Language: BG BG
← Back to results
Recruiting Phase 3 NCT06455449

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)

Phase 3 – large-scale trial before approval
Conditions: Polymyositis, Dermatomyositis

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) \[polymyositis (PM) or dermatomyositis (DM)\] while receiving standard of care (SoC) treatment.
Who can participate
Capable of giving informed consent. Inclusion Criteria: 1. 18 - 75 years old 2. Body weight ≥40 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: 1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies). 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
Interventions
Anifrolumab (blinded)
COMBINATION_PRODUCT
Placebo
OTHER
Anifrolumab (unblinded, open label)
COMBINATION_PRODUCT
Locations 234
Argentina (5)
Research Site
Buenos Aires
Research Site
CABA
Research Site
Ciudad de Buenos Aires
Research Site
Quilmes
Research Site
San Miguel de Tucumán
Australia (5)
Research Site
Camperdown
Research Site
Nedlands
Research Site
New Lambton
WITHDRAWN
Research Site
Southport
Research Site
Woodville South
Austria (2)
Research Site
Graz
Research Site
Vienna
Belgium (3)
Research Site
Ghent
Research Site
Leuven
Research Site
Merksem
WITHDRAWN
Brazil (9)
Research Site
Joinville
Research Site
Juiz de Fora
Research Site
Pelotas
WITHDRAWN
Research Site
Porto Alegre
Research Site
Salvador
Research Site
Salvador
Research Site
São José do Rio Preto
Research Site
São Paulo
Research Site
São Paulo
NOT_YET_RECRUITING
Bulgaria (7)
Research Site
Haskovo
Research Site
Plovdiv
Research Site
Plovdiv
WITHDRAWN
Research Site
Plovdiv
Research Site
Rousse
NOT_YET_RECRUITING
Research Site
Sofia
Research Site
Stara Zagora
WITHDRAWN
Canada (3)
Research Site
Calgary , Alberta
Research Site
Calgary , Alberta
WITHDRAWN
Research Site
Montreal , Quebec
Chile (6)
Research Site
Concepción
Research Site
Las Condes
Research Site
Osorno
Research Site
Santiago
WITHDRAWN
Research Site
Santiago
Research Site
Santiago
WITHDRAWN
China (19)
Research Site
Beijing
Research Site
Beijing
WITHDRAWN
Research Site
Beijing
Research Site
Beijing
Research Site
Chongqing
Research Site
Dongguan
Research Site
Guangzhou
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Hengyang
Research Site
Jining
Research Site
Nanjing
Research Site
Shanghai
Research Site
Shanghai
Research Site
Shanghai
Research Site
Shanghai
Research Site
Shijiazhuang
Research Site
Wenzhou
Research Site
Zhengzhou
Czech Republic (1)
Research Site
Prague
Denmark (3)
Research Site
Aarhus N
Research Site
Copenhagen
WITHDRAWN
Research Site
Odense C
France (11)
Research Site
Angers
Research Site
Brest
Research Site
Le Mans
Research Site
Lille
Research Site
Lyon
Research Site
Paris
Research Site
Paris
Research Site
Reims
Research Site
Rouen
Research Site
Strasbourg
Research Site
Toulouse
Germany (7)
Research Site
Bad Nauheim
WITHDRAWN
Research Site
Berlin
Research Site
Bonn
Research Site
Freiburg im Breisgau
Research Site
Herne
NOT_YET_RECRUITING
Research Site
München
Research Site
Tübingen
Hungary (3)
Research Site
Budapest
NOT_YET_RECRUITING
Research Site
Debrecen
Research Site
Szeged
India (15)
Research Site
Ahmedabad
WITHDRAWN
Research Site
Ahmedabad
WITHDRAWN
Research Site
Dehradun
WITHDRAWN
Research Site
Delhi
NOT_YET_RECRUITING
Research Site
Gurugram
WITHDRAWN
Research Site
Hyderabad
Research Site
Kolkata
Research Site
Lucknow
Research Site
Mumbai
WITHDRAWN
Research Site
Mumbai
WITHDRAWN
Research Site
Mumbai
Research Site
Mysuru
Research Site
New Delhi
WITHDRAWN
Research Site
Puducherry
WITHDRAWN
Research Site
Secunderabad
Israel (6)
Research Site
Afula
Research Site
Haifa
Research Site
Haifa
Research Site
Jerusalem
Research Site
Kfar Saba
Research Site
Ramat Gan
Italy (14)
Research Site
Ancona
Research Site
Bari
Research Site
Catania
Research Site
Milan
Research Site
Milan
WITHDRAWN
Research Site
Padova
Research Site
Palermo
WITHDRAWN
Research Site
Pavia
Research Site
Pisa
WITHDRAWN
Research Site
Roma
WITHDRAWN
Research Site
Roma
WITHDRAWN
Research Site
Roma
Research Site
Rozzano
Research Site
Siena
SUSPENDED
Japan (17)
Research Site
Asahikawa-Shi
Research Site
Bunkyō City
NOT_YET_RECRUITING
Research Site
Bunkyō City
Research Site
Chiba
WITHDRAWN
Research Site
Fukuoka
Research Site
Hiroshima
NOT_YET_RECRUITING
Research Site
Iruma-Gun
Research Site
Kawachinagano-shi
Research Site
Kawasaki-shi
Research Site
Nagoya
Research Site
Nagoya
Research Site
Okayama
Research Site
Omura-shi
Research Site
Sendai
Research Site
Shinjuku-ku
Research Site
Tachikawa-shi
Research Site
Yotsukaido-shi
Mexico (9)
Research Site
Culiacán
Research Site
D.F
WITHDRAWN
Research Site
Guadalajara
Research Site
Guadalajara
NOT_YET_RECRUITING
Research Site
Guadalajara
Research Site
México
WITHDRAWN
Research Site
México
Research Site
Mexico City
Research Site
Mexico City
Netherlands (1)
Research Site
Amsterdam
Poland (9)
Research Site
Bialystok
WITHDRAWN
Research Site
Krakow
Research Site
Krakow
Research Site
Lodz
Research Site
Poznan
Research Site
Poznan
Research Site
Warsaw
Research Site
Warsaw
Research Site
Wroclaw
Puerto Rico (2)
Research Site
Caguas
Research Site
San Juan
South Korea (5)
Research Site
Daejeon
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Research Site
Seoul
Spain (10)
Research Site
A Coruña
ACTIVE_NOT_RECRUITING
Research Site
Barcelona
Research Site
Barcelona
Research Site
Barcelona
Research Site
Córdoba
Research Site
L'Hospitalet de Llobregat
Research Site
Madrid
Research Site
Madrid
Research Site
Sabadell
Research Site
Valladolid
Sweden (2)
Research Site
Stockholm
WITHDRAWN
Research Site
Uppsala
Taiwan (7)
Research Site
Kaohsiung City
Research Site
Kaohsiung City
Research Site
New Taipei City
Research Site
Taichung
TERMINATED
Research Site
Taichung
Research Site
Taipei
WITHDRAWN
Research Site
Taoyuan District
WITHDRAWN
United Kingdom (3)
Research Site
Edinburgh
Research Site
London
Research Site
Wolverhampton
United States (42)
Research Site
Allen , Texas
Research Site
Ann Arbor , Michigan
Research Site
Atlanta , Georgia
Research Site
Aurora , Colorado
Research Site
Austin , Texas
NOT_YET_RECRUITING
Research Site
Baltimore , Maryland
Research Site
Beckley , West Virginia
NOT_YET_RECRUITING
Research Site
Boca Raton , Florida
Research Site
Boston , Massachusetts
NOT_YET_RECRUITING
Research Site
Boynton Beach , Florida
WITHDRAWN
Research Site
Charleston , South Carolina
Research Site
Charlotte , North Carolina
WITHDRAWN
Research Site
Charlotte , North Carolina
Research Site
Cleveland , Ohio
Research Site
Colleyville , Texas
Research Site
Denver , Colorado
NOT_YET_RECRUITING
Research Site
Durham , North Carolina
Research Site
El Paso , Texas
Research Site
Fairway , Kansas
Research Site
Gainesville , Florida
WITHDRAWN
Research Site
Galveston , Texas
WITHDRAWN
Research Site
Great Neck , New York
NOT_YET_RECRUITING
Research Site
Harlingen , Texas
NOT_YET_RECRUITING
Research Site
Houston , Texas
WITHDRAWN
Research Site
Irvine , California
Research Site
Margate , Florida
Research Site
Miami , Florida
WITHDRAWN
Research Site
Miami , Florida
Research Site
Middleburg Heights , Ohio
WITHDRAWN
Research Site
Milwaukee , Wisconsin
Research Site
New Haven , Connecticut
Research Site
North Richland Hills , Texas
Research Site
Orlando , Florida
Research Site
Palm Beach Gardens , Florida
Research Site
Philadelphia , Pennsylvania
NOT_YET_RECRUITING
Research Site
Phoenix , Arizona
NOT_YET_RECRUITING
Research Site
Pittsburgh , Pennsylvania
Research Site
Plant City , Florida
Research Site
Sterling Heights , Michigan
NOT_YET_RECRUITING
Research Site
Summerville , South Carolina
Research Site
Washington D.C. , District of Columbia
WITHDRAWN
Research Site
Willowbrook , Illinois
Vietnam (8)
Research Site
Hà Nội
Research Site
Hà Nội
WITHDRAWN
Research Site
Hanoi
Research Site
Hanoi
WITHDRAWN
Research Site
Hồ Chí Minh
Research Site
Ho Chi Minh City
Research Site
Hochiminh City
WITHDRAWN
Research Site
Huế
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
20.06.2024
Completion date
04.08.2028
Registry ID
NCT06455449
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.