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New shot may tame stubborn lupus skin lesions

NCT ID NCT06015737

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 30, 2026 · Updated 4 times

Summary

This study tests anifrolumab, a biologic drug given as a shot, for adults with chronic or subacute lupus skin rashes that didn't get better with antimalarial drugs. About 306 participants will receive either anifrolumab or a placebo to see if the drug can reduce skin disease activity by 70% or more. The goal is to find a new treatment option for people with this painful and visible condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anifrolumab (a biologic drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option for people with lupus-related skin rashes that don't respond to standard antimalarial drugs.
What could go wrong
This is a Phase 3 trial, but results are not yet available. Anifrolumab may not work better than placebo, and side effects like infections are possible.

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

339 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Aug 2027

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.

Key inclusion criteria: * Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following: * CLASI-A total score ≥ 10 points at Screening and confirmed at randomization. * Inadequate response or intolerant to antimalarial therapy. * Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result. * Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Key exclusion criteria: * History or evidence of suicidal ideation. * Severe or life-threatening Systemic lupus erythematosus (SLE). * Active SLE or Sjögren's Syndrome. * Any active skin conditions other than CLE that may interfere with the study. * History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS). * History of recurrent infection requiring hospitalization and IV antibiotics. * COVID-19 infection. * Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies. * At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

cutaneous lupus erythematosus discoid lupus erythematosus

As listed by the trial registrant

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

Cutaneous lupus erythematosus

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85028, United States

  • Research Site

    Covina, California, 91722, United States

  • Research Site

    La Jolla, California, 92037, United States

  • Research Site

    Los Angeles, California, 90045, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    San Francisco, California, 94143, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    New Haven, Connecticut, 06519, United States

  • Research Site

    Washington D.C., District of Columbia, 20037, United States

  • Research Site

    Fort Lauderdale, Florida, 33309, United States

  • Research Site

    Miami, Florida, 33174, United States

  • Research Site

    Plantation, Florida, 33324, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Indianapolis, Indiana, 46202, United States

  • Research Site

    Baltimore, Maryland, 21287, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02115-5817, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Bloomfield Hills, Michigan, 48302, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Omaha, Nebraska, 68198-5885, United States

  • Research Site

    New York, New York, 10028, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Charlotte, North Carolina, 28207, United States

  • Research Site

    Statesville, North Carolina, 28625, United States

  • Research Site

    Cleveland, Ohio, 44195, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    Providence, Rhode Island, 02903, United States

  • Research Site

    Charleston, South Carolina, 29425, United States

  • Research Site

    Dallas, Texas, 75390-8843, United States

  • Research Site

    Charlottesville, Virginia, 22903, United States

  • Research Site

    Roanoke, Virginia, 24016, United States

  • Research Site

    Ciudad de Buenos Aires, 1221, Argentina

  • Research Site

    Córdoba, 5000, Argentina

  • Research Site

    Córdoba, X5004BAL, Argentina

  • Research Site

    Quilmes, 1878, Argentina

  • Research Site

    San Miguel, 1663, Argentina

  • Research Site

    Kogarah, 3168, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Mitcham, 3132, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Woolloongabba, 04102, Australia

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Innsbruck, 6020, Austria

  • Research Site

    Linz, 4020, Austria

  • Research Site

    Vienna, 1130, Austria

  • Research Site

    Belo Horizonte, 30150-221, Brazil

  • Research Site

    Porto Alegre, 90035903, Brazil

  • Research Site

    Rio de Janeiro, 22470-220, Brazil

  • Research Site

    Salvador, 40150-150, Brazil

  • Research Site

    São Paulo, 05403-000, Brazil

  • Research Site

    Sofia, 1463, Bulgaria

  • Research Site

    Sofia, 1528, Bulgaria

  • Research Site

    Sofia, 1784, Bulgaria

  • Research Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Research Site

    Hamilton, Ontario, L8N 3Z5, Canada

  • Research Site

    Toronto, Ontario, M5T 2S8, Canada

  • Research Site

    Osorno, 200025, Chile

  • Research Site

    Santiago, 130021, Chile

  • Research Site

    Santiago, 7500571, Chile

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changsha, 410011, China

  • Research Site

    Chengdu, 610021, China

  • Research Site

    Chongqing, 400016, China

  • Research Site

    Dongguan, 523059, China

  • Research Site

    Guangzhou, 510120, China

  • Research Site

    Heilongjiang, 150086, China

  • Research Site

    Jinan, 250022, China

  • Research Site

    Shanghai, 200025, China

  • Research Site

    Shanghai, 200443, China

  • Research Site

    Shenzhen, 518020, China

  • Research Site

    Shenzhen, 518052, China

  • Research Site

    Shenzhen, 518053, China

  • Research Site

    Ürümqi, CN-830004, China

  • Research Site

    Zhuzhou, 412007, China

  • Research Site

    Barranquilla, 080020, Colombia

  • Research Site

    Bogotá, 110221, Colombia

  • Research Site

    Aarhus, 641-8510, Denmark

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Bois-Guillaume, 76031, France

  • Research Site

    Dijon, 21000, France

  • Research Site

    Lyon, 69437, France

  • Research Site

    Montivilliers, 76290, France

  • Research Site

    Nantes, 44000, France

  • Research Site

    Paris, 75010, France

  • Research Site

    Paris, 75013, France

  • Research Site

    Paris, 75014, France

  • Research Site

    Paris, 75970, France

  • Research Site

    Poitiers, 86000, FR, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Bochum, 44791, Germany

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Essen, 45147, Germany

  • Research Site

    Freiburg im Breisgau, 79104, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Kiel, 24105, Germany

  • Research Site

    Leipzig, 04103, Germany

  • Research Site

    Mainz, 55131, Germany

  • Research Site

    Marburg, 35043, Germany

  • Research Site

    Regensburg, 93053, Germany

  • Research Site

    Wuppertal, 42283, Germany

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Athens, 16121, Greece

  • Research Site

    Brescia, 25123, Italy

  • Research Site

    Cona, 44124, Italy

  • Research Site

    Florence, 50121, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Naples, 80138, Italy

  • Research Site

    Reggio Emilia, 42123, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Rome, 00168, Italy

  • Research Site

    Chūōku, 104-8560, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kita-gun, 761-0793, Japan

  • Research Site

    Nagoya, 457-8510, Japan

  • Research Site

    Nagoya, 467-8602, Japan

  • Research Site

    tabashi City, 173-8606, Japan

  • Research Site

    Wakayama, 641-8510, Japan

  • Research Site

    Yokohama, 232-0024, Japan

  • Research Site

    Guadalajara, 44340, Mexico

  • Research Site

    Guadalajara, 44610, Mexico

  • Research Site

    Mexico City, 07760, Mexico

  • Research Site

    Veracruz, 91910, Mexico

  • Research Site

    Breda, 4818 CK, Netherlands

  • Research Site

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    Papatoetoe, 2025, New Zealand

  • Research Site

    Iloilo City, 5000, Philippines

  • Research Site

    Lipa, 4217, Philippines

  • Research Site

    Manila, 1000, Philippines

  • Research Site

    Katowice, 40-851, Poland

  • Research Site

    Kielce, 25-316, Poland

  • Research Site

    Ossy, 40-027, Poland

  • Research Site

    Rzeszów, 35-055, Poland

  • Research Site

    Warsaw, 02-637, Poland

  • Research Site

    Braga, 4710-243, Portugal

  • Research Site

    Lisbon, 1649-035, Portugal

  • Research Site

    Porto, 4099-001, Portugal

  • Research Site

    Bucharest, 020125, Romania

  • Research Site

    Iași, 700291, Romania

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Kragujevac, 34000, Serbia

  • Research Site

    Košice, 04001, Slovakia

  • Research Site

    Piešťany, 92101, Slovakia

  • Research Site

    Cape Town, 7500, South Africa

  • Research Site

    Johannesburg, 2193, South Africa

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 06973, South Korea

  • Research Site

    Barcelona, 08025, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Castellon, 12004, Spain

  • Research Site

    Granada, 18012, Spain

  • Research Site

    L'Hospitalet de Llobregat, 08907, Spain

  • Research Site

    Las Palmas de Gran Canaria, 35010, Spain

  • Research Site

    Madrid, 28006, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    Seville, 41014, Spain

  • Research Site

    Valencia, 46014, Spain

  • Research Site

    Valencia, 46017, Spain

  • Research Site

    Vigo, 36200, Spain

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khlong Luang, 12120, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    Samsun, 55270, Turkey (Türkiye)

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Leeds, LS2 9JT, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    London, NW3 2QG, United Kingdom

  • Research Site

    London, SE1 7EH, United Kingdom

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE1 4LP, United Kingdom

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