En undersøgelse for at undersøge effektiviteten og sikkerheden af anifrolumab administreret som subkutan injektion og tilføjet til standardbehandling sammenlignet med placebo tilføjet til standardbehandling hos voksne deltagere med idiopatiske inflammatoriske myopatier (polymyositis og dermatomyositis) (JASMINE)
23. september 2026 opdateret af: AstraZeneca
Et multicenter, parallelgruppe, dobbeltblindt, 2-arm, fase III-studie for at undersøge effektiviteten og sikkerheden af anifrolumab administreret som subkutan injektion og tilføjet til standardbehandling sammenlignet med placebo tilføjet til standardbehandling hos voksne deltagere med idiopatisk inflammatorisk Myopatier (polymyositis og dermatomyositis)
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
240
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: 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, Australien, 2050
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Nedlands, Australien, 6009
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New Lambton, Australien, 2310
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Southport, Australien, 4222
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Woodville South, Australien, 5011
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Ghent, Belgien, 9000
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Leuven, Belgien, 3000
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Merksem, Belgien, B-2170
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Joinville, Brasilien, 89202-190
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Juiz de Fora, Brasilien, 36010 570
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Pelotas, Brasilien, 96040-010
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Porto Alegre, Brasilien, 90620-110
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Salvador, Brasilien, 41253-190
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Salvador, Brasilien, 40150-150
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São José do Rio Preto, Brasilien, 15090-000
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São Paulo, Brasilien, 01233-907
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São Paulo, Brasilien, 5403-000
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Haskovo, Bulgarien, 6304
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Plovdiv, Bulgarien, 4002
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Plovdiv, Bulgarien, 4002
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Plovdiv, Bulgarien, 4001
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Rousse, Bulgarien, 7000
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Sofia, Bulgarien, 1680
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Stara Zagora, Bulgarien, 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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Edinburgh, Det Forenede Kongerige, EH4 2XU
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London, Det Forenede Kongerige, NW3 2QG
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
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Arizona
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Phoenix, Arizona, Forenede Stater, 85032
- Ikke rekrutterer endnu
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California
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Irvine, California, Forenede Stater, 92617
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Denver, Colorado, Forenede Stater, 80230
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20037
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
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Boynton Beach, Florida, Forenede Stater, 33472
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Gainesville, Florida, Forenede Stater, 32603
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Margate, Florida, Forenede Stater, 33063
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Miami, Florida, Forenede Stater, 33126
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Miami, Florida, Forenede Stater, 33133
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Orlando, Florida, Forenede Stater, 32819
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Palm Beach Gardens, Florida, Forenede Stater, 33410
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Plant City, Florida, Forenede Stater, 33563
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
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Illinois
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Willowbrook, Illinois, Forenede Stater, 60527
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Kansas
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Fairway, Kansas, Forenede Stater, 66205
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
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Sterling Heights, Michigan, Forenede Stater, 48313
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New York
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Great Neck, New York, Forenede Stater, 11021
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28207
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Charlotte, North Carolina, Forenede Stater, 28211
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Durham, North Carolina, Forenede Stater, 27710
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
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Middleburg Heights, Ohio, Forenede Stater, 44130
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Ikke rekrutterer endnu
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
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Summerville, South Carolina, Forenede Stater, 29486
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Texas
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Allen, Texas, Forenede Stater, 75013
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Amarillo, Texas, Forenede Stater, 79124
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Austin, Texas, Forenede Stater, 78759
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Colleyville, Texas, Forenede Stater, 76034
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El Paso, Texas, Forenede Stater, 79902
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Galveston, Texas, Forenede Stater, 77555
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Harlingen, Texas, Forenede Stater, 78550
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Houston, Texas, Forenede Stater, 77030
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North Richland Hills, Texas, Forenede Stater, 76180
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West Virginia
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Beckley, West Virginia, Forenede Stater, 25801
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
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Angers, Frankrig, 49033
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Brest, Frankrig, 29609
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Le Mans, Frankrig, 72037
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Lille, Frankrig, 59037
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Lyon, Frankrig, 69437
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Paris, Frankrig, 75010
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Paris, Frankrig, 75651
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Reims, Frankrig, 51100
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Rouen, Frankrig, 76000
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Strasbourg, Frankrig, 67098
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Toulouse, Frankrig, 31059
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Amsterdam, Holland, 1105 AZ
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Ahmedabad, Indien, 380006
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Ahmedabad, Indien, 382421
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Bangalore, Indien, 560079
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Dehradun, Indien, 248016
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Delhi, Indien, 110029
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Gurugram, Indien, 122001
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Hyderabad, Indien, 500082
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Kolkata, Indien, 700020
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Lucknow, Indien, 226030
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Mumbai, Indien, 400012
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Mumbai, Indien, 400053
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Mumbai, Indien, 400 078
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Mysuru, Indien, 570004
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New Delhi, Indien, 110060
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Puducherry, Indien, 605006
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Secunderabad, Indien, 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, Italien, 60126
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Bari, Italien, 70124
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Catania, Italien, 95100
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Milan, Italien, 20132
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Milan, Italien, 20161
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Padova, Italien, 35128
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Palermo, Italien, 90127
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Pavia, Italien, 27100
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Pisa, Italien, 56126
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Roma, Italien, 00161
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Roma, Italien, 00189
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Roma, Italien, 00128
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Rozzano, Italien, 20089
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Siena, Italien, 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
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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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Bialystok, Polen, 15-276
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Krakow, Polen, 30-002
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Krakow, Polen, 30-105
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Lodz, Polen, 90-549
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Poznan, Polen, 61-545
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Poznan, Polen, 60-218
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Warsaw, Polen, 02-637
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Warsaw, Polen, 00-874
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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
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A Coruña, Spanien, 15006
- Suspenderet
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Barcelona, Spanien, 08041
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Barcelona, Spanien, 08003
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Barcelona, Spanien, 08035
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Córdoba, Spanien, 14004
- Rekruttering
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L'Hospitalet de Llobregat, Spanien, 08907
- Rekruttering
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Madrid, Spanien, 28041
- Rekruttering
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Madrid, Spanien, 28034
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Sabadell, Spanien, 08208
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Valladolid, Spanien, 47012
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Stockholm, Sverige, 171 76
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Uppsala, Sverige, 751 85
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Daejeon, Sydkorea, 35015
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Seoul, Sydkorea, 06591
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Seoul, Sydkorea, 02447
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Seoul, Sydkorea, 04401
- Rekruttering
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Seoul, Sydkorea, 133792
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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
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 40447
- Afsluttet
- Research Site
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Taipei, Taiwan, 112
- Trukket tilbage
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Taoyuan, Taiwan, 333
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Prague, Tjekkiet, 12850
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Bad Nauheim, Tyskland, 61231
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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
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München, Tyskland, 80336
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Tübingen, Tyskland, 72076
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Budapest, Ungarn, 1023
- Ikke rekrutterer endnu
- Research Site
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Debrecen, Ungarn, 4032
- Rekruttering
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Szeged, Ungarn, 6725
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Hanoi, Vietnam, 100000
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Hanoi, Vietnam, 10000
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Ho Chi Minh City, Vietnam, 700000
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Ho Chi Minh City, Vietnam, 700000
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Hochiminh City, Vietnam, 700000
- Trukket tilbage
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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
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Hồ Chí Minh, Vietnam, 700000
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Graz, Østrig, 8036
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Vienna, Østrig, 1090
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly |
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Andre navne:
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Andre navne:
|
|
Placebo komparator: Placebo (subcutaneous weekly injection)
Matched placebo control subcutaneous injection once weekly |
Matched placebo delivered subcutaneously, once weekly for 52 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juni 2024
Primær færdiggørelse (Anslået)
10. januar 2028
Studieafslutning (Anslået)
9. april 2029
Datoer for studieregistrering
Først indsendt
28. september 2023
Først indsendt, der opfyldte QC-kriterier
11. juni 2024
Først opslået (Faktiske)
12. juni 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D3463C00003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
IPD-delingsadgangskriterier
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 Understøttende informationstype
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .