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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
FutureMeds Wrocław	Wroclaw	Poland

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
Hospital Del Mar	Barcelona	Spain
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Budai Irgalmasrendi Korhaz Nonprofit Kft.	Budapest	Hungary
Reumed Sp. z o.o.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Hospital Universitario Infanta Sofía	San Sebastian De Los Reyes	Spain
Synexus Bulgaria EOOD	Sofia	Bulgaria
Medical Center Excelsior OOD	Sofia	Bulgaria
Medical Center Rodopimed EOOD	Kirdzhali	Bulgaria
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet	Budapest	Hungary
Pratia S.A.	Skorzewo	Poland
University Multiprophy Hospital For Active Treatment – Plovdiv AD	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Somed Cr Sp. z o.o. sp.k.	Lodz	Poland
Staedtisches Klinikum Dresden	Dresden	Germany
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Medical Center 1 Sevlievo EOOD	Sevlievo	Bulgaria
Vital Medical Center	Veszprem	Hungary
Prywatna Praktyka Lekarska Prof Dr Hab Med Paweł Hrycaj	Poznan	Poland
Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki	Wroclaw	Poland
Meamyfvye Idnmhprfif Ccjcnwmb Sblhnxlh Svm z orpi	Warsaw	Poland
Vxya Vqrfs Mxomldr Eigulbpipzur Sxsnulykmmi Bvf	Szekesfehervar	Hungary
Srwvkhy Crcoplm Regvlpkvvipv Oiqmrndfa I Rvtcdynlhguaa W Ujnrojwd Sdb z ojyg	Ustron	Poland
Ugulgeaivw Hpupafyp Cfvvtaz	Cologne	Germany
Mswcolyb Mceuidd Auzwdbq	Pleven	Bulgaria
Hhjlejdx Vvru dlbdwsdl	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	08.06.2021
Germany	Not recruiting	08.06.2021
Hungary	Not recruiting	08.06.2021
Poland	Not recruiting	08.06.2021
Spain	Not recruiting	08.06.2021

Trial locations

Investigated drugs:

Anifrolumab

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.

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.

Trial ID:

2024-513031-24-00

Protocol code:

D3465C00001

NCT ID:

NCT04877691

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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