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New lupus shot shows promise in major trial

NCT ID NCT04877691

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests a new medicine called anifrolumab, given as a shot under the skin, for adults with moderate-to-severe lupus. The goal is to see if it can better control disease activity compared to a placebo, when added to standard treatments. About 367 participants are involved in this Phase 3 trial, which is already fully enrolled and active but not recruiting new patients.

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

367 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Nov 2026

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. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF 2. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening 3. BILAG2004 with at least 1 of the following: 1. BILAG2004 level A disease in ≥ 1 organ system 2. BILAG2004 level B disease in ≥ 2 organ systems 4. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening 5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening, 6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations. Exclusion Criteria: 7. Active severe or unstable neuropsychiatric SLE 8. Active severe SLE-driven renal disease 9. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF. 10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 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 patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening. 12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody 13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1), 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization. 15. History of cancer, apart from: 1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1) 2. Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

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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

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35233, United States

  • Research Site

    Paradise Valley, Arizona, 85253, United States

  • Research Site

    Phoenix, Arizona, 85032, United States

  • Research Site

    El Cajon, California, 92020, United States

  • Research Site

    Fullerton, California, 92835, United States

  • Research Site

    Hemet, California, 92543, United States

  • Research Site

    La Mesa, California, 91942, United States

  • Research Site

    Los Angeles, California, 90095, United States

  • Research Site

    Menifee, California, 92586, United States

  • Research Site

    Upland, California, 91786, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Brandon, Florida, 33511, United States

  • Research Site

    Clearwater, Florida, 33759, United States

  • Research Site

    Clearwater, Florida, 33765, United States

  • Research Site

    Miami, Florida, 33180, United States

  • Research Site

    Tampa, Florida, 33613, United States

  • Research Site

    Tampa, Florida, 33614, United States

  • Research Site

    Idaho Falls, Idaho, 83404, United States

  • Research Site

    Flint, Michigan, 48504, United States

  • Research Site

    Lansing, Michigan, 48911, United States

  • Research Site

    Newark, New Jersey, 07103, United States

  • Research Site

    Las Cruces, New Mexico, 88011, United States

  • Research Site

    Brooklyn, New York, 11201, United States

  • Research Site

    Manhasset, New York, 11030, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Potsdam, New York, 13676, United States

  • Research Site

    Charlotte, North Carolina, 28203, United States

  • Research Site

    Charlotte, North Carolina, 28204, United States

  • Research Site

    Oklahoma City, Oklahoma, 73104, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15224, United States

  • Research Site

    Reading, Pennsylvania, 19610, United States

  • Research Site

    Memphis, Tennessee, 38119, United States

  • Research Site

    Grapevine, Texas, 76051, United States

  • Research Site

    Ciudad de Buenos Aires, C1431FWO, Argentina

  • Research Site

    La Plata, 1900, Argentina

  • Research Site

    Mendoza, 5500, Argentina

  • Research Site

    Pergamino, B2700CPM, Argentina

  • Research Site

    Quilmes, B1878GEG, Argentina

  • Research Site

    Rosario, S2000PBJ, Argentina

  • Research Site

    Salta, A4400ANW, Argentina

  • Research Site

    San Isidro, 1643, Argentina

  • Research Site

    San Juan, 5400, Argentina

  • Research Site

    San Miguel de Tucumán, 4000, Argentina

  • Research Site

    San Miguel de Tucumán, T4000AXL, Argentina

  • Research Site

    San Miguel de Tucumán, T4000ICL, Argentina

  • Research Site

    Kardzhali, 6600, Bulgaria

  • Research Site

    Pleven, 5800, Bulgaria

  • Research Site

    Plovdiv, 4003, Bulgaria

  • Research Site

    Sevlievo, 5400, Bulgaria

  • Research Site

    Sofia, 1407, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Sofia, 1606, Bulgaria

  • Research Site

    Sofia, 1784, Bulgaria

  • Research Site

    Sofia, 1797, Bulgaria

  • Research Site

    Osorno, 5290000, Chile

  • Research Site

    Santiago, 7500010, Chile

  • Research Site

    Santiago, 7500571, Chile

  • Research Site

    Santiago, 7500588, Chile

  • Research Site

    Santiago, 7500710, Chile

  • Research Site

    Santiago, 7501126, Chile

  • Research Site

    Santiago, 8320000, Chile

  • Research Site

    Valdivia, 5090000, Chile

  • Research Site

    Barranquilla, 080002, Colombia

  • Research Site

    Barranquilla, 080020, Colombia

  • Research Site

    Bogotá, 110221, Colombia

  • Research Site

    Bucaramanga, 680003, Colombia

  • Research Site

    Chía, 250001, Colombia

  • Research Site

    Montería, 230002, Colombia

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    Tübingen, 72076, Germany

  • Research Site

    Budapest, 1027, Hungary

  • Research Site

    Budapest, 1097, Hungary

  • Research Site

    Gyula, 5700, Hungary

  • Research Site

    Székesfehérvár, 8000, Hungary

  • Research Site

    Veszprém, 8200, Hungary

  • Research Site

    Chiba, 260-8712, Japan

  • Research Site

    Chūōku, 104-8560, Japan

  • Research Site

    Hamamatsu, 431-3192, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Itabashi-ku, 173-8610, Japan

  • Research Site

    Kita-gun, 761-0793, Japan

  • Research Site

    Kitakyushu-shi, 807-8555, Japan

  • Research Site

    Meguro-ku, 152-8902, Japan

  • Research Site

    Meguro-ku, 153-8515, Japan

  • Research Site

    Nagasaki, 852-8501, Japan

  • Research Site

    Nagoya, 457-8510, Japan

  • Research Site

    Nagoya, 460-0001, Japan

  • Research Site

    Okayama, 700-8607, Japan

  • Research Site

    Sagamihara-shi, 252-0375, Japan

  • Research Site

    Sasebo-shi, 857-1195, Japan

  • Research Site

    Sendai, 980-8574, Japan

  • Research Site

    Shinjuku-ku, 160-8582, Japan

  • Research Site

    Chihuahua City, 31000, Mexico

  • Research Site

    Culiacán, 80000, Mexico

  • Research Site

    Durango, 43080, Mexico

  • Research Site

    Guadalajara, 44130, Mexico

  • Research Site

    Guadalajara, 44650, Mexico

  • Research Site

    Guadalajara, 44950, Mexico

  • Research Site

    Mexicali, 21200, Mexico

  • Research Site

    Mérida, 97000, Mexico

  • Research Site

    Mérida, 97070, Mexico

  • Research Site

    México, 03100, Mexico

  • Research Site

    México, 03720, Mexico

  • Research Site

    México, 06700, Mexico

  • Research Site

    Quezon City, 1118, Philippines

  • Research Site

    Katowice, 40-081, Poland

  • Research Site

    Kościan, 64-000, Poland

  • Research Site

    Krakow, 30-033, Poland

  • Research Site

    Krakow, 30-363, Poland

  • Research Site

    Krakow, 30-510, Poland

  • Research Site

    Lodz, 90-368, Poland

  • Research Site

    Lublin, 20-607, Poland

  • Research Site

    Nowa Sól, 67-100, Poland

  • Research Site

    Ustroń, 43-450, Poland

  • Research Site

    Warsaw, 00-874, Poland

  • Research Site

    Warsaw, 02-118, Poland

  • Research Site

    Warsaw, 02-691, Poland

  • Research Site

    Wroclaw, 50-088, Poland

  • Research Site

    Wroclaw, 50-244, Poland

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, 8003, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28702, Spain

  • Research Site

    Santiago de Compostela, 15706, Spain

  • Research Site

    Seville, 41010, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Muang, 50200, Thailand

  • Research Site

    Rachathewi, 10400, Thailand

  • Research Site

    Kyiv, 01601, Ukraine

  • Research Site

    Kyiv, 02091, Ukraine

  • Research Site

    Kyiv, 04050, Ukraine

  • Research Site

    Odesa, 65025, Ukraine

  • Research Site

    Vinnytsia, 21001, Ukraine

  • Research Site

    Vinnytsia, 21029, Ukraine

  • Research Site

    Zaporizhzhya, 69600, Ukraine

  • Research Site

    Doncaster, DN2 5LT, United Kingdom

  • Research Site

    Leeds, LS7 4SA, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

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