A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Launched by ASTRAZENECA · Aug 22, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called anifrolumab to see if it helps adults with a skin condition known as cutaneous lupus erythematosus (CLE). The trial will compare the effects of anifrolumab, given as a shot under the skin, with a placebo (a harmless substance that looks like the medication but has no active ingredients) to find out which is more effective. Researchers want to determine if anifrolumab is safe and if it can improve the symptoms of CLE in those who have not responded well to standard treatments.
To participate in this study, individuals must be adults aged 18 to 75 with a confirmed diagnosis of CLE, showing certain severity levels in their skin symptoms. They should have tried other treatments without success. Participants will be screened for conditions like tuberculosis and must be free from severe other illnesses. Those who join can expect regular check-ups and monitoring throughout the trial to ensure their safety. It's also important to note that they must test negative for COVID-19 at the start of the study. If you think you might be eligible, it's a good idea to discuss this trial with your healthcare provider for more information.
Gender
ALL
Eligibility criteria
- 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.
- • CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 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.
- • Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
- 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 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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Rochester, Minnesota, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Indianapolis, Indiana, United States
Fountain Valley, California, United States
Liège, , Belgium
Salamanca, , Spain
Aurora, Colorado, United States
Baltimore, Maryland, United States
Charlotte, North Carolina, United States
Dresden, , Germany
New York, New York, United States
Berlin, , Germany
Kiel, , Germany
Milano, , Italy
San Francisco, California, United States
Portland, Oregon, United States
Seattle, Washington, United States
Leuven, , Belgium
Bordeaux, , France
Paris, , France
Roma, , Italy
Nijmegen, , Netherlands
Cape Town, , South Africa
Sofia, , Bulgaria
Barcelona, , Spain
Miami, Florida, United States
Philadelphia, Pennsylvania, United States
Erlangen, , Germany
Graz, , Austria
Innsbruck, , Austria
Wien, , Austria
Hannover, , Germany
Regensburg, , Germany
Breda, , Netherlands
Rotterdam, , Netherlands
Charlottesville, Virginia, United States
Orange, California, United States
La Jolla, California, United States
Galveston, Texas, United States
Lille Cedex, , France
Mainz, , Germany
Ann Arbor, Michigan, United States
Glendale, Arizona, United States
Denver, Colorado, United States
Lisboa, , Portugal
Brooklyn, New York, United States
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Charleston, South Carolina, United States
Bochum, , Germany
Marburg, , Germany
Athens, , Greece
Newcastle Upon Tyne, , United Kingdom
Cambridge, , United Kingdom
London, , United Kingdom
Linz, , Austria
Brescia, , Italy
Los Angeles, California, United States
Plantation, Florida, United States
Providence, Rhode Island, United States
Manila, , Philippines
Johannesburg, , South Africa
Essen, , Germany
Barcelona, , Spain
Box Hill, , Australia
Leipzig, , Germany
Hamilton, , New Zealand
Warszawa, , Poland
Belgrade, , Serbia
Kragujevac, , Serbia
Vancouver, British Columbia, Canada
Mesquite, Texas, United States
Beijing, , China
Shanghai, , China
Bruxelles, , Belgium
Montivilliers, , France
Porto, , Portugal
Sao Paulo, , Brazil
Majadahonda, , Spain
Cona, , Italy
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Chuo Ku, , Japan
Iloilo City, , Philippines
Bangkok, , Thailand
Amsterdam, , Netherlands
Nice, , France
Toulouse Cedex 9, , France
Dijon, , France
Bloomfield Hills, Michigan, United States
Statesville, North Carolina, United States
Clayton, , Australia
Chongqing, , China
Guangzhou, , China
Shijiazhuang, , China
Granada, , Spain
Ann Arbor, Michigan, United States
København, , Denmark
Taipei, , Taiwan
Braga, , Portugal
Madrid, , Spain
Kaohsiung, , Taiwan
New Haven, Connecticut, United States
Newmarket, Ontario, Canada
Edmonton, Alberta, Canada
L'hospitalet De Llobregat, , Spain
Sevilla, , Spain
Valencia, , Spain
Roanoke, Virginia, United States
Changchun, , China
Hangzhou, , China
Veracruz, , Mexico
Seoul, , Korea, Republic Of
Fort Lauderdale, Florida, United States
Lyon Cedex 03, , France
Melbourne, , Australia
Changsha, , China
Nanchang, , China
Seoul, , Korea, Republic Of
Košice, , Slovakia
Porto Alegre, , Brazil
Chambray Les Tours, , France
Bucharest, , Romania
Svidnik, , Slovakia
Okayama Shi, , Japan
Shenzhen, , China
Malvern, , Australia
Santiago, , Chile
Osaka Shi, , Japan
Sofia, , Bulgaria
Guadalajara, , Mexico
Rzeszów, , Poland
Hat Yai, , Thailand
Kayseri, , Turkey
Nagoya Shi, , Japan
Hamburg, , Germany
Istanbul, , Turkey
Westmead, , Australia
Napoli, , Italy
Bunkyo Ku, , Japan
Yokohama Shi, , Japan
Bois Guillaume, , France
Taichung, , Taiwan
Nagasaki Shi, , Japan
Fukuoka Shi, , Japan
Kanazawa Shi, , Japan
Woolloongabba, , Australia
Sapporo, , Japan
Reggio Emilia, , Italy
Quilmes, , Argentina
Omura Shi, , Japan
Stellenbosch, , South Africa
Las Palmas De Gran Canaria, , Spain
Vigo, , Spain
Belo Horizonte, , Brazil
Salvador, , Brazil
Bogota, , Colombia
Baotou, , China
Papatoetoe, , New Zealand
Kita Gun, , Japan
Córdoba, , Argentina
Rosario, , Argentina
La Coruña, , Spain
Rome, , Italy
Summerville, South Carolina, United States
Poznan, , Poland
Covina, California, United States
Athens, , Greece
Belo Horizonte, , Brazil
Karsiyaka, , Turkey
Ciudad De Buenos Aires, , Argentina
Wuhan, , China
Khlong Luang, , Thailand
Zhuzhou, , China
València, , Spain
Kunming, , China
Castellon De La Plana, , Spain
New York, New York, United States
Cleveland, Ohio, United States
Nantes, , France
Urumqi, , China
Nanjing, , China
Florence, , Italy
Wuppertal, , Germany
Coimbra, , Portugal
Chia, , Colombia
Wakayama, , Japan
Jinan, , China
Ono, , Japan
Chengdu, , China
Khon Kaen, , Thailand
Omaha, Nebraska, United States
Freiburg, , Germany
Marche, , Italy
San Luis Potosi, , Mexico
Zapopan, , Mexico
Dallas, Texas, United States
Chapel Hill, North Carolina, United States
Nagoya, , Japan
Phoenix, Arizona, United States
Samsun, , Turkey
Sankt Pölten, , Austria
Lyon, , France
Torrette, , Italy
Boston, Massachusetts, United States
Shanghai, , China
Barranquilla, , Colombia
Lipa, , Philippines
Olsztyn, , Poland
Suita, , Japan
Heilongjiang, , China
Katowice, , Poland
Warszawa, , Poland
Leeds, , United Kingdom
Yotsukaido Shi, , Japan
San Miguel, , Argentina
Osorno, , Chile
Cuernavaca, , Mexico
Ossy, , Poland
Rio De Janeiro, , Brazil
Aarhus, , Denmark
Yokohama, , Japan
Gdynia, , Poland
Piestany, , Slovakia
Kogarah, , Australia
Itabashi, , Japan
Kielce, , Poland
Craiova, , Romania
Targu Mures, , Romania
Santiago, , Chile
Ciudad De Mexico, , Mexico
Bucuresti, , Romania
Iasi, , Romania
Murray, Kentucky, United States
Poitiers, , France
Midland Park, New Jersey, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported