New lupus drug aims to help patients stop steroids

NCT ID NCT07430306

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This study tests a medicine called anifrolumab for people with lupus who have not taken strong immune-suppressing drugs before. The goal is to see if the drug can help patients reach remission and reduce or stop their steroid use. About 245 adults will receive weekly injections for 52 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 245 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or females aged 18 to 70 years of age. 2. Participants who have a diagnosis of SLE confirmed by a rheumatologist. 3. ANA-positive per the Central Lab at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm) 4. Must be on the standard therapy regimen: antimalarials with or without OCSs 5. Must have at screening and baseline: 1. Clinical SLEDAI-2K ≥ 4 points OR 2. Clinical SLEDAI-2K \< 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent) 6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \[TB\]) or previous TB 7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE). 8. No medical history or signs or symptoms of active TB prior to or during Screening. 9. Body weight ≥ 40.0 kg 10. Negative pregnancy test for females during screening 11. Normal HPV test result within 2 years prior to Week 0 (Day 1). 12. Willing and able to participate in all required study evaluations and procedures including completion of PROs. 13. Willing to not use any other forms of experimental treatment during the study. Exclusion Criteria: 1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome. 2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \[INR\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE. 3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded. 4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism. 5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses. 6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening. 7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient. 8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient. 9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS). 10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks). 11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening. 12. Confirmed positive test for hepatitis B. 13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF. 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1). 15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed). 16. Severe HZ or recurrent HZ. 17. Malignancy. History of cancer, apart from: (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1). (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1). 18. Received any SLE-related therapies other than antimalarials and GCs. 19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy. 20. History of an anaphylactic reaction to human proteins or mAbs. 21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF. 22. Blood transfusion or receipt of blood products except albumin. 23. Received more than 2 investigational products for the SLE since time of diagnosis. 24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater. 25. Concurrent enrollment in another clinical study with a study intervention. 26. Subjects with any abnormal lab result as specified in the protocol. 27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.). 28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease. 29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma). 30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk. 31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention. 32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF. 33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1). 34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

106 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Research Site
WITHDRAWN

Anniston, Alabama, 36207, United States
Research Site
NOT_YET_RECRUITING

Birmingham, Alabama, 35233, United States
Research Site
NOT_YET_RECRUITING

Phoenix, Arizona, 85032, United States
Research Site
NOT_YET_RECRUITING

Tucson, Arizona, 85748, United States
Research Site
NOT_YET_RECRUITING

Fontana, California, 92335, United States
Research Site
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
Research Site
RECRUITING

La Palma, California, 90623, United States
Research Site
RECRUITING

Menifee, California, 92586, United States
Research Site
RECRUITING

San Leandro, California, 94578, United States
Research Site
RECRUITING

Temecula, California, 92592, United States
Research Site
NOT_YET_RECRUITING

Brandon, Florida, 33511, United States
Research Site
NOT_YET_RECRUITING

Miami, Florida, 33136, United States
Research Site
RECRUITING

Miami, Florida, 33145, United States
Research Site
SUSPENDED

Miami, Florida, 33180, United States
Research Site
RECRUITING

Willowbrook, Illinois, 60527, United States
Research Site
RECRUITING

New Albany, Indiana, 47150, United States
Research Site
NOT_YET_RECRUITING

Lake Charles, Louisiana, 70605, United States
Research Site
NOT_YET_RECRUITING

Silver Spring, Maryland, 20904, United States
Research Site
NOT_YET_RECRUITING

Kansas City, Missouri, 64151, United States
Research Site
NOT_YET_RECRUITING

West Long Branch, New Jersey, 07764, United States
Research Site
NOT_YET_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Research Site
RECRUITING

Oklahoma City, Oklahoma, 73116, United States
Research Site
NOT_YET_RECRUITING

Memphis, Tennessee, 38104, United States
Research Site
RECRUITING

Memphis, Tennessee, 38119, United States
Research Site
NOT_YET_RECRUITING

Austin, Texas, 78745, United States
Research Site
RECRUITING

Baytown, Texas, 77521, United States
Research Site
RECRUITING

Colleyville, Texas, 76034, United States
Research Site
RECRUITING

Edinburg, Texas, 78550, United States
Research Site
NOT_YET_RECRUITING

Houston, Texas, 77054, United States
Research Site
RECRUITING

Sugar Land, Texas, 77479, United States
Research Site
RECRUITING

Spokane, Washington, 99204, United States
Research Site
NOT_YET_RECRUITING

Calgary, Alberta, T2T 5C7, Canada
Research Site
NOT_YET_RECRUITING

Richmond, British Columbia, V6Z 1Y6, Canada
Research Site
NOT_YET_RECRUITING

Winnipeg, Manitoba, R3A 1M4, Canada
Research Site
NOT_YET_RECRUITING

Hamilton, Ontario, L8N 3Z5, Canada
Research Site
NOT_YET_RECRUITING

Toronto, M5T 2S8, Canada
Research Site
NOT_YET_RECRUITING

Clermont-Ferrand, 63000, France
Research Site
NOT_YET_RECRUITING

Lyon, 69437, France
Research Site
NOT_YET_RECRUITING

Marseille, 13385, France
Research Site
NOT_YET_RECRUITING

Paris, 75012, France
Research Site
NOT_YET_RECRUITING

Paris, 75013, France
Research Site
NOT_YET_RECRUITING

Pessac, 33604, France
Research Site
NOT_YET_RECRUITING

Saint-Denis, 97405, France
Research Site
NOT_YET_RECRUITING

Saint-Pierre, 97448, France
Research Site
NOT_YET_RECRUITING

Toulon, 83800, Cedex, France
Research Site
NOT_YET_RECRUITING

Tours, 37044, France
Research Site
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, 54511, France
Research Site
NOT_YET_RECRUITING

Bad Abbach, 93077, Germany
Research Site
NOT_YET_RECRUITING

Hamburg, 22763, Germany
Research Site
NOT_YET_RECRUITING

Mainz, 55131, Germany
Research Site
NOT_YET_RECRUITING

München, 80336, Germany
Research Site
NOT_YET_RECRUITING

Brescia, 25123, Italy
Research Site
NOT_YET_RECRUITING

Catania, 95123, Italy
Research Site
NOT_YET_RECRUITING

Ferrara, 44121, Italy
Research Site
NOT_YET_RECRUITING

Florence, 50141, Italy
Research Site
SUSPENDED

Milan, 20122, Italy
Research Site
NOT_YET_RECRUITING

Milan, 20122, Italy
Research Site
NOT_YET_RECRUITING

Padova, 35128, Italy
Research Site
NOT_YET_RECRUITING

Pisa, 56124, Italy
Research Site
NOT_YET_RECRUITING

Roma, 00161, Italy
Research Site
SUSPENDED

Roma, 00168, Italy
Research Site
NOT_YET_RECRUITING

Rozzano, 20089, Italy
Research Site
NOT_YET_RECRUITING

Udine, 33100, Italy
Research Site
NOT_YET_RECRUITING

Culiacán, 80000, Mexico
Research Site
NOT_YET_RECRUITING

Durango, 34080, Mexico
Research Site
NOT_YET_RECRUITING

Guadalajara, 44160, Mexico
Research Site
NOT_YET_RECRUITING

Guadalajara, 44650, Mexico
Research Site
SUSPENDED

Guadalajara, 44690, Mexico
Research Site
NOT_YET_RECRUITING

Mérida, 97133, Mexico
Research Site
NOT_YET_RECRUITING

México, 03100, Mexico
Research Site
NOT_YET_RECRUITING

México, 14080, Mexico
Research Site
NOT_YET_RECRUITING

Bydgoszcz, 85-065, Poland
Research Site
NOT_YET_RECRUITING

Częstochowa, 42-217, Poland
Research Site
NOT_YET_RECRUITING

Katowice, 40-611, Poland
Research Site
NOT_YET_RECRUITING

Krakow, 30-688, Poland
Research Site
NOT_YET_RECRUITING

Lodz, 90-368, Poland
Research Site
NOT_YET_RECRUITING

Lublin, 20-607, Poland
Research Site
RECRUITING

Nadarzyn, 05-830, Poland
Research Site
NOT_YET_RECRUITING

Nowa Sól, 67-100, Poland
Research Site
NOT_YET_RECRUITING

Poznan, 60-681, Poland
Research Site
NOT_YET_RECRUITING

Poznan, 60-693, Poland
Research Site
NOT_YET_RECRUITING

Poznan, 61-397, Poland
Research Site
RECRUITING

Warsaw, 01-691, Poland
Research Site
NOT_YET_RECRUITING

Warsaw, 02-637, Poland
Research Site
NOT_YET_RECRUITING

Warsaw, 05-077, Poland
Research Site
NOT_YET_RECRUITING

Wroclaw, 53-673, Poland
Research Site
NOT_YET_RECRUITING

Barcelona, 08035, Spain
Research Site
NOT_YET_RECRUITING

Barcelona, 08036, Spain
Research Site
SUSPENDED

Córdoba, 14004, Spain
Research Site
NOT_YET_RECRUITING

Galdakao, 48960, Spain
Research Site
NOT_YET_RECRUITING

Madrid, 28034, Spain
Research Site
NOT_YET_RECRUITING

Madrid, 28046, Spain
Research Site
NOT_YET_RECRUITING

Madrid, 28702, Spain
Research Site
NOT_YET_RECRUITING

Sabadell, 08208, Spain
Research Site
NOT_YET_RECRUITING

Santander, 39008, Spain
Research Site
NOT_YET_RECRUITING

Seville, 41014, Spain
Research Site
NOT_YET_RECRUITING

Valencia, 46026, Spain
Research Site
NOT_YET_RECRUITING

Kaohsiung City, 813414, Taiwan
Research Site
NOT_YET_RECRUITING

Kaohsiung City, 833, Taiwan
Research Site
NOT_YET_RECRUITING

New Taipei City, 23561, Taiwan
Research Site
NOT_YET_RECRUITING

Taichung, 40447, Taiwan
Research Site
NOT_YET_RECRUITING

Taichung, 40705, Taiwan
Research Site
NOT_YET_RECRUITING

Tainan, 70403, Taiwan
Research Site
NOT_YET_RECRUITING

Tainan County, 71044, Taiwan
Research Site
NOT_YET_RECRUITING

Taipei, 100, Taiwan
Research Site
NOT_YET_RECRUITING

Taoyuan, 33305, Taiwan
Research Site
NOT_YET_RECRUITING

Zhubei, 302, Taiwan

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