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Study on the Effects of Human Normal Immunoglobulin in Adults with Dermatomyositis

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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 disease known as Dermatomyositis, which is a condition that causes muscle weakness and skin rashes. The treatment being tested in this study is called IgPro20, also known as Hizentra, which is a type of medication made from human blood proteins called immunoglobulins. These proteins help the body fight infections and may also help reduce inflammation in conditions like dermatomyositis.

The purpose of the study is to evaluate how effective and safe IgPro20 is for adults with dermatomyositis. Participants in the study will receive either the IgPro20 treatment or a placebo. The study will last for several weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if the treatment can improve symptoms and overall health in people with dermatomyositis.

Throughout the study, participants will be assessed on their improvement using a scoring system that measures various aspects of their condition, such as muscle strength and skin symptoms. The study will also look at whether participants can reduce their use of other medications, like corticosteroids, which are often used to manage symptoms of dermatomyositis. The results will help determine if IgPro20 is a beneficial treatment option for this condition.

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 dermatomyositis, including age and disease characteristics.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of Hizentra, a solution for subcutaneous injection. This medication contains human normal immunoglobulin and is used to manage symptoms of dermatomyositis.

    The dosage and frequency of administration are determined by the study protocol and are tailored to individual needs.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular assessments are conducted to evaluate the effectiveness and safety of the treatment. These assessments include measuring the Total Improvement Score (TIS) at specified weeks (17, 21, and 25).

    Additional evaluations include muscle strength tests and skin condition assessments to monitor changes from the baseline.

  4. Step 4

    Completion of treatment phase

    The treatment phase lasts for 24 weeks, during which the response to the medication is closely monitored.

    Participants are expected to complete the treatment phase without the use of additional corticosteroid treatments unless necessary.

  5. Step 5

    Follow-up and final assessments

    After completing the treatment phase, follow-up assessments are conducted to gather data on long-term effects and any changes in the condition.

    The study aims to collect data up to 53 weeks to evaluate sustained improvements and any potential adverse effects.

Who can join the trial?

5 criteria

  • Participants must be **male or female** and **18 years of age or older**.
  • Participants must have a diagnosis of **idiopathic inflammatory myopathies**, which are muscle diseases with unknown causes. This includes confirmation of a **dermatomyositis (DM) rash or manifestation**.
  • The disease must be active, shown by the presence of a **DM rash or other signs of the disease**.
  • The severity of the disease must be measured by a **Physician global visual analog scale (VAS)**, which is a tool doctors use to rate the severity of the disease. The score must be at least **2.0 cm on a 10 cm scale**.
  • Participants must have a **Manual Muscle Testing (MMT-8) score of 142 or less**, which is a test to measure muscle strength, or a **Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score of 14 or more**, which measures skin involvement in the disease.

Who cannot join the trial?

4 criteria

  • Having a different condition than Dermatomyositis, which is a specific muscle and skin condition.
  • Being outside the specified age range for the study.
  • Belonging to a group that is not included in the study.
  • Being part of a vulnerable population that the study does not include.
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Investigated drugs

IgPro20 (Hizentra®) is a subcutaneous immunoglobulin used in this study to treat adults with dermatomyositis, a condition that causes muscle weakness and skin rashes. The medication is designed to help improve the symptoms of dermatomyositis by providing the body with antibodies that can help modulate the immune system. The study aims to evaluate how effective and safe this treatment is for patients with this condition.

What is already known about the treatment

IgPro20 (Hizentra®) – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating dermatomyositis, a condition characterized by muscle inflammation and skin rash. The main therapeutic indication for IgPro20 is to improve symptoms in adults with dermatomyositis. At the molecular level, it works by providing immunoglobulins, which are antibodies that help modulate the immune system and reduce inflammation. IgPro20 is classified as an immunoglobulin therapy, which is used to support the immune system in various conditions.

Investigated diseases

Dermatomyositis – Dermatomyositis is an inflammatory disease characterized by muscle weakness and a distinctive skin rash. It primarily affects the muscles and skin, leading to muscle inflammation and damage. The skin rash often appears as a reddish or purplish discoloration, typically on the face, knuckles, and other areas exposed to sunlight. Muscle weakness usually begins in the muscles closest to the trunk, such as those in the hips, thighs, shoulders, and neck. Over time, the weakness can progress, making it difficult to perform everyday activities. The exact cause of dermatomyositis is unknown, but it is believed to involve an autoimmune response where the body's immune system mistakenly attacks its own tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508293-28-00Estimated enrolment126 patientsSponsorCSL Behring LLC

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