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Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency As Open Label Extension

NCT03512314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-03-17

No results posted yet for this study

Summary

This is an open-label extension study for patients previously enrolled in the AB2 Bio Ltd. ongoing Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953). This OLE study will evaluate the long-term safety and tolerability of Tadekinig alfa in patients suffering from pediatric monogenic autoinflammatory diseases harboring deleterious mutations of NLRC4 and XIAP.

Conditions

  • XIAP Deficiency
  • NLRC4-MAS

Interventions

DRUG

Tadekinig alfa

Open label, 26 weeks on Tadekinig alfa treatment.

Sponsors & Collaborators

  • AB2 Bio Ltd.

    lead INDUSTRY

Principal Investigators

  • Eduard Behrens, MD · Children Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2024-04-08
Completion
2024-05-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • 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 NCT03512314 on ClinicalTrials.gov