Polymyositis, DermatomyositisPhase 3JASMINENCT06455449

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)

A Phase 3 study testing Anifrolumab (blinded) and Anifrolumab (unblinded, open label) in people with Polymyositis, Dermatomyositis, run by AstraZeneca at 237 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Polymyositis, Dermatomyositis
What is being tested?: Anifrolumab (blinded) and Anifrolumab (unblinded, open label)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 237 sitesin 29 countries
Study dates: 20 Jun 2024to 9 Apr 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 - 75 years old
Body weight ≥40 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
No history of active tuberculosis or severe COVID-19.
Male and female participants must follow contraception guidelines.

Who cannot join

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).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
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.
Any history of severe case of herpes zoster infection
History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .

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Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
Recent or concurrent enrollment in another clinical study with an investigational product.
Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

Trial locations and contacts

237 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

237 sites in 29 countries

United States43 sites, 34 recruiting

Research Site
Allen, Texas, 75013
Recruiting
Research Site
Amarillo, Texas, 79124
Recruiting
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Ann Arbor, Michigan, 48109
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Atlanta, Georgia, 30322
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Aurora, Colorado, 80045
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Austin, Texas, 78759
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Baltimore, Maryland, 21224
Recruiting
Research Site
Beckley, West Virginia, 25801
Withdrawn
Research Site
Boca Raton, Florida, 33486
Recruiting
Research Site
Boston, Massachusetts, 02115
Recruiting
Research Site
Boynton Beach, Florida, 33472
Withdrawn
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Charleston, South Carolina, 29425
Recruiting
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Charlotte, North Carolina, 28207
Withdrawn
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Charlotte, North Carolina, 28211
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Cleveland, Ohio, 44195
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Colleyville, Texas, 76034
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Denver, Colorado, 80230
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Durham, North Carolina, 27710
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El Paso, Texas, 79902
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Fairway, Kansas, 66205
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Gainesville, Florida, 32603
Withdrawn
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Galveston, Texas, 77555
Withdrawn
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Great Neck, New York, 11021
Recruiting
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Harlingen, Texas, 78550
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Houston, Texas, 77030
Withdrawn
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Irvine, California, 92617
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Margate, Florida, 33063
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Miami, Florida, 33126
Withdrawn
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Miami, Florida, 33133
Recruiting
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Middleburg Heights, Ohio, 44130
Withdrawn
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Milwaukee, Wisconsin, 53226
Recruiting
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New Haven, Connecticut, 06519
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North Richland Hills, Texas, 76180
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Orlando, Florida, 32819
Recruiting
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Palm Beach Gardens, Florida, 33410
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Philadelphia, Pennsylvania, 19107
Not yet recruiting
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Phoenix, Arizona, 85032
Not yet recruiting
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Pittsburgh, Pennsylvania, 15213
Recruiting
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Plant City, Florida, 33563
Recruiting
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Sterling Heights, Michigan, 48313
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Summerville, South Carolina, 29486
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Washington D.C., District of Columbia, 20037
Withdrawn
Research Site
Willowbrook, Illinois, 60527
Recruiting

Other trials in United States

China19 sites, 18 recruiting

Research Site
Beijing, 100029
Recruiting
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Beijing, 100044
Withdrawn
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Beijing, 100191
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Beijing, CN-100730
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Chongqing, 402260
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Dongguan, 523009
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Guangzhou, 510317
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Guangzhou, 510630
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Hangzhou, 310014
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Hengyang, 421001
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Jining, 272011
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Nanjing, 210029
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Shanghai, 200025
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Shanghai, 200032
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Shanghai, 200040
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Shanghai
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Shijiazhuang, 050001
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Wenzhou, 325000
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Zhengzhou, 450052
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Other trials in China

Japan17 sites, 16 recruiting

Research Site
Asahikawa-Shi, 070-8644
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Bunkyō City, 113-8431
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Bunkyō City, 113-8603
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Chiba, 260-0877
Withdrawn
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Fukuoka, 810-8563
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Hiroshima, 734-8551
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Iruma-Gun, 350-0495
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Kawachinagano-shi, 586-8521
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Kawasaki-shi, 216-8511
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Nagoya, 457-0866
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Nagoya, 467-0001
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Okayama, 700-8557
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Omura-shi, 856-8562
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Sendai, 980-8574
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Shinjuku-ku, 160-8582
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Tachikawa-shi, 190-0014
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Yotsukaido-shi, 284-0003
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Other trials in Japan

India16 sites, 8 recruiting

Research Site
Ahmedabad, 380006
Withdrawn
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Ahmedabad, 382421
Withdrawn
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Bangalore, 560079
Not yet recruiting
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Dehradun, 248016
Withdrawn
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Delhi, 110029
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Gurugram, 122001
Withdrawn
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Hyderabad, 500082
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Kolkata, 700020
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Lucknow, 226030
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Mumbai, 400 078
Withdrawn
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Mumbai, 400012
Withdrawn
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Mumbai, 400053
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Mysuru, 570004
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New Delhi, 110060
Withdrawn
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Puducherry, 605006
Withdrawn
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Secunderabad, 500003
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Other trials in India

Italy14 sites, 8 recruiting

Research Site
Ancona, 60126
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Bari, 70124
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Catania, 95100
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Milan, 20132
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Milan, 20161
Withdrawn
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Padova, 35128
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Palermo, 90127
Withdrawn
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Pavia, 27100
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Pisa, 56126
Withdrawn
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Roma, 00128
Withdrawn
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Roma, 00161
Withdrawn
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Roma, 00189
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Rozzano, 20089
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Siena, 53100
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Other trials in Italy

France11 sites, 11 recruiting

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Angers, 49033
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Brest, 29609
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Le Mans, 72037
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Lille, 59037
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Lyon, 69437
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Paris, 75010
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Paris, 75651
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Reims, 51100
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Rouen, 76000
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Strasbourg, 67098
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Toulouse, 31059
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Other trials in France

Spain10 sites, 7 recruiting

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A Coruña, 15006
Suspended
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Barcelona, 08003
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Barcelona, 08035
Withdrawn
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Barcelona, 08041
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Córdoba, 14004
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L'Hospitalet de Llobregat, 08907
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Madrid, 28034
Withdrawn
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Madrid, 28041
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Sabadell, 08208
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Valladolid, 47012
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Other trials in Spain

Brazil9 sites, 8 recruiting

Research Site
Joinville, 89202-190
Recruiting
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Juiz de Fora, 36010 570
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Pelotas, 96040-010
Withdrawn
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Porto Alegre, 90620-110
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Salvador, 40150-150
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Salvador, 41253-190
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São José do Rio Preto, 15090-000
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São Paulo, 01233-907
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São Paulo, 5403-000
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Other trials in Brazil

Mexico9 sites, 7 recruiting

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Culiacán, 80020
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D.F, 14000
Withdrawn
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Guadalajara, 44600
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Guadalajara, 44650
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Guadalajara, 44690
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México, 06090
Withdrawn
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México, 11850
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Mexico City, 03310
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Mexico City, 06700
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Other trials in Mexico

Poland9 sites, 7 recruiting

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Bialystok, 15-276
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Krakow, 30-002
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Krakow, 30-105
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Lodz, 90-549
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Poznan, 60-218
Suspended
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Poznan, 61-545
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Warsaw, 00-874
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Warsaw, 02-637
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Wroclaw, 50-556
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Other trials in Poland

Vietnam9 sites, 5 recruiting

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Hà Nội, 100000
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Hà Nội, 100000
Withdrawn
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Hanoi, 100000
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Hanoi, 10000
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Hồ Chí Minh, 700000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 700000
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Hochiminh City, 700000
Withdrawn
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Huế, 530000
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Other trials in Vietnam

Bulgaria7 sites, 5 recruiting

Research Site
Haskovo, 6304
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Plovdiv, 4001
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Plovdiv, 4002
Withdrawn
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Plovdiv, 4002
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Rousse, 7000
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Sofia, 1680
Recruiting
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Stara Zagora, 6003
Withdrawn

Other trials in Bulgaria

Germany7 sites, 4 recruiting

Research Site
Bad Nauheim, 61231
Withdrawn
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Berlin, 10117
Active, not recruiting
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Bonn, 53127
Recruiting
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Freiburg im Breisgau, 79106
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Herne, 44649
Withdrawn
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München, 80336
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Tübingen, 72076
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Other trials in Germany

Taiwan7 sites, 3 recruiting

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Kaohsiung City, 81362
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Kaohsiung City, 833
Recruiting
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New Taipei City, 220
Withdrawn
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Taichung, 40447
Terminated
Research Site
Taichung, 40705
Recruiting
Research Site
Taipei, 112
Withdrawn
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Taoyuan, 333
Withdrawn

Other trials in Taiwan

Chile6 sites, 4 recruiting

Research Site
Concepción, 4070022
Recruiting
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Las Condes, 7560908
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Osorno, 200025
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Santiago, 7691236
Withdrawn
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Santiago, 8330034
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Santiago, 8420383
Withdrawn

Other trials in Chile

Israel6 sites, 6 recruiting

Research Site
Afula, 18101
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Haifa, 31048
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Haifa, 34362
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Jerusalem, 91120
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Kfar Saba, 4428164
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Ramat Gan, 52621
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Other trials in Israel

Argentina5 sites, 5 recruiting

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Buenos Aires, C1180AAX
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CABA, C1431FWO
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Ciudad de Buenos Aires, C1405BCH
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Quilmes, B1878GEG
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San Miguel de Tucumán, T4000AXL
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Other trials in Argentina

Australia5 sites, 4 recruiting

Research Site
Camperdown, 2050
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Nedlands, 6009
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New Lambton, 2310
Withdrawn
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Southport, 4222
Recruiting
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Woodville South, 5011
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Other trials in Australia

South Korea5 sites, 5 recruiting

Research Site
Daejeon, 35015
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Seoul, 02447
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Seoul, 04401
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Research Site
Seoul, 06591
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Seoul, 133792
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Other trials in South Korea

Belgium3 sites, 2 recruiting

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Ghent, 9000
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Leuven, 3000
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Research Site
Merksem, B-2170
Withdrawn

Other trials in Belgium

Canada3 sites, 2 recruiting

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Calgary, Alberta, T2N 4L7
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Calgary, Alberta, T3M1M4
Withdrawn
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Montreal, Quebec, H3T 1E2
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Other trials in Canada

Denmark3 sites, 2 recruiting

Research Site
Aarhus N, 8200
Recruiting
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Copenhagen, 2100
Withdrawn
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Odense C, 5000
Recruiting

Other trials in Denmark

Hungary3 sites, 3 recruiting

Research Site
Budapest, 1023
Not yet recruiting
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Debrecen, 4032
Recruiting
Research Site
Szeged, 6725
Recruiting

Other trials in Hungary

United Kingdom3 sites, 3 recruiting

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Edinburgh, EH4 2XU
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London, NW3 2QG
Recruiting
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Wolverhampton, WV10 0QP
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Other trials in United Kingdom

Austria2 sites, 2 recruiting

Research Site
Graz, 8036
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Vienna, 1090
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Puerto Rico2 sites, 2 recruiting

Research Site
Caguas, 00725
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San Juan, 00918
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Sweden2 sites, 1 recruiting

Research Site
Stockholm, 171 76
Withdrawn
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Uppsala, 751 85
Recruiting

Other trials in Sweden

Czechia1 site, 1 recruiting

Research Site
Prague, 12850
Recruiting

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Netherlands1 site, 1 recruiting

Research Site
Amsterdam, 1105 AZ
Recruiting

Other trials in Netherlands

About this study

Official title: A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III 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)

Conditions: Polymyositis, Dermatomyositis
Being tested: Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label)
Keywords: Polymyositis, Dermatomyositis, anifrolumab
Medical subject headings: Dermatomyositis, Polymyositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06455449
Study group	Role	What they receive
Anifrolumab (subcutaneous weekly injection)	Experimental	Anifrolumab subcutaneous injection once weekly Receives: Combination Product: Anifrolumab (blinded); Combination Product: Anifrolumab (unblinded, open label)
Placebo (subcutaneous weekly injection)	Placebo comparator	Matched placebo control subcutaneous injection once weekly Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Improvement Score (TIS) ≥ 40 response
Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits
Measured: 52 week

Secondary outcomes (15)

Manual Muscle Testing 8 (MMT-8) (CSM)
MMT-8 (CSM) change from baseline at Week 52.
Measured: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day
Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Measured: 52 week
Moderate improvement in disease activity in participants with polymyositis (PM)
Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52.
Measured: 52 week
Moderate improvement in disease activity in dermatomyositis (DM) participants.
Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40).
Measured: 52 week
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
CDASI activity change from baseline at Week 8 in DM participants only.
Measured: 8 week
Manual Muscle Testing 8 (MMT-8) in PM participants
MMT-8 change from baseline at Week 52 in PM participants only.
Measured: 52 Week
Manual Muscle Testing 8 (MMT-8) in DM participants
MMT-8 change from baseline at Week 52 in DM participants only.
Measured: 52 Week
Core Set Measures (CSMs)
Change from baseline at Week 52 in CSMs:
- PGA
- PtGA
- Muscle enzymes
- MDAAT extra-muscular disease activity
- HAQ-DI
Measured: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants
PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52
Measured: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants
DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52.
Measured: 52 week
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
DM Participants with CDA-IGA ≥ 2 at baseline who achieve:
- CDA-IGA score ≤ 1 at Week 8 (yes/no)
- CDA-IGA score ≤ 1 at Week 24 (yes/no)
- CDA-IGA score ≤ 1 at Week 52 (yes/no)
Measured: 8, 24, & 52 week
5-D itch
DM participants with CDASI activity > 14 at baseline only:
- 5-D itch change from baseline at Week 8
- 5-D itch change from baseline at Week 24
- 5-D itch change from baseline at Week 52
Measured: 8, 24, & 52 week
Total Improvement Score (TIS) ≥ 20 Response
Participants who have at least minimal improvement in disease activity TIS ≥ 20 at Week 8 and has not met "confirmed deterioration" criteria at 2 consecutive visits up and including Week 8
Measured: 8 week
Total Improvement Score ≥ 60 Response
Participants who have major improvement in disease activity TIS ≥ 60 at week 52 and has not met "confirmed deterioration" criteria at 2 consecutive visits up to and including Week 52
Measured: 52 week
Cumulative Corticosteroid Use
- Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 24
- Cumulative corticosteroids use as determined by the normalized standardized AUC from baseline up to and including Week 52
Measured: 24, 52 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 20249 Apr 2029

First posted12 Jun 2024
Study start20 Jun 2024
Primary completion10 Jan 2028 (estimated)
Study completion9 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polymyositis, DermatomyositisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06455449
Sponsor's protocol ID: D3463C00003
Acronym: JASMINE
Status last verified: Jul 2026
First submitted: 28 Sep 2023
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

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.
PubMed 40297385

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III 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)
ClinicalTrials.gov ID: NCT06455449
Acronym / sponsor ID: JASMINE / D3463C00003
Conditions: Polymyositis, Dermatomyositis
Keywords: Polymyositis, Dermatomyositis, anifrolumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 20 Jun 2024 (actual)
Primary completion: 10 Jan 2028 (estimated)
Study completion: 9 Apr 2029 (estimated)
First posted: 12 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Anifrolumab (subcutaneous weekly injection)	Experimental	Combination Product: Anifrolumab (blinded), Combination Product: Anifrolumab (unblinded, open label)Anifrolumab subcutaneous injection once weekly
Placebo (subcutaneous weekly injection)	Placebo comparator	Other: PlaceboMatched placebo control subcutaneous injection once weekly

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

18 - 75 years old
Body weight ≥40 kg
Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
Moderate or severe disease activity per core set measurements.
Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.

Key exclusion criteria (11 listed)

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).
PM and DM patients at a high risk of malignancy.
Participants with rapidly progressive interstitial lung disease.
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.
Any history of severe case of herpes zoster infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anifrolumab (blinded)Also: Treatment arm (blinded)Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks	Combination product	Anifrolumab (subcutaneous weekly injection)
PlaceboAlso: Placebo arm (blinded)Matched placebo delivered subcutaneously, once weekly for 52 weeks	Other	Placebo (subcutaneous weekly injection)
Anifrolumab (unblinded, open label)Also: treatment arm (unblinded)At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks	Combination product	Anifrolumab (subcutaneous weekly injection)

Primary outcome

Total Improvement Score (TIS) ≥ 40 response
Time frame: 52 week
Participants who have at least moderate improvement in disease activity TIS ≥ 40 and has not met "confirmed deterioration" criteria at 2 consecutive visits

15 secondary outcomes

Manual Muscle Testing 8 (MMT-8) (CSM)
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day
Time frame: 52 week
Moderate improvement in disease activity in participants with polymyositis (PM)
Time frame: 52 week
Moderate improvement in disease activity in dermatomyositis (DM) participants.
Time frame: 52 week
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Time frame: 8 week
Manual Muscle Testing 8 (MMT-8) in PM participants
Time frame: 52 Week
Manual Muscle Testing 8 (MMT-8) in DM participants
Time frame: 52 Week
Core Set Measures (CSMs)
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants
Time frame: 52 week
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants
Time frame: 52 week
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
Time frame: 8, 24, & 52 week
5-D itch
Time frame: 8, 24, & 52 week
Total Improvement Score (TIS) ≥ 20 Response
Time frame: 8 week
Total Improvement Score ≥ 60 Response
Time frame: 52 week
Cumulative Corticosteroid Use
Time frame: 24, 52 week

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Derived from this study: PubMed 40297385Soares 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.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

237 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anifrolumab (blinded) and Anifrolumab (unblinded, open label) in people with Polymyositis, Dermatomyositis, run by AstraZeneca at 237 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 237 sites in United States, China, Japan, India, Italy and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Improvement Score (TIS) ≥ 40 response (time frame: 52 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.