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Interleukin-18 (IL-18) Inhibitor
Tadekinig alfa for Inhibitor of Apoptosis Protein Deficiency
Phase 3
Waitlist Available
Led By Ed M 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 34 weeks
Awards & highlights
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.
Eligible Conditions
- MAS Syndrome
- Inhibitor of Apoptosis Protein Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevention of flares
Secondary outcome measures
Adverse events will be reported
Best response
Change in Physician Global Assessment (PGA)
+16 moreOther outcome measures
Response to therapy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tadekinig alfaExperimental Treatment1 Intervention
Patients that showed response to treatment in the SAOL phase will receive Tadekinig alfa for up to 16 weeks.
Group II: 0.9% sodium chloridePlacebo Group1 Intervention
Patients that showed response to treatment in the SAOL phase will receive placebo comparator for up to 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadekinig alfa
Not yet FDA approved
Find a Location
Who is running the clinical trial?
AB2 Bio Ltd.Lead Sponsor
2 Previous Clinical Trials
33 Total Patients Enrolled
Ed M Behrens, MDPrincipal InvestigatorChildren Hospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Tadekinig alfa
- Group 2: 0.9% sodium chloride
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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