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Tadekinig alfa for Inhibitor of Apoptosis Protein Deficiency
Study Summary
This trial will assess the safety and efficacy of Tadekinig alfa in patients with monogenic, interleukin-18 (IL 18) driven autoinflammation due to Nucleotide-binding oligomerization domain, leucine-rich repeat and caspase recruiting domain (CARD domain) containing 4 (NLRC4) - Macrophage activation syndrome (MAS) mutation (NLRC4-MAS mutation) or X-linked inhibitor of apoptosis (XIAP) deficiency.
- MAS Syndrome
- Inhibitor of Apoptosis Protein Deficiency
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a serious health condition not related to your underlying NLRC4-mutation or XIAP deficiency that could be life-threatening.You are experiencing symptoms related to your brain or nervous system such as seizures, changes in thinking, vision loss or hearing problems.You can participate in the study even if you are taking corticosteroids, NSAIDs, or DMARDs for your condition. If you have tried IL-1 blockade treatment before and it did not work, you can also participate. If you have not taken any of these treatments before, you can still join the study.You currently have or have had cancer in the past that is causing your symptoms.
- Group 1: Tadekinig alfa
- Group 2: 0.9% sodium chloride
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
What is the FDA's stance on Tadekinig alfa?
"Tadekinig alfa's Phase 3 status indicates that while there is some efficacy data, the primary focus has been on safety. So our team rates it a 3."
Could you please direct me to other research that has been conducted on Tadekinig alfa?
"At this moment, there are 2 ongoing clinical trials assessing the efficacy of Tadekinig alfa. These are both Phase 3 studies. Many of these investigations are taking place in La Jolla but other centres across 21 locations in America are also running similar research projects."
Is this a new or unique clinical trial?
"At this moment in time, there are 2 ongoing studies involving Tadekinig alfa. These trials span 11 cities and 3 countries. The first study was completed in 2017 by AB2 Bio Ltd.. In total, 15 patients were observed during Phase 3 of the drug approval process. Since the initial study, 13 more have been undertaken."
Can patients currently sign up for this research study?
"As of today, this clinical trial is still recruiting patients. The listing was first posted on July 21st, 2017 and has been edited as recently as July 25th, 2022."
Is this clinical trial taking place in numerous hospitals across America?
"There are 10 sites for this particular trial, three of which are Children's hospitals. The other seven locations include Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, Children's Healthcare of Atlanta at Egleston in Atlanta, Georgia, and Boston Children's Hospital in Boston, Massachusetts."
How many guinea pigs are allowed to take the experimental drug?
"Fifteen individuals that align with the study's eligibility requirements are necessary to carry out the research. The sponsor, AB2 Bio Ltd., will administer the trial from several locations; two being Cincinnati Children's Hospital Medical Center and Children's Healthcare of Atlanta at Egleston."
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