Not recruiting

Study of Anifrolumab for Adults with Moderate-to-Severe Systemic Lupus Erythematosus

Fast replyInvestigationalNo placebo

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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 effects of a treatment for Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues in the body, causing inflammation and damage to various organs. The treatment being tested is called Anifrolumab, which is administered as a solution for injection under the skin. Anifrolumab is being compared to a placebo to evaluate its effectiveness and safety in reducing the overall disease activity in adults with moderate-to-severe SLE.

The purpose of the study is to assess how well Anifrolumab works in managing the symptoms of SLE. Participants in the study will receive either Anifrolumab or a placebo through a prefilled syringe designed for subcutaneous use, meaning it is injected just under the skin. The study will follow participants over a period to monitor their response to the treatment and any changes in their condition.

Throughout the study, researchers will observe the participants to determine if Anifrolumab can help reduce the activity of SLE and improve the patients' quality of life. The study aims to provide valuable information on the potential benefits of Anifrolumab for individuals living with this challenging autoimmune disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of moderate-to-severe systemic lupus erythematosus (SLE) and certain health assessments.
Women of childbearing potential must have a negative pregnancy test before starting the study treatment.
Step 2
Initial assessment
An initial assessment is conducted to evaluate disease activity using specific scoring systems. This includes the SLEDAI-2K score and BILAG-2004 assessment.
A physician's global assessment score is also recorded.
Step 3
Treatment administration
The treatment involves the administration of anifrolumab, a solution for injection, given subcutaneously.
The dosage and frequency of administration are determined by the study protocol.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring is conducted to assess the efficacy and safety of the treatment.
This includes tracking disease activity and any potential side effects.
Step 5
Evaluation of response
The primary goal is to evaluate the response to treatment using the BICLA criteria, which involves a composite assessment of disease activity.
Secondary evaluations include the proportion of patients maintaining low or reduced use of other medications and the time to disease flare.
Step 6
Completion of study
The study is expected to conclude by January 2026, with final assessments conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

14 criteria

Patients must have a diagnosis of **Systemic Lupus Erythematosus (SLE)**, which is a condition where the immune system attacks the body's own tissues, for at least 24 weeks before joining the study.
Women who can have children must have a negative pregnancy test before starting the study treatment.
Women who cannot have children must be postmenopausal (no periods for a long time) or have had surgery to prevent pregnancy, like removal of ovaries or uterus, and this should be noted in their medical records.
Women who can have children must use a very effective birth control method and a male condom from the start of the study until 16 weeks after the last dose of the study treatment, unless they are surgically sterile, have a sterile male partner, are postmenopausal for at least 12 months, or choose not to have sex.
Women who have been sexually active and have a cervix must have a normal cervical cancer screening test, like a Pap smear or HPV test, within 2 years before starting the study. If there was an abnormal result, it must be checked again to confirm eligibility.
Women under 25 who have never been sexually active or have proof of HPV vaccination might not need a cervical cancer screening test.
Patients must have a certain score on a test called **SLEDAI-2K**, which measures disease activity, with at least 4 points from clinical symptoms at the start of the study.
At the start of the study, patients must have a certain level of disease activity in at least one or two organ systems, confirmed by a review team.
Patients must have a **Physician's Global Assessment (PGA)** score of at least 1.0, which is a doctor's overall assessment of the disease, at the start of the study.
Patients must test positive for certain antibodies, which are proteins made by the immune system, at the start of the study.
Patients must be on stable treatment with medications like antimalarials, immunosuppressants, and glucocorticoids, either alone or in combination.
All fertile males who are sexually active must use a condom from the start of the study until at least 16 weeks after the last dose of the study treatment. It is strongly recommended that their female partners also use an effective birth control method during this time.
Male patients must not donate sperm during the study and for 16 weeks after the last dose of the study treatment.
Women who can have children must have a negative blood pregnancy test at the start of the study.

Who cannot join the trial?

15 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received certain medications that could affect the study results.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients who have had a recent vaccination.
Patients with a history of cancer, except for certain types of skin cancer.
Patients with a history of severe allergic reactions.
Patients with certain blood disorders.
Patients with a history of mental health conditions that are not well controlled.
Patients who have had a recent surgery.
Patients with a history of heart problems.
Patients with a history of liver or kidney disease.
Patients who are unable to comply with the study requirements.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Verified
Cracow, Poland
FutureMeds Wrocław
Verified
Wroclaw, Poland
Hospital Universitario Hm Sanchinarro
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Anifrolumab is a medication being studied for its effectiveness and safety in treating adults with systemic lupus erythematosus (SLE). It is administered through an injection under the skin. The goal of the trial is to see how well anifrolumab can reduce the overall disease activity in patients with SLE compared to those who do not receive the active medication.

Anifrolumab

What is already known about the treatment

Anifrolumab – Anifrolumab is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating moderate-to-severe systemic lupus erythematosus (SLE), a chronic autoimmune disease. The medication works by targeting and blocking a specific protein involved in the immune response, which is believed to play a role in the inflammation and symptoms associated with SLE. Anifrolumab is classified as a monoclonal antibody, a type of drug designed to interact with specific targets in the body to modify disease processes.

Investigated diseases

Systemic Lupus Erythematosus (SLE) – Systemic Lupus Erythematosus is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease is characterized by periods of illness, called flares, and periods of wellness, or remission. Symptoms can vary widely among individuals and may include fatigue, joint pain, skin rashes, and fever. Over time, SLE can lead to inflammation and damage in the affected organs. The severity and progression of the disease can differ greatly from person to person.