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)

Description

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.

Interventions

Anifrolumab (blinded) (Combination product)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Placebo (Other)
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Anifrolumab (unblinded, open label) (Combination product)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks

Eligibility criteria

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

Conditions

Polymyositis, Dermatomyositis

Locations

Research Site — Phoenix, Arizona, United States
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 — 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 — Sterling Heights, 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 — Philadelphia, Pennsylvania, 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 — Amarillo, Texas, United States
Research Site — Austin, Texas, United States
Research Site — Colleyville, Texas, United States
Research Site — El Paso, Texas, United States
Research Site — Galveston, Texas, United States
Research Site — Harlingen, Texas, United States
Research Site — Houston, Texas, United States
Research Site — North Richland Hills, Texas, United States
Research Site — Beckley, West Virginia, 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 — Rousse, 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 — Budapest, Hungary
Research Site — Debrecen, Hungary
Research Site — Szeged, Hungary
Research Site — Ahmedabad, India
Research Site — Ahmedabad, India
Research Site — Bangalore, India
Research Site — Dehradun, India
Research Site — Delhi, 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 — Padova, 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 — Bunkyō City, Japan
Research Site — Chiba, Japan
Research Site — Fukuoka, Japan
Research Site — Hiroshima, 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, 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 — Ho Chi Minh City, Vietnam
Research Site — Hochiminh City, Vietnam
Research Site — Hồ Chí Minh, Vietnam
Research Site — Huế, Vietnam

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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)

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