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Interleukin Antagonist

Tadekinig Alfa for Genetic Autoinflammatory Diseases

Phase 3
Waitlist Available
Led By Eduard Behrens, MD
Research Sponsored by AB2 Bio Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Vaccination with a live vaccine within the previous 3 months
History of tuberculosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing Tadekinig alfa, a drug that blocks a protein called IL-18 to reduce inflammation. It targets children with specific genetic conditions causing severe inflammation. The goal is to manage their symptoms until they can receive a stem cell transplant.

Who is the study for?
This trial is for patients with specific genetic disorders (NLRC4 mutation or XIAP deficiency) who were in a previous Phase III study and either completed it or needed rescue immunosuppression. They must not have withdrawn voluntarily, be pregnant, or have severe organ issues, life-threatening infections or bleeding, recent live vaccinations, tuberculosis history, or use of certain immunosuppressants.
What is being tested?
The trial tests the long-term safety and effectiveness of Tadekinig alfa in children with monogenic autoinflammatory diseases due to NLRC4 mutations/XIAP deficiency. It's an extension for those who've been part of a prior related trial.
What are the potential side effects?
While specific side effects are not listed here, generally such treatments may cause immune system reactions, potential organ inflammation due to overactive immune responses and could interact with other medications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 3 months.
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I have had tuberculosis in the past.
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I am currently dealing with a serious infection.
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I have a history of cancer.
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I am able to understand and agree to the study's procedures and risks.
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My organs are significantly failing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of the local tolerability at the injection site
Immunogenicity evaluation
Reports of abnormal laboratory results
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tadekinig alfaExperimental Treatment1 Intervention
Active drug treatment during 26 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadekinig alfa
2017
Completed Phase 3
~20

Find a Location

Who is running the clinical trial?

AB2 Bio Ltd.Lead Sponsor
2 Previous Clinical Trials
38 Total Patients Enrolled
Eduard Behrens, MDPrincipal InvestigatorChildren Hospital of Philadelphia

Media Library

Tadekinig alfa (Interleukin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03512314 — Phase 3
Tadekinig alfa (Interleukin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03512314 — Phase 3
MAS Syndrome Research Study Groups: Tadekinig alfa
MAS Syndrome Clinical Trial 2023: Tadekinig alfa Highlights & Side Effects. Trial Name: NCT03512314 — Phase 3
~1 spots leftby Nov 2025
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