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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 They must not have withdrawn voluntarily, be pregnant, or have severe organ issues, life-threatening infections or bleeding, recent live vaccinations, tuberculosis history, or use of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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 3 months.I have had tuberculosis in the past.I have not had severe bleeding in the last 2 weeks.I am currently dealing with a serious infection.I am only using NSAIDs, glucocorticoids, cyclosporine, tacrolimus, or IL-1 inhibitors.I have a history of cancer.I am able to understand and agree to the study's procedures and risks.My organs are significantly failing.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Tadekinig alfa
Awards:
This trial has 2 awards, including:- 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.