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Tadekinig Alfa

Tadekinig Alfa, also known as recombinant human Interleukin-18 Binding Protein (r-hIL-18BP), is an investigational drug being studied in clinical trials for the treatment of rare autoinflammatory conditions. These trials focus on patients with NLRC4 mutations, XIAP deficiency, and cytokine release syndrome (CRS) related to CAR T cell therapy. The drug aims to block the action of interleukin-18 (IL-18), a key mediator in systemic inflammatory conditions, potentially offering new hope for patients with these challenging disorders.

Table of Contents

What is Tadekinig Alfa?

Tadekinig alfa, also known as r-hIL-18BP or IL-18BP, is an innovative medication being studied for the treatment of rare inflammatory conditions[1]. It is a type of protein called a recombinant human interleukin-18 binding protein. This means it’s a laboratory-made version of a protein that naturally occurs in the human body[3].

What Conditions Does Tadekinig Alfa Treat?

Tadekinig alfa is being investigated for several rare conditions characterized by excessive inflammation in the body. These include:

  • NLRC4-MAS (NLRC4 mutation-associated Macrophage Activation Syndrome): A genetic condition that causes the immune system to become overactive, leading to severe inflammation[1].
  • XIAP Deficiency: A rare genetic disorder that affects the immune system and can cause a severe inflammatory condition called hemophagocytic lymphohistiocytosis (HLH)[1].
  • Cytokine Release Syndrome (CRS): A condition that can occur as a side effect of certain cancer treatments, particularly CAR T-cell therapy[2].
  • HLH-like Syndrome: A severe inflammatory condition that can occur as a complication of other treatments or diseases[2].

How Does Tadekinig Alfa Work?

Tadekinig alfa works by binding to and neutralizing a substance in the body called interleukin-18 (IL-18). IL-18 is a key player in the body’s inflammatory response. In the conditions that Tadekinig alfa is designed to treat, there’s often too much IL-18, leading to excessive inflammation[2]. By binding to IL-18, Tadekinig alfa helps to reduce this inflammation and alleviate symptoms.

How is Tadekinig Alfa Administered?

Tadekinig alfa is given as a subcutaneous injection, which means it’s injected just under the skin. The injection sites are typically rotated between the thighs, arms, and abdomen to minimize injection site reactions[2]. The dosage and frequency of administration can vary depending on the specific condition being treated and the individual patient’s needs.

Current Clinical Trials

Tadekinig alfa is currently being studied in several clinical trials:

  • A Phase 3 study for patients with NLRC4-MAS and XIAP deficiency[3].
  • An open-label extension study to monitor long-term safety and tolerability in patients with NLRC4 mutation and XIAP deficiency[1].
  • A pilot study evaluating its use as a rescue therapy for CAR T-cell related cytokine release syndrome and HLH-like syndrome[2].

Safety and Side Effects

As with any medication, researchers are closely monitoring the safety of Tadekinig alfa. Common areas of focus include:

  • Adverse events (side effects)[3]
  • Changes in physical examination findings and vital signs[3]
  • Changes in laboratory test results[3]
  • Development of antibodies against the medication (immunogenicity)[3]
  • Local reactions at the injection site[3]

It’s important to note that as Tadekinig alfa is still in clinical trials, not all potential side effects may be known. Patients participating in these trials are closely monitored by healthcare professionals.

Aspect Details
Drug Name Tadekinig Alfa (r-hIL-18BP)
Mechanism of Action Interleukin-18 binding protein that neutralizes IL-18
Conditions Studied NLRC4 mutations, XIAP deficiency, CRS related to CAR T cell therapy
Administration Subcutaneous injection
Primary Outcomes Safety, tolerability, adverse events, immunogenicity, local tolerability
Study Designs Open-label extension, randomized withdrawal, pilot study
Duration Varies by study (26 weeks to 34 weeks)
Key Measurements CRP, ferritin levels, mAIDAI score, prevention of flares, duration of response

FAQ

  • What is Tadekinig Alfa? Tadekinig Alfa is an investigational drug that acts as an interleukin-18 binding protein. It is designed to bind and neutralize IL-18, a key mediator in systemic inflammatory conditions such as macrophage activation syndrome (MAS) and hemophagocytic lymphohistiocytosis (HLH).
  • What conditions are being studied in the clinical trials for Tadekinig Alfa? The clinical trials are studying Tadekinig Alfa for rare autoinflammatory conditions, including NLRC4 mutations, XIAP deficiency, and cytokine release syndrome (CRS) related to CAR T cell therapy.
  • How is Tadekinig Alfa administered in these trials? Tadekinig Alfa is administered via subcutaneous injection. The injection sites are rotated to avoid injection site reactions, and may include the outside of the thighs, arms, and various quadrants of the anterior abdominal wall.
  • What are the primary outcomes being measured in these trials? The primary outcomes being measured include the safety and tolerability of Tadekinig Alfa, reports of adverse events, abnormal physical examinations, abnormal laboratory results, immunogenicity evaluation, and local tolerability at the injection site.
  • How long do the clinical trials for Tadekinig Alfa last? The duration of the trials varies. One study includes an 18-week single-arm, open-label phase followed by a 16-week randomized withdrawal period. Another study is an open-label extension lasting 26 weeks.

Ongoing Clinical Trials on Tadekinig Alfa

  • Study on Tadekinig Alfa for Patients with NLRC4 Mutation and XIAP Deficiency

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Tadekinig Alfa: An investigational drug that acts as an interleukin-18 binding protein, designed to bind and neutralize IL-18 in systemic inflammatory conditions.
  • NLRC4 Mutation: A genetic mutation affecting the NLRC4 gene, which can lead to autoinflammatory conditions characterized by recurrent fever and inflammation.
  • XIAP Deficiency: A rare genetic disorder caused by mutations in the XIAP gene, leading to a dysfunctional immune system and increased susceptibility to certain infections and inflammatory conditions.
  • Cytokine Release Syndrome (CRS): A systemic inflammatory response that can occur as a side effect of certain immunotherapies, particularly CAR T cell therapy.
  • Macrophage Activation Syndrome (MAS): A severe complication of rheumatic diseases, characterized by excessive activation and expansion of T lymphocytes and macrophages.
  • Hemophagocytic Lymphohistiocytosis (HLH): A severe systemic inflammatory condition caused by excessive activation of the immune system.
  • Interleukin-18 (IL-18): A pro-inflammatory cytokine that plays a key role in various inflammatory and autoimmune conditions.
  • CAR T cell therapy: A type of immunotherapy where a patient's T cells are modified to target and attack cancer cells.
  • Autoinflammatory disease: A group of disorders characterized by seemingly unprovoked inflammation due to abnormalities in the innate immune system.
  • Subcutaneous injection: A method of administering medication by injecting it into the layer of tissue between the skin and the muscle.

References

  1. https://clinicaltrials.eu/trial/study-on-tadekinig-alfa-for-patients-with-nlrc4-mutation-and-xiap-deficiency/
  2. https://clinicaltrials.gov/study/NCT05306080
  3. https://clinicaltrials.gov/study/NCT03113760