Evaluation of Anifrolumab Subcutaneous Treatment in Immunosuppressant‑Naïve and Biologic‑Naïve Patients with Systemic Lupus Erythematosus

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What is this study about?

The trial focuses on Systemic lupus erythematosus, a chronic autoimmune disease that can cause inflammation and damage to the skin, joints, kidneys, and other organs. Participants receive the investigational drug anifrolumab given as a subcutaneous injection of 120 mg once a week. The medication is administered under the skin using a pre‑filled syringe, and participants may continue taking antimalarial medicines and, if needed, a low dose of glucocorticoid steroid.

The purpose of the study is to assess the proportion of participants who reach DORIS remission after one year of treatment. Over a 52‑week period, participants attend regular clinic visits where the weekly injections are given, safety checks are performed, and doctors record disease activity. The study follows each participant from the start of treatment through the final visit at week 52, allowing researchers to observe how the disease responds over time.

1 initial enrollment and baseline assessment

after signing the consent form, you will attend a baseline visit where personal health information is recorded and blood samples may be taken.

the study medication, anifrolumab 120 mg solution for injection, will be prepared for weekly use.

2 first injection and start of weekly dosing

the first dose of anifrolumab 120 mg is given by a healthcare professional under the skin (subcutaneous route).

the injection schedule is set to repeat every week for a total of 52 weeks.

3 weekly injections (weeks 2‑52)

each week you will receive a 120 mg injection of anifrolumab under the skin.

the injection is administered by clinic staff or, if allowed, by you at home following written instructions.

4 interim assessment at week 28

at week 28 a study visit is performed to evaluate disease activity and to determine whether you have reached DORIS remission, a state of disease control.

blood tests and questionnaires may be completed during this visit.

5 final assessment at week 52

at week 52 a final study visit occurs to assess the primary outcome of DORIS remission after one year of treatment.

the same clinical evaluations as earlier visits are performed.

6 study completion

after the week 52 visit the study is considered complete for you.

you may discuss continued care with your regular physician.

Who Can Join the Study?

Be between 18 and 70 years old at the time you sign the consent form.
Have a diagnosis of systemic lupus erythematosus (SLE) that was confirmed by a rheumatologist (a doctor who treats joint and immune‑system diseases) for at least three months before signing the consent form.
Show a positive result on an ANA (antineuclear antibody) blood test with a titer of 1:80 or higher, or have at least one of the following antibodies detected at screening: anti‑dsDNA or anti‑Smith (anti‑Sm). (The ANA test looks for antibodies that may target the cell nucleus.)
Be taking the standard treatment regimen, which includes antimalarial medication (such as hydroxychloroquine) with or without OCS (oral corticosteroids, a type of anti‑inflammatory medication).
At the screening visit and at baseline, either have a clinical disease‑activity score called SLEDAI‑2K of 4 points or higher, or, if the score is less than 4, be on a glucocorticoid dose of at least 7.5 mg per day of prednisone (or an equivalent medication).

Who Cannot Join the Study?

Having a past or current diagnosis of a significant non‑SLE vasculitis syndrome, which means inflammation of the blood vessels unrelated to lupus.
Testing positive for hepatitis B, a viral infection that affects the liver.
Having an active hepatitis C infection, another virus that can damage the liver.
Having a current cytomegalovirus (CMV) or Epstein‑Barr virus (EBV) infection that has not completely cleared within the last 12 weeks; these are common viruses that can cause illness, especially in people with weakened immune systems.
Having had an opportunistic infection that required a hospital stay or intravenous (IV) antimicrobial treatment within the past 3 years; these infections take advantage of a weakened immune system and IV medicines are given directly into a vein.
Having a clinically significant chronic infection within 8 weeks before signing the consent form.
Having severe or recurrent Herpes Zoster (shingles), a painful rash caused by reactivation of the chicken‑pox virus.
Having a history of malignancy (cancer).
Having antiphospholipid antibody syndrome with a serious clotting (thrombotic) event or an unexplained miscarriage within the year before screening; this condition increases the risk of blood clots and pregnancy loss.
Having a history of catastrophic antiphospholipid syndrome, a saddle embolism (a large clot that blocks a main artery in the lung), or three or more consecutive unexplained pregnancy losses.
Having thoughts of suicide rated as moderate to severe in the past 6 months, any suicide attempt in the past year, or repeated suicidal behavior at any time.
Having active, severe, or unstable neuropsychiatric SLE, meaning lupus affecting the brain or nervous system.
Having active, severe kidney disease caused by lupus that cannot be controlled with the standard therapy specified in the study.
Having a history of catastrophic antiphospholipid syndrome within one year before signing the consent form.
Having a history of repeated infections that required hospitalization and IV antibiotics.
Having a known primary immunodeficiency, having had a splenectomy (removal of the spleen), any condition that makes infections more likely, or a positive test for HIV (human immunodeficiency virus) confirmed by a central laboratory.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
HIA Sainte Anne	Toulon	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hopital Beaujon	Clichy	France
Hospital Edouard Herriot	Lyon	France
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Klinikum Bad Bramstedt GmbH	Bad Bramstedt	Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Reumed Sp. z o.o.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
NZOZ Lecznica Mak Med s.c.	Nadarzyn	Poland
Prywatna Praktyka Lekarska Prof Dr Hab Med Pawel Hrycaj	Poznan	Poland
Avurkqxokx Pwsegzls Hhgallfj Dr Mudartbzp	Marseille	France
Cjbreb Hwxbjuxsyli Rpaafqat Uwaaqfkguvfwh Dk Tfauu	Tours	France
Cjln Dq Ncqwx	Vandoeuvre Les Nancy	France
Kpsahitl djk Uvzhlcboxdul Mbnsrhdu Ade	Munich	Germany
Mmcmuqqqj Iblgdfgxta Cuzdgfql Szfrlowi Svt z oryk	Warsaw	Poland
Chuucea Mbpxmoro Jtqotql Sjp z opjs	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.06.2026
Germany	Not yet recruiting	01.06.2026
Italy	Not yet recruiting	01.06.2026
Poland	Not yet recruiting	01.06.2026

Trial locations

Investigated drugs:

Anifrolumab

Anifrolumab is a medication given as a liquid that is injected under the skin. In this study it is used once a week to treat people with systemic lupus erythematosus (SLE) who have not taken other immune‑suppressing drugs or biologic medicines before. The drug works by blocking a specific part of the immune system that can cause inflammation and damage in lupus.

Antimalarial therapy (such as hydroxychloroquine) is a medicine that is often used in lupus to help control disease activity and prevent flare‑ups. In this trial participants continue to take an antimalarial, which can reduce skin and joint symptoms and help protect against long‑term organ problems.

Glucocorticoids are a type of steroid medicine that reduces inflammation quickly. Some participants in the study may be taking a low dose of a glucocorticoid along with the antimalarial. The steroid helps keep lupus symptoms under control while the new treatment is being tested.

Systemic lupus erythematosus – Systemic lupus erythematosus is an autoimmune condition where the immune system mistakenly attacks healthy tissues throughout the body. It can cause inflammation in the skin, joints, kidneys, heart, lungs, and brain. The disease often begins with mild symptoms such as fatigue, joint pain, or a rash, and may later involve more organs. Over time, the activity of the disease can fluctuate, with periods of worsening symptoms followed by quieter phases. The involvement of different organs may increase as the condition continues, leading to new symptoms as the immune attack spreads.

Trial ID:

2025-523670-17-00

Protocol code:

D3461C00040

Trial Phase:

Therapeutic confirmatory (Phase III)

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Evaluation of Anifrolumab Subcutaneous Treatment in Immunosuppressant‑Naïve and Biologic‑Naïve Patients with Systemic Lupus Erythematosus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?