En studie for å undersøke effektiviteten og sikkerheten til anifrolumab administrert som subkutan injeksjon og lagt til standardbehandling sammenlignet med placebo lagt til standardbehandling hos voksne deltakere med idiopatiske inflammatoriske myopatier (polymyositt og dermatomyositt) (JASMINE)
23. september 2026 oppdatert av: AstraZeneca
En multisenter, parallellgruppe, dobbeltblind, 2-arm, fase III-studie for å undersøke effektiviteten og sikkerheten til anifrolumab administrert som subkutan injeksjon og lagt til standardbehandling sammenlignet med placebo lagt til standardbehandling hos voksne deltakere med idiopatisk inflammatorisk Myopatier (polymyositt og dermatomyositt)
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studiesteder
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Buenos Aires, Argentina, C1180AAX
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CABA, Argentina, C1431FWO
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Ciudad de Buenos Aires, Argentina, C1405BCH
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Quilmes, Argentina, B1878GEG
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San Miguel de Tucumán, Argentina, T4000AXL
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Camperdown, Australia, 2050
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Nedlands, Australia, 6009
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New Lambton, Australia, 2310
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Southport, Australia, 4222
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Woodville South, Australia, 5011
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Ghent, Belgia, 9000
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Leuven, Belgia, 3000
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Merksem, Belgia, B-2170
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Joinville, Brasil, 89202-190
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Juiz de Fora, Brasil, 36010 570
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Pelotas, Brasil, 96040-010
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Porto Alegre, Brasil, 90620-110
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Salvador, Brasil, 41253-190
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Salvador, Brasil, 40150-150
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São José do Rio Preto, Brasil, 15090-000
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São Paulo, Brasil, 01233-907
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São Paulo, Brasil, 5403-000
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Haskovo, Bulgaria, 6304
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Plovdiv, Bulgaria, 4002
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Plovdiv, Bulgaria, 4002
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Plovdiv, Bulgaria, 4001
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Rousse, Bulgaria, 7000
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Sofia, Bulgaria, 1680
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Stara Zagora, Bulgaria, 6003
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Alberta
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Calgary, Alberta, Canada, T3M1M4
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Calgary, Alberta, Canada, T2N 4L7
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Concepción, Chile, 4070022
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Las Condes, Chile, 7560908
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Osorno, Chile, 200025
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Santiago, Chile, 8420383
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Santiago, Chile, 8330034
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Santiago, Chile, 7691236
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Aarhus N, Danmark, 8200
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Copenhagen, Danmark, 2100
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Odense C, Danmark, 5000
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Arizona
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Phoenix, Arizona, Forente stater, 85032
- Har ikke rekruttert ennå
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California
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Irvine, California, Forente stater, 92617
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Colorado
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Aurora, Colorado, Forente stater, 80045
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Denver, Colorado, Forente stater, 80230
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Connecticut
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New Haven, Connecticut, Forente stater, 06519
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20037
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Florida
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Boca Raton, Florida, Forente stater, 33486
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Boynton Beach, Florida, Forente stater, 33472
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Gainesville, Florida, Forente stater, 32603
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Margate, Florida, Forente stater, 33063
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Miami, Florida, Forente stater, 33126
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Miami, Florida, Forente stater, 33133
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Orlando, Florida, Forente stater, 32819
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Palm Beach Gardens, Florida, Forente stater, 33410
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Plant City, Florida, Forente stater, 33563
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Georgia
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Atlanta, Georgia, Forente stater, 30322
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Illinois
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Willowbrook, Illinois, Forente stater, 60527
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Kansas
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Fairway, Kansas, Forente stater, 66205
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Maryland
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Baltimore, Maryland, Forente stater, 21224
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
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Sterling Heights, Michigan, Forente stater, 48313
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New York
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Great Neck, New York, Forente stater, 11021
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North Carolina
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Charlotte, North Carolina, Forente stater, 28207
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Charlotte, North Carolina, Forente stater, 28211
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Durham, North Carolina, Forente stater, 27710
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Ohio
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Cleveland, Ohio, Forente stater, 44195
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Middleburg Heights, Ohio, Forente stater, 44130
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
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Pittsburgh, Pennsylvania, Forente stater, 15213
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
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Summerville, South Carolina, Forente stater, 29486
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Texas
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Allen, Texas, Forente stater, 75013
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Amarillo, Texas, Forente stater, 79124
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Austin, Texas, Forente stater, 78759
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Colleyville, Texas, Forente stater, 76034
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El Paso, Texas, Forente stater, 79902
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Galveston, Texas, Forente stater, 77555
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Harlingen, Texas, Forente stater, 78550
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Houston, Texas, Forente stater, 77030
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North Richland Hills, Texas, Forente stater, 76180
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West Virginia
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Beckley, West Virginia, Forente stater, 25801
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
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Angers, Frankrike, 49033
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Brest, Frankrike, 29609
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Le Mans, Frankrike, 72037
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Lille, Frankrike, 59037
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Lyon, Frankrike, 69437
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Paris, Frankrike, 75010
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Paris, Frankrike, 75651
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Reims, Frankrike, 51100
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Rouen, Frankrike, 76000
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Strasbourg, Frankrike, 67098
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Toulouse, Frankrike, 31059
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Ahmedabad, India, 380006
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Ahmedabad, India, 382421
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Bangalore, India, 560079
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Dehradun, India, 248016
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Delhi, India, 110029
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Gurugram, India, 122001
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Hyderabad, India, 500082
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Kolkata, India, 700020
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Lucknow, India, 226030
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Mumbai, India, 400012
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Mumbai, India, 400053
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Mumbai, India, 400 078
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Mysuru, India, 570004
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New Delhi, India, 110060
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Puducherry, India, 605006
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Secunderabad, India, 500003
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Afula, Israel, 18101
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Haifa, Israel, 34362
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Haifa, Israel, 31048
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 4428164
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Ramat Gan, Israel, 52621
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Ancona, Italia, 60126
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Bari, Italia, 70124
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Catania, Italia, 95100
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Milan, Italia, 20132
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Milan, Italia, 20161
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Padova, Italia, 35128
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Palermo, Italia, 90127
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Pavia, Italia, 27100
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Pisa, Italia, 56126
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Roma, Italia, 00161
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Roma, Italia, 00189
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Roma, Italia, 00128
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Rozzano, Italia, 20089
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Siena, Italia, 53100
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Asahikawa-Shi, Japan, 070-8644
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Bunkyō City, Japan, 113-8431
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Bunkyō City, Japan, 113-8603
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Chiba, Japan, 260-0877
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Fukuoka, Japan, 810-8563
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Hiroshima, Japan, 734-8551
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Iruma-Gun, Japan, 350-0495
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Kawachinagano-shi, Japan, 586-8521
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Kawasaki-shi, Japan, 216-8511
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Nagoya, Japan, 457-0866
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Nagoya, Japan, 467-0001
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Okayama, Japan, 700-8557
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Omura-shi, Japan, 856-8562
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Sendai, Japan, 980-8574
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Shinjuku-ku, Japan, 160-8582
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Tachikawa-shi, Japan, 190-0014
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Yotsukaido-shi, Japan, 284-0003
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Beijing, Kina, 100191
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Beijing, Kina, 100029
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Beijing, Kina, CN-100730
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Beijing, Kina, 100044
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Chongqing, Kina, 402260
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Dongguan, Kina, 523009
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Guangzhou, Kina, 510630
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Guangzhou, Kina, 510317
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Hangzhou, Kina, 310014
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Hengyang, Kina, 421001
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Jining, Kina, 272011
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Nanjing, Kina, 210029
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Shanghai, Kina, 200025
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Shanghai, Kina, 200032
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Shanghai, Kina, 200040
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Shanghai, Kina
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Shijiazhuang, Kina, 050001
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Wenzhou, Kina, 325000
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Zhengzhou, Kina, 450052
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Culiacán, Mexico, 80020
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D.F, Mexico, 14000
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Guadalajara, Mexico, 44650
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Guadalajara, Mexico, 44600
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Guadalajara, Mexico, 44690
- Rekruttering
- Research Site
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Mexico City, Mexico, 03310
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Mexico City, Mexico, 06700
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México, Mexico, 06090
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México, Mexico, 11850
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Amsterdam, Nederland, 1105 AZ
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Bialystok, Polen, 15-276
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Krakow, Polen, 30-002
- Rekruttering
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Krakow, Polen, 30-105
- Rekruttering
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Lodz, Polen, 90-549
- Rekruttering
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Poznan, Polen, 61-545
- Rekruttering
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Poznan, Polen, 60-218
- Suspendert
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Warsaw, Polen, 02-637
- Rekruttering
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Warsaw, Polen, 00-874
- Rekruttering
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Wroclaw, Polen, 50-556
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Caguas, Puerto Rico, 00725
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San Juan, Puerto Rico, 00918
- Rekruttering
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A Coruña, Spania, 15006
- Suspendert
- Research Site
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Barcelona, Spania, 08041
- Rekruttering
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Barcelona, Spania, 08003
- Rekruttering
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Barcelona, Spania, 08035
- Tilbaketrukket
- Research Site
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Córdoba, Spania, 14004
- Rekruttering
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L'Hospitalet de Llobregat, Spania, 08907
- Rekruttering
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Madrid, Spania, 28041
- Rekruttering
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Madrid, Spania, 28034
- Tilbaketrukket
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Sabadell, Spania, 08208
- Rekruttering
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Valladolid, Spania, 47012
- Rekruttering
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Edinburgh, Storbritannia, EH4 2XU
- Rekruttering
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London, Storbritannia, NW3 2QG
- Rekruttering
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Wolverhampton, Storbritannia, WV10 0QP
- Rekruttering
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Stockholm, Sverige, 171 76
- Tilbaketrukket
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Uppsala, Sverige, 751 85
- Rekruttering
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Daejeon, Sør -Korea, 35015
- Rekruttering
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Seoul, Sør -Korea, 06591
- Rekruttering
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Seoul, Sør -Korea, 02447
- Rekruttering
- Research Site
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Seoul, Sør -Korea, 04401
- Rekruttering
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Seoul, Sør -Korea, 133792
- Rekruttering
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Kaohsiung City, Taiwan, 833
- Rekruttering
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Kaohsiung City, Taiwan, 81362
- Rekruttering
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New Taipei City, Taiwan, 220
- Tilbaketrukket
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Taichung, Taiwan, 40705
- Rekruttering
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Taichung, Taiwan, 40447
- Avsluttet
- Research Site
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Taipei, Taiwan, 112
- Tilbaketrukket
- Research Site
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Taoyuan, Taiwan, 333
- Tilbaketrukket
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Prague, Tsjekkia, 12850
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Bad Nauheim, Tyskland, 61231
- Tilbaketrukket
- Research Site
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Berlin, Tyskland, 10117
- Aktiv, ikke rekrutterende
- Research Site
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Bonn, Tyskland, 53127
- Rekruttering
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Freiburg im Breisgau, Tyskland, 79106
- Rekruttering
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Herne, Tyskland, 44649
- Tilbaketrukket
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München, Tyskland, 80336
- Rekruttering
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Tübingen, Tyskland, 72076
- Rekruttering
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Budapest, Ungarn, 1023
- Har ikke rekruttert ennå
- Research Site
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Debrecen, Ungarn, 4032
- Rekruttering
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Szeged, Ungarn, 6725
- Rekruttering
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Hanoi, Vietnam, 100000
- Rekruttering
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Hanoi, Vietnam, 10000
- Tilbaketrukket
- Research Site
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Ho Chi Minh City, Vietnam, 700000
- Rekruttering
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Ho Chi Minh City, Vietnam, 700000
- Tilbaketrukket
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Hochiminh City, Vietnam, 700000
- Tilbaketrukket
- Research Site
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Huế, Vietnam, 530000
- Rekruttering
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Hà Nội, Vietnam, 100000
- Rekruttering
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Hà Nội, Vietnam, 100000
- Tilbaketrukket
- Research Site
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Hồ Chí Minh, Vietnam, 700000
- Rekruttering
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Graz, Østerrike, 8036
- Rekruttering
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Vienna, Østerrike, 1090
- Rekruttering
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Capable of giving informed consent.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 .
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly |
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Andre navn:
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Andre navn:
|
|
Placebo komparator: Placebo (subcutaneous weekly injection)
Matched placebo control subcutaneous injection once weekly |
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Improvement Score (TIS) ≥ 40 response
Tidsramme: 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 |
52 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Manual Muscle Testing 8 (MMT-8) (CSM)
Tidsramme: 52 week
|
MMT-8 (CSM) change from baseline at Week 52. |
52 week
|
|
Oral corticosteroid dose ≤ 7.5 mg/day
Tidsramme: 52 week
|
Participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52. |
52 week
|
|
Moderate improvement in disease activity in participants with polymyositis (PM)
Tidsramme: 52 week
|
Participants with PM who have at least moderate improvement in disease activity (TIS ≥ 40) at Week 52. |
52 week
|
|
Moderate improvement in disease activity in dermatomyositis (DM) participants.
Tidsramme: 52 week
|
Participants with DM who have at least moderate improvement in disease activity (TIS ≥ 40). |
52 week
|
|
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Tidsramme: 8 week
|
CDASI activity change from baseline at Week 8 in DM participants only. |
8 week
|
|
Manual Muscle Testing 8 (MMT-8) in PM participants
Tidsramme: 52 Week
|
MMT-8 change from baseline at Week 52 in PM participants only. |
52 Week
|
|
Manual Muscle Testing 8 (MMT-8) in DM participants
Tidsramme: 52 Week
|
MMT-8 change from baseline at Week 52 in DM participants only. |
52 Week
|
|
Core Set Measures (CSMs)
Tidsramme: 52 week
|
Change from baseline at Week 52 in CSMs:
|
52 week
|
|
Oral corticosteroid dose ≤ 7.5 mg/day in PM participants
Tidsramme: 52 week
|
PM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52 |
52 week
|
|
Oral corticosteroid dose ≤ 7.5 mg/day in DM participants
Tidsramme: 52 week
|
DM participants who achieve oral corticosteroid dose ≤ 7.5 mg/day at Week 52. |
52 week
|
|
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
Tidsramme: 8, 24, & 52 week
|
DM Participants with CDA-IGA ≥ 2 at baseline who achieve:
|
8, 24, & 52 week
|
|
5-D itch
Tidsramme: 8, 24, & 52 week
|
DM participants with CDASI activity > 14 at baseline only:
|
8, 24, & 52 week
|
|
Total Improvement Score (TIS) ≥ 20 Response
Tidsramme: 8 week
|
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 |
8 week
|
|
Total Improvement Score ≥ 60 Response
Tidsramme: 52 week
|
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 |
52 week
|
|
Cumulative Corticosteroid Use
Tidsramme: 24, 52 week
|
|
24, 52 week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
20. juni 2024
Primær fullføring (Antatt)
10. januar 2028
Studiet fullført (Antatt)
9. april 2029
Datoer for studieregistrering
Først innsendt
28. september 2023
Først innsendt som oppfylte QC-kriteriene
11. juni 2024
Først lagt ut (Faktiske)
12. juni 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D3463C00003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Tilgangskriterier for IPD-deling
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-deling Støtteinformasjonstype
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .