Local tolerability, Immunogenicity evaluation and PK/PD determination

Interventions

DRUGTadekinig alfa

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of Tadekinig alfa treatment evaluated by reports of adverse events, abnormal laboratory results, Local tolerability, Immunogenicity evaluation and PK/PD determination	—

Countries

Germany

Outcome results

None listed

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