A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
NCT ID: NCT06455449
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2024-06-20
2028-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis
NCT00533091
Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
NCT07103746
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
NCT05379634
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
NCT06284954
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
NCT04540497
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly
Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Placebo (subcutaneous weekly injection)
Matched placebo control subcutaneous injection once weekly
Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body weight 40 kg - ≤ 100 kg
3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
4. Moderate or severe disease activity per core set measurements.
5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
6. No history of active tuberculosis or severe COVID-19.
7. Male and female participants must follow contraception guidelines.
Exclusion Criteria
2. PM and DM patients at a high risk of malignancy.
3. Participants with rapidly progressive interstitial lung disease.
4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
5. Any history of severe case of herpes zoster infection
6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
10. Recent or concurrent enrollment in another clinical study with an investigational product.
11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Irvine, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Denver, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Boca Raton, Florida, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Margate, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Palm Beach Gardens, Florida, United States
Research Site
Plant City, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Willowbrook, Illinois, United States
Research Site
Fairway, Kansas, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Great Neck, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Middleburg Heights, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Summerville, South Carolina, United States
Research Site
Allen, Texas, United States
Research Site
Colleyville, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
North Richland Hills, Texas, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Buenos Aires, , Argentina
Research Site
CABA, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Quilmes, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Camperdown, , Australia
Research Site
Nedlands, , Australia
Research Site
New Lambton, , Australia
Research Site
Southport, , Australia
Research Site
Woodville South, , Australia
Research Site
Graz, , Austria
Research Site
Vienna, , Austria
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Merksem, , Belgium
Research Site
Joinville, , Brazil
Research Site
Juiz de Fora, , Brazil
Research Site
Pelotas, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Salvador, , Brazil
Research Site
Salvador, , Brazil
Research Site
São José do Rio Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Haskovo, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Calgary, Alberta, Canada
Research Site
Calgary, Alberta, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Concepción, , Chile
Research Site
Las Condes, , Chile
Research Site
Osorno, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Santiago, , Chile
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Beijing, , China
Research Site
Chongqing, , China
Research Site
Dongguan, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hengyang, , China
Research Site
Jining, , China
Research Site
Nanjing, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shijiazhuang, , China
Research Site
Wenzhou, , China
Research Site
Zhengzhou, , China
Research Site
Prague, , Czechia
Research Site
Aarhus N, , Denmark
Research Site
Copenhagen, , Denmark
Research Site
Odense C, , Denmark
Research Site
Angers, , France
Research Site
Brest, , France
Research Site
Le Mans, , France
Research Site
Lille, , France
Research Site
Lyon, , France
Research Site
Paris, , France
Research Site
Paris, , France
Research Site
Reims, , France
Research Site
Rouen, , France
Research Site
Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Bad Nauheim, , Germany
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Herne, , Germany
Research Site
München, , Germany
Research Site
Tübingen, , Germany
Research Site
Debrecen, , Hungary
Research Site
Szeged, , Hungary
Research Site
Ahmedabad, , India
Research Site
Ahmedabad, , India
Research Site
Dehradun, , India
Research Site
Gurugram, , India
Research Site
Hyderabad, , India
Research Site
Kolkata, , India
Research Site
Lucknow, , India
Research Site
Mumbai, , India
Research Site
Mumbai, , India
Research Site
Mumbai, , India
Research Site
Mysuru, , India
Research Site
New Delhi, , India
Research Site
Puducherry, , India
Research Site
Secunderabad, , India
Research Site
Afula, , Israel
Research Site
Haifa, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Ancona, , Italy
Research Site
Bari, , Italy
Research Site
Catania, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Padua, , Italy
Research Site
Palermo, , Italy
Research Site
Pavia, , Italy
Research Site
Pisa, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
Research Site
Rozzano, , Italy
Research Site
Siena, , Italy
Research Site
Asahikawa-Shi, , Japan
Research Site
Bunkyō City, , Japan
Research Site
Chiba, , Japan
Research Site
Fukuoka, , Japan
Research Site
Iruma-Gun, , Japan
Research Site
Kawachinagano-shi, , Japan
Research Site
Kawasaki-shi, , Japan
Research Site
Nagoya, , Japan
Research Site
Nagoya, , Japan
Research Site
Okayama, , Japan
Research Site
Omura-shi, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Tachikawa-shi, , Japan
Research Site
Yotsukaido-shi, , Japan
Research Site
Culiacán, , Mexico
Research Site
D.F, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Mexico City, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
Amsterdam, , Netherlands
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Poznan, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Caguas, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
Daejeon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Sabadell, , Spain
Research Site
Valladolid, , Spain
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Wolverhampton, , United Kingdom
Research Site
Hanoi, , Vietnam
Research Site
Hanoi, , Vietnam
Research Site
Hà Nội, , Vietnam
Research Site
Hà Nội, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Hochiminh City, , Vietnam
Research Site
Hồ Chí Minh, , Vietnam
Research Site
Huế, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Soares RB, Gabr JB, Ash M, Hosler G. Anifrolumab in Refractory Dermatomyositis and Antisynthetase Syndrome. Case Rep Rheumatol. 2025 Apr 21;2025:5560523. doi: 10.1155/crrh/5560523. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D3463C00003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.