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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

Study Summary

This trial is for children with monogenic autoinflammatory diseases who have mutations of NLRC4 and XIAP. The purpose is to see if the drug is safe and effective long-term.

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 They must not have withdrawn voluntarily, be pregnant, or have severe organ issues, life-threatening infections or bleeding, recent live vaccinations, tuberculosis history, or use of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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of the local tolerability at the injection site

Immunogenicity evaluation

Reports of abnormal laboratory results

+2 more

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this particular research been undertaken before?

"Research into Tadekinig alfa began in 2017. The very first study was sponsored by AB2 Bio Ltd. and was conducted that same year. Following the initial trial, which involved 15 participants, Tadekinig alfa received approval for Phase 3 clinical trials. Today, there are two ongoing studies involving Tadekinig alfa being conducted across 11 cities in three different countries."

Answered by AI

Does Tadekinig alfa have any life-threatening side effects?

"Tadekinig alfa's safety is supported by efficacy data as well as multiple rounds of safety trials, giving it a score of 3."

Answered by AI

What else is known about Tadekinig alfa from other research?

"The first clinical trial for tadekinig alfa was completed in 2017 at the UCSD Department of Pediatrics / Rady Children's Hospital. As of now, there is a total of 1 completed trial. Currently, there are 2 live clinical trials, a majority of which are based in Toronto, Canada."

Answered by AI

Is this research still open to new participants?

"Yes, this trial is still looking for patients. Based on information found on clinicaltrials.gov, the trial was originally posted on January 24th, 2018 and was most recently edited on July 21st, 2022. They are currently enrolling 10 participants from 8 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency as Open Label Extension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03512314.