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Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and effectiveness of a treatment for several chronic inflammatory diseases. The diseases being studied include Mucous Membrane Pemphigoid, Primary Sclerosing Cholangitis, Pemphigus Vulgaris, and Polymyositis/Dermatomyositis. The treatment being tested is a low-dose form of Interleukin-2, also known by its code name IL-2. This medication is administered as a solution for injection or infusion. The study will also use Glucose as part of the trial.

The purpose of this study is to evaluate the safety and the relationship between the body's immune response and the clinical outcomes when using low-dose IL-2 therapy in patients with these diseases. Participants will receive the treatment over a period of eight weeks. The study is designed to be randomized, meaning participants will be randomly assigned to different groups, and double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or a placebo. This helps ensure the results are unbiased.

Throughout the study, researchers will monitor the participants' immune responses and any changes in their disease symptoms. The goal is to understand how the treatment affects the immune system and whether it leads to improvements in the conditions being studied. The trial will help determine if low-dose IL-2 therapy is a safe and effective option for managing these chronic inflammatory diseases.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to the condition being studied, such as disease activity levels and age range.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements for disease activity. This includes evaluating specific indices or plasma levels relevant to the condition.

  3. Step 3

    Treatment phase

    During the treatment phase, the medication aldesleukin is administered subcutaneously. This involves injecting the medication under the skin.

    The treatment is given in low doses as part of the study to evaluate its effects on the immune system and disease symptoms.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the body's response to the treatment. This includes measuring specific immune cells and disease activity indices.

    Follow-up assessments occur periodically to track changes in disease symptoms and overall health.

  5. Step 5

    Final assessment

    A final assessment is performed at the end of the treatment period, which is approximately 57 days from the start.

    This assessment evaluates the overall response to the treatment, comparing initial and final disease activity measures.

Who can join the trial?

6 criteria

  • Participants must have one of the following conditions: Pemphigus vulgaris or foliaceus, Mucous Membrane Pemphigoid, Polymyositis or Dermatomyositis, or Primary Sclerosing Cholangitis.
  • For those with Pemphigus vulgaris or foliaceus, the disease activity should be mild to moderate, with a score between 6 and 45 on a specific scale called PDAI.
  • For those with Mucous Membrane Pemphigoid, the disease activity should also be mild to moderate, with a score between 6 and 45 on a scale called MMPDAI.
  • For those with Polymyositis or Dermatomyositis, they should have higher than normal levels of a muscle enzyme called creatine kinase, between 300 and 3000 units per liter. Having other rheumatic diseases at the same time is allowed.
  • For those with Primary Sclerosing Cholangitis, they should have higher than normal levels of an enzyme called alkaline phosphatase, at least 1.5 times above the normal limit. Having inflammatory bowel diseases at the same time is allowed.
  • Participants must be between the ages of 18 and 80 years old.

Who cannot join the trial?

11 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to similar treatments are excluded.
  • Patients with active infections that require treatment are not eligible.
  • People with a history of cancer within the last five years, except for certain skin cancers, cannot join.
  • Individuals with significant heart problems, such as heart failure, are excluded.
  • Patients with uncontrolled high blood pressure are not eligible.
  • People with severe liver or kidney disease cannot participate.
  • Individuals who have received another investigational drug within the last 30 days are excluded.
  • Patients with a history of drug or alcohol abuse within the past year are not eligible.
  • Individuals with certain autoimmune diseases not being studied in this trial are excluded.
  • Patients who are unable to comply with the study procedures are not eligible.
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Investigated drugs

Interleukin-2 (IL-2) is a medication being studied for its potential to help manage chronic inflammatory diseases. In this trial, it is used in low doses to see if it can safely increase the number of regulatory T cells (Tregs) in the body. These Tregs are important because they help control the immune system and reduce inflammation. The trial is looking at how well this medication works in people with conditions like Pemphigus vulgaris, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis.

What is already known about the treatment

Interleukin-2 (IL-2) – This medication is administered as a low-dose injection, typically under the skin. It is currently being studied in clinical trials for its potential benefits in treating chronic inflammatory diseases such as Mucous Membrane Pemphigoid, Primary Sclerosing Cholangitis, Pemphigus vulgaris/foliaceus, and Polymyositis/Dermatomyositis. The main therapeutic indication is to modulate the immune system by increasing the number of regulatory T cells, which help control inflammation. At the molecular level, IL-2 works by binding to specific receptors on T cells, promoting their growth and activity. It is classified as an immunomodulatory agent.

Investigated diseases

  • Mucous Membrane Pemphigoid

    This is a chronic autoimmune disorder characterized by blistering lesions primarily affecting the mucous membranes, such as the mouth, eyes, and throat. The disease progresses with the formation of blisters that can lead to scarring, particularly in the eyes, potentially causing vision problems. The blisters are caused by the immune system mistakenly attacking the tissue that connects the outer layer of skin to the underlying layer.

  • Primary Sclerosing Cholangitis

    This is a chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to liver damage over time. The disease progresses as the bile ducts become narrowed and blocked, causing bile to accumulate in the liver, leading to liver cell damage. Symptoms may include fatigue, itching, and jaundice, but some individuals may remain asymptomatic for years.

  • Pemphigus Vulgaris

    This is an autoimmune disorder that causes painful blisters and erosions on the skin and mucous membranes. The disease progresses as the immune system attacks the proteins that hold skin cells together, leading to the separation of skin layers and blister formation. Blisters can occur anywhere on the body but are most common in the mouth and on the skin.

  • Pemphigus Foliaceus

    This is a milder form of pemphigus that primarily affects the skin, causing superficial blisters and crusty sores. The disease progresses as the immune system attacks the outermost layer of skin, leading to blistering and scaling. Unlike pemphigus vulgaris, it rarely affects the mucous membranes.

  • Polymyositis

    This is an inflammatory muscle disease that causes muscle weakness, primarily affecting the muscles closest to the trunk of the body. The disease progresses with increasing muscle weakness, which can lead to difficulty in performing everyday activities such as climbing stairs or lifting objects. It is believed to be an autoimmune condition where the immune system attacks muscle tissue.

  • Dermatomyositis

    This is an inflammatory disease marked by muscle weakness and a distinctive skin rash. The disease progresses with muscle weakness similar to polymyositis, but it also includes a rash that can appear on the face, knuckles, and other areas. The rash is often the first sign of the disease and can be accompanied by muscle pain and fatigue.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510297-14-00Protocol codeEXC2167-5Estimated enrolment112 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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