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A Study of Anifrolumab for Patients with Cutaneous Lupus Erythematosus to Measure Changes in Skin and Blood Inflammation and Clinical Outcomes

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What is this trial about?

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

This study examines cutaneous lupus erythematosus, which is a condition where the immune system attacks the skin, causing rashes and other skin problems. The study uses a medication called Saphnelo, which contains the active substance anifrolumab. This medication works by affecting the immune system to reduce inflammation in the body.

The purpose of this study is to investigate how anifrolumab affects inflammatory cells, which are cells involved in the body's immune response, in the skin and blood of people with cutaneous lupus erythematosus. The study will examine changes in these cells and how genes are expressed, meaning how active certain genes are in these cells. Additionally, the study will look at how the medication affects the clinical course of the disease, which refers to how the symptoms and overall condition progress over time.

During the study, participants will receive anifrolumab through infusion, which means the medication will be given directly into a vein over a period of time. The maximum daily dose is 300 milligrams, and participants may receive up to 3900 milligrams in total over the treatment period of 48 weeks. Skin and blood samples will be collected and analyzed using various laboratory techniques to understand how the inflammatory cells change during treatment. The study will also monitor how the skin condition responds to the treatment.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase begins
Your participation in the clinical trial starts after you have completed all required screenings and have been accepted into the study.
The study involves treatment with anifrolumab, which is a medication given through infusion (a slow injection into a vein).
The product used is called Saphnelo 300 mg, which is prepared as a concentrated solution for infusion.
Step 2
Receiving anifrolumab infusions
You will receive anifrolumab through an intravenous infusion.
The infusion is administered directly into your vein over a period of time.
The specific dosage, frequency, and total duration of treatment are determined by the study protocol, which your medical team will explain to you in detail.
Step 3
Skin sample collection
During the study, skin samples will be taken from your active lupus lesions (areas of skin affected by the condition).
These samples are collected to analyze the inflammatory cells (cells involved in the body's immune response) present in your skin.
The analysis includes examining the composition of these cells and their activity at the molecular level.
Step 4
Blood sample collection
Blood samples will be taken at specified times during the study.
These samples are used to examine changes in inflammatory cells and gene expression (how your genes are being used by your cells) in your blood.
The blood tests help to understand how the medication affects your immune system.
Step 5
Clinical assessments
Your skin condition will be regularly assessed throughout the study.
The medical team will evaluate the clinical outcome, which means they will observe and document any changes in your symptoms and the appearance of your skin lesions.
These assessments help to determine how effective the treatment is for your condition.
Step 6
Ongoing monitoring during treatment
Throughout the study, your health and response to treatment will be continuously monitored.
Any side effects or changes in your condition will be recorded.
Regular follow-up visits are scheduled to ensure your safety and to collect necessary data for the study.
Step 7
Contraception requirements for females
If you are a female of childbearing potential, you must use two effective methods of contraception during the study.
One of these methods must be a barrier method (such as condoms or a diaphragm).
This requirement continues from the start of the study until 12 weeks after your final dose of the study medication.
This is necessary because the effects of the medication on pregnancy are not fully known.
Step 8
Completion of treatment phase
After you have received all scheduled infusions of anifrolumab, the active treatment phase of the study ends.
Final assessments and sample collections will be performed.
The study is expected to continue until the end of 2029, though your individual participation duration may vary.
Step 9
Follow-up period
After completing the treatment, you will enter a follow-up period.
During this time, your health and any lasting effects of the treatment will be monitored.
This follow-up is important to assess the long-term impact of the medication on your condition.

Who can join the trial?

5 criteria

You must have active skin lesions of cutaneous lupus erythematosus, which is a condition that causes skin inflammation and rashes, confirmed by examining a small sample of skin tissue under a microscope
You must be 18 years of age or older
You must be able to understand and sign a document that explains the study and your agreement to participate, called an informed consent
If you are a woman who can become pregnant, you must use two effective methods of birth control, with one being a barrier method such as condoms or a diaphragm, from the start of the study until 12 weeks after receiving the last dose of the study medicine. This requirement does not apply if you have had surgery to prevent pregnancy, such as having your tubes tied, ovaries removed, or uterus removed. Not having sexual relations is acceptable, but methods like timing your cycle or withdrawal are not acceptable
You must meet all of the following requirements related to tuberculosis, which is an infection that usually affects the lungs: you have never had active tuberculosis before joining the study, and you have never had inactive tuberculosis unless you completed the full treatment for it. If inactive tuberculosis is found during the screening process for this study, you may still be eligible if you start appropriate treatment before joining the study

Who cannot join the trial?

3 criteria

The study does not list specific reasons why patients cannot participate
General exclusion criteria will be determined by the research team based on medical history and current health condition
Patients should discuss their individual situation with the study doctor to determine if they are eligible to participate

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Anifrolumab is a medicine used to treat lupus, which is a condition where the body's immune system mistakenly attacks healthy tissues. This medication works by blocking a protein in the body that plays a role in causing inflammation. In this trial, anifrolumab is being studied to see how it affects the skin inflammation and immune cells in patients with cutaneous lupus erythematosus, which is a form of lupus that mainly affects the skin.

Anifrolumab

What is already known about the treatment

Anifrolumab – Anifrolumab is a medication given through an intravenous infusion (directly into a vein) that is used to treat lupus, specifically the form that affects the skin called cutaneous lupus erythematosus. This medicine works by blocking a protein called type I interferon receptor, which helps reduce the overactive immune response that causes inflammation and skin damage in lupus patients. It belongs to a class of drugs called monoclonal antibodies, which are specially designed proteins that target specific parts of the immune system. Anifrolumab is currently approved and used in clinical practice for treating moderate to severe lupus, and ongoing research continues to study how it affects inflammatory cells in both the skin and blood of patients.

Investigated diseases

Cutaneous Lupus Erythematosus – Cutaneous lupus erythematosus is an autoimmune disease that primarily affects the skin. The immune system mistakenly attacks healthy skin tissue, causing inflammation and damage. The disease can appear in several forms, with symptoms ranging from disc-shaped lesions to widespread rashes across sun-exposed areas. Skin changes may include redness, scaling, and scarring, particularly on the face, scalp, and other areas exposed to sunlight. The condition can occur on its own or as part of systemic lupus erythematosus, which affects multiple organs. Symptoms often worsen with sun exposure and may come and go in episodes of flare-ups and remission.