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Study of Anifrolumab for Children and Teens with Moderate to Severe Lupus

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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 a disease called Systemic Lupus Erythematosus (SLE), which is a condition where the immune system mistakenly attacks healthy tissues in the body. The study is specifically looking at children and adolescents aged 5 to under 18 years who have moderate to severe active SLE. The treatment being tested is called Anifrolumab, also known by its code name MEDI-546. Anifrolumab is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to determine the right dose of Anifrolumab for young participants and to ensure that it is safe and effective for them. Participants in the study will receive either Anifrolumab or a placebo, which is a substance that looks like the treatment but does not contain the active ingredient. The study will take place over a period of time, during which participants will receive regular infusions and be monitored for any changes in their condition and overall health.

Throughout the study, researchers will collect information on how the body processes Anifrolumab and how it affects the symptoms of SLE. This includes looking at how well the treatment works in reducing disease activity and any potential side effects. The study aims to provide valuable insights into the use of Anifrolumab for treating SLE in children and adolescents, contributing to better management of this challenging condition.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
You will receive either anifrolumab (300 mg) or a placebo (a substance with no active medicine).
The anifrolumab or placebo is given through an intravenous infusion, which means the medicine is delivered directly into a vein.
Step 2
Monitoring and evaluation
During the study, blood samples are collected to check the concentration of the medicine in the blood and to monitor how the body reacts to the treatment.
The effectiveness and safety of the treatment are measured over a period of 52 weeks.
Step 3
Assessment of disease activity
The activity of lupus is checked using specific medical scales to see if there is an improvement in symptoms or if there is a flare, which is a sudden worsening of the condition.
Changes in antibody levels and complement levels (proteins in the blood that are part of the immune system) are also monitored throughout the 52 weeks.

Who can join the trial?

14 criteria

The participant must be between 5 and 17 years old at the time of signing the consent forms.
A parent, caregiver, or legal representative must provide informed consent, which is a signed agreement to participate in the study after understanding all its details, and the participant must provide assent, which is the child's own agreement to join.
The participant must have had a diagnosis of Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease, for at least 3 months.
The participant must have moderate to severe active SLE, which is measured by specific medical scores like SLEDAI-2K, BILAG-2004, and PGA to ensure the disease is currently active and affecting multiple parts of the body.
The participant must test positive for ANA (Antinuclear Antibody), which is a type of auto-antibody (an antibody that mistakenly attacks the body's own healthy tissues) at a specific level in the blood.
The participant must weigh at least 15 kg.
The participant must not have any signs of active Tuberculosis (TB) and must pass a specific blood test called an IGRA to check for latent TB (a form of TB where the bacteria are in the body but are inactive and not causing illness).
If a participant has latent TB, they must complete the required medical evaluation and any necessary treatment before starting the study.
All screening steps must be finished within 30 days of signing the consent forms.
The participant must be on a stable Standard of Care (SoC), which means the regular medical treatment they are already receiving for their condition.
If taking prednisone (a steroid used to reduce inflammation), the dose must have been stable for at least 2 weeks.
If taking antimalarials (medicines often used for lupus) or immunosuppressants (medicines that lower the immune system's activity), these must have been started at least 12 weeks before signing the consent and the dose must have been stable for at least 8 weeks.
Male participants who are sexually active must use a condom from the start of the study until 16 weeks after the last dose, and doctors will use Tanner staging (a method to track physical development and maturity) to assess fertility.
Female participants who are capable of having children must have a negative pregnancy test (blood and urine) and must use a highly effective method of contraception (birth control) along with a condom from the start of the study until 16 weeks after the last dose.

Who cannot join the trial?

34 criteria

People with a known diagnosis of interferonopathy, which is a rare disease caused by the body's immune system being overactive due to a protein called interferon.
Women who are breastfeeding, pregnant, or planning to become pregnant or start breastfeeding during the study or up to 16 weeks after the last dose.
Women who have had a miscarriage, stillbirth, or live birth within 4 weeks of joining the study.
Anyone with a history of severe COVID-19, such as requiring intensive care or a breathing machine, or anyone with lasting health problems from COVID-19.
Anyone who has had a mild or suspected COVID-19 infection in the 2 weeks before starting the study.
People with a history of alcohol, drug, or chemical abuse.
Anyone who has had major surgery in the last 8 weeks or has a major surgery planned during the study.
People with an active hepatitis B infection, which is a virus that attacks the liver.
People with severe neuropsychiatric SLE, which means the disease is affecting the brain or nervous system, causing issues like seizures, confusion, or problems with movement.
People with severe kidney disease caused by SLE that is not being managed well by standard treatments.
People who have had catastrophic APS, a rare and serious condition where blood clots cause widespread damage to organs, within the last year.
Anyone who has taken steroids (medicines used to reduce swelling and immune activity) by mouth or by injection for more than 2 weeks in the last 6 months for a disease other than SLE.
People who have received a live vaccine (a type of vaccine that uses a weakened version of a germ) in the last 8 weeks.
Anyone with a significant health condition that the doctor believes makes participation unsafe or difficult.
People who have had frequent infections that required hospital stays or IV antibiotics (medicine given through a vein) 3 or more times in the last year.
Anyone who has previously taken anifrolumab, the medicine being studied.
People with an active hepatitis C infection, which is another virus that affects the liver.
Anyone with a recent or active case of shingles (a painful skin rash caused by the chickenpox virus) that has not fully cleared in the last 12 weeks.
People with recent infections from the cytomegalovirus or Epstein-Barr virus that have not fully cleared in the last 12 weeks.
Anyone who has had an opportunistic infection (an infection that occurs more easily in people with weakened immune systems) requiring hospital or vein-based medicine in the last 3 years.
People with certain chronic infections (long-lasting infections) or those who have recently needed antibiotics or antivirals (medicines to fight viruses).
People with a history of cancer, except for certain common, non-dangerous skin cancers that were successfully treated.
Anyone with a known allergy to the ingredients in the study medicine or to monoclonal antibodies (lab-made proteins used to treat diseases).
People with vasculitis (inflammation of the blood vessels) that is not caused by SLE.
Anyone who has changed how they take methotrexate (a medicine used to treat SLE) in the last 8 weeks.
People who have received steroid injections into a joint or through a vein in the last 2 weeks.
Anyone who has used biologic agents (targeted medicines) or investigational drugs (medicines being tested in other studies) recently.
People who have received a blood transfusion or blood products (other than albumin, a protein in the blood) in the last 4 weeks.
People with a primary immunodeficiency (a condition where the immune system is naturally weak), a history of having their spleen removed, or an HIV infection.
People whose blood tests show abnormal levels of liver enzymes, kidney function, blood clotting cells, or hemoglobin (the part of the blood that carries oxygen).
Anyone with significant abnormalities on an ECG, which is a test that checks the electrical activity of the heart.
Participants aged 11 or older who have a history of suicidal thoughts or behaviors in recent months or years.
People currently enrolled in another medical study testing a new medicine.
People who work on the study or are immediate family members of the people running the study.

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Verified sites

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

Asklepios Klinik Sankt Augustin GmbH
Verified
Sankt Augustin, Germany
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

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Investigated drugs

Saphnelo is a medication given through a vein as an infusion. It is being tested to see how well it works and how safe it is for children and teenagers with moderate to severe systemic lupus erythematosus (an autoimmune disease). It works by targeting specific parts of the immune system to help control the disease.

Anifrolumab

What is already known about the treatment

Anifrolumab - This medication is administered as an intravenous infusion, meaning it is delivered directly into a vein through a tube. It is an approved biological therapy used primarily to treat moderate to severe systemic lupus erythematosus, a condition where the immune system attacks the body's own tissues. It works by specifically targeting and blocking a part of the body's signaling system called the type I interferon receptor, which helps reduce the harmful inflammation caused by the disease. This drug is classified as a monoclonal antibody that helps calm an overactive immune response.

Investigated diseases

Systemic lupus erythematosus - This is a chronic autoimmune disease where the body's immune system mistakenly attacks its own healthy tissues and organs. It can affect various parts of the body, including the skin, joints, kidneys, blood cells, brain, heart, and lungs. The condition is characterized by periods of high disease activity followed by periods of relative calm. During active stages, inflammation can cause damage to multiple organ systems. The disease can progress differently in every individual, sometimes involving widespread systemic inflammation.