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Kan-101

KAN-101 is an investigational drug currently being studied in clinical trials for the treatment of Celiac Disease (CeD). These trials aim to evaluate the safety, tolerability, and efficacy of KAN-101 in patients with CeD who are on a gluten-free diet. The studies involve both single and multiple dose administrations of KAN-101 through intravenous infusion, comparing its effects to a placebo. Researchers are particularly interested in understanding how KAN-101 may protect against gluten-induced changes in the small intestine and its overall impact on patients with Celiac Disease.

Table of Contents

What is KAN-101?

KAN-101 is a new drug being developed to treat celiac disease, also known as coeliac disease[2]. It is currently undergoing clinical trials to evaluate its effectiveness and safety in patients with this condition. KAN-101 is administered through intravenous (IV) infusion, which means it is given directly into the bloodstream through a vein[1].

What Condition Does KAN-101 Target?

KAN-101 is specifically designed to treat celiac disease. Celiac disease is an autoimmune disorder where the ingestion of gluten, a protein found in wheat, barley, and rye, leads to damage in the small intestine. This damage can cause various symptoms and complications. Currently, the primary treatment for celiac disease is a strict gluten-free diet, which can be challenging to maintain. KAN-101 aims to provide an additional treatment option for people with celiac disease[1][2].

How is KAN-101 Administered?

KAN-101 is given to patients through intravenous (IV) infusion. This means that the medication is delivered directly into the bloodstream through a vein. The administration is done in a controlled medical setting, ensuring proper dosage and monitoring of the patient[1][2].

Clinical Trials for KAN-101

KAN-101 is currently being studied in clinical trials to assess its safety, effectiveness, and how well patients tolerate it. There are two main clinical trials mentioned in the provided information:

  1. Phase 1 Study (NCT04248855): This initial study, also called the “Assessment of KAN-101 in Celiac Disease (ACeD)” trial, is designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease who are on a gluten-free diet. It consists of two parts:
    • Part A: A single-dose study where patients receive one dose of KAN-101.
    • Part B: A multiple-dose study where patients receive three doses of either KAN-101 or a placebo (a substance with no active medication).
    This study helps researchers understand how the body responds to different doses of KAN-101 and identify any potential side effects[1].
  2. Phase 2a Study (NCT06001177): This more advanced study aims to evaluate the efficacy (how well it works), safety, and tolerability of KAN-101 in people with celiac disease. It involves approximately 52 participants who will be randomly assigned to receive either KAN-101 or a placebo. This study will help determine if KAN-101 can protect against the harmful effects of gluten exposure in the small intestine[2].

Safety and Efficacy of KAN-101

The clinical trials are designed to assess various aspects of KAN-101’s safety and effectiveness. Some key points being studied include:

  • Safety: Researchers are monitoring the incidence and severity of treatment-emergent adverse events (TEAEs). These are any unfavorable medical occurrences that happen during the study period. The severity is assessed using a standardized scale called the Common Terminology Criteria for Adverse Events (CTCAE)[1][2].
  • Efficacy: The Phase 2a study is examining whether KAN-101 can protect against gluten-induced changes in the small intestine. This is measured by looking at changes in the ratio of villous height to crypt depth (Vh:Cd) in the small intestine after a gluten challenge[2].
  • Immune Response: The study is also looking at changes in immune responses, such as the interleukin-2 (IL-2) response and the density of intraepithelial lymphocytes (IELs) in the small intestine[2].
  • Drug Concentration: Researchers are measuring how KAN-101 behaves in the body by looking at its concentration in the blood over time. This helps determine how the body processes the drug[2].

Future Prospects for KAN-101

While KAN-101 is still in the clinical trial phase, it represents a potential new treatment option for people with celiac disease. If successful, it could offer a way to protect against the harmful effects of accidental gluten exposure, which is a significant concern for many people with celiac disease who follow a gluten-free diet.

The ongoing studies will provide crucial information about the safety and effectiveness of KAN-101. If the results are positive, it could lead to further studies and potentially become an approved treatment for celiac disease in the future. However, it’s important to note that drug development is a long and complex process, and more research is needed before KAN-101 could become widely available[1][2].

Aspect Details
Drug Name KAN-101
Condition Studied Celiac Disease (CeD)
Administration Method Intravenous (IV) infusion
Trial Phases Phase 1 and Phase 2a
Study Design Randomized, double-blind, placebo-controlled
Primary Outcomes Changes in small intestine structure (Vh:Cd ratio), Safety and tolerability
Secondary Outcomes Immune responses (IL-2, IEL density), Pharmacokinetics, Antidrug antibodies
Participant Criteria Adults (≥18 years) with Celiac Disease on a gluten-free diet

FAQ

  • What is KAN-101? KAN-101 is an investigational drug being studied as a potential treatment for Celiac Disease. It is administered through intravenous infusion and is being tested to see if it can protect against the harmful effects of gluten exposure in people with Celiac Disease.
  • How is KAN-101 being tested in clinical trials? KAN-101 is being tested in Phase 1 and Phase 2a clinical trials. These studies involve both single and multiple dose administrations of the drug. Some trials compare KAN-101 to a placebo to evaluate its effectiveness and safety.
  • What are the main goals of the KAN-101 clinical trials? The main goals are to evaluate the safety, tolerability, and efficacy of KAN-101 in patients with Celiac Disease. Researchers are particularly interested in whether KAN-101 can protect against gluten-induced changes in the small intestine and improve overall outcomes for patients.
  • Who can participate in these clinical trials? The trials are designed for adult patients (18 years and older) with Celiac Disease who are currently following a gluten-free diet. Specific inclusion and exclusion criteria may vary between different studies.
  • What kind of measurements are being taken in these trials? The trials measure various outcomes, including changes in small intestine tissue structure, immune responses, and the presence of the drug in the blood. They also closely monitor for any side effects or adverse events that may occur during treatment.

Ongoing Clinical Trials on Kan-101

  • Study on the Effects of KAN-101 and Sodium Chloride in Adults with Celiac Disease

    Not recruiting

    1 1
    Investigated drugs:
    Finland Germany Ireland The Netherlands Poland

Glossary

  • Celiac Disease (CeD): An autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. It affects people who are genetically predisposed to the condition.
  • Gluten-free diet (GFD): A diet that strictly excludes gluten, a protein found in wheat, barley, and rye. It is the primary treatment for Celiac Disease.
  • Intravenous (IV) infusion: A method of delivering medications directly into the bloodstream through a vein, typically using a needle or catheter.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect. It's used as a control in clinical trials to compare against the active treatment.
  • Vh:Cd ratio: The ratio of villous height to crypt depth in the small intestine. It's a measure used to assess the health and structure of the intestinal lining.
  • Intraepithelial lymphocyte (IEL): A type of white blood cell found in the lining of the intestines. Increased numbers of IELs can indicate inflammation or damage to the intestinal lining.
  • Interleukin-2 (IL-2): A type of protein that regulates the activities of white blood cells that are responsible for immunity. It's often measured to assess immune system activity.
  • Antidrug antibody (ADA): Antibodies that the body produces against a therapeutic drug. The presence of ADAs can affect how well a drug works or cause side effects.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Common Terminology Criteria for Adverse Events (CTCAE): A standardized set of criteria for the classification of adverse side effects of drugs used in cancer therapy and other medical treatments.

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