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

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Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Cjjbgf Hxjeipvxewq Ugmhvnevjaaac Dd Lg Rreylqq	St Denis	France
Hjo Sxcrvt Aies	Toulon	France
Afakpop Orbmdcsqgocgyptvvbkorabsy Ptayjdfnbnc Gd Rqbqiwsmoqgu Madfq Dx Chgypfw	Catania	Italy
Umyvfgqcswnpyywervzme Rofcnvrxxc Ahd	Regensburg	Germany
Ffshgqxcsg Irvtq Cn Gqspde Oegwmzbp Mdhkavpu Pqecchdwkcy	Milan	Italy
Acezcmemus Pwfjlnzl Htcijmpj Dt Mhnrlhfdc	Marseille	France
Cxbdvx Hempkveiojs Rjuganta Uizfazeieouhk Dc Tqran	Tours	France
Kudvwhhr dwd Uxudipkzawpb Mypqbcty Aew	Munich	Germany
Aeqvtyf Sttdlojlt Utsxnolbhhdjp Fyhcgx Coxdtdtu	Udine	Italy
Hjwrpfqg Eybjdjt Hkfvnzj	Lyon	France
Utdvqvcrbwvyndaqk Dtqxi Sjpgz Dn Fmwfyob	Ferrara	Italy
Kupdrnbs Bja Bujyvfrwp Grob	Bad Bramstedt	Germany
Mcovfpyte Ivrhbxvwgc Czszpqhq Skqhbecv Srn z oijj	Warsaw	Poland
Nwxwplyg Iddokiqd Gconjbkal Ribxbrokhklx I Rknseudytnqbf Ib Pgihu Dq Hdgq Mdij Ebkukqjm Rssiqlo	Warsaw	Poland
Crwnjiw Mswkaqct Jasktov Sog z olyo	Warsaw	Poland
Smfytjbfmac Pebhmjkmc Zpqryz Oaemdy Ztpvcyytjo Sxpyvdq Utzkrkjbizwle W Kgxizoih	Cracow	Poland
Rlmaer Sog z ohmy	Lublin	Poland
Tbukn Pejoswzvnjc Nhmvapebwzo Cjgnmnj Mcmiluec Swt z oorm	Nowa Sol	Poland
Nimx Ldlgwctw Mfk Mjh slcy	Nadarzyn	Poland
Pzilhnka Pldfoclg Lyvlagdo Pmij Dw Hzy Mbc Pznhq Hjbqjg	Poznan	Poland
Htalqoew Vgob dofjlmsz	Barcelona	Spain
Fygtgixat Pxcj Lz Iscaxodeezulq Byllxglva Dek Hkeaeuws Uxiufdqulftjs Lw Pat	Madrid	Spain
Hyqxmoge Dy Gydpnbqw Uxukxrjd	Galdakao	Spain
Axsxtho Onguqrmoelm dx Potzvv	Padua	Italy
Mbi Pfbibyp Sgp z ocub	Poznan	Poland
Seqsu Cy Suk z ovrh skqdi	Lodz	Poland
Pztrkxy Stz z obms	Katowice	Poland
Uxaajundfl Dznxz Skbnx Dy Rals Ln Satptpol	Rome	Italy
Uafvwwobup Dsdtk Siosh Dp Badized	Brescia	Italy
Aqyt Cfvqwi Svsujpaftibqn Onhegibbot Tvuqkklqagbwnj Grqwzxc Pwnj Ciw	Milan	Italy
Twknneaf Shf z ojwx	Poznan	Poland
Aafjefl Omyeysojmkh Utruvbiqnuzjl Phxdvw	Pisa	Italy
Cfsvym Huxrodjyrkk Uvcphklpwtigb Dl Lf Roptskq	Saint Pierre	France
Pquh Thova Hpbxjtli Uquoihuhaasd	Sabadell	Spain
Hzdphbgw Cjltxt Dg Bwobwgfwz	Barcelona	Spain
Hqsezdmi Uzqjmkzaldsgs Vlnfxl Di Vuagd	Sevilla	Spain
Hxwugpyt Uctdlcylorjds Ideliqs Svpyf	San Sebastian De Los Reyes	Spain
Cvme Ds Nrewk	Vandoeuvre Les Nancy	France
Pnymns Snqg	Skorzewo	Poland

Trial status

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