Stanovení účinnosti anifrolumabu u SYSTÉMOVÉ sklerózy (DAISY) (DAISY)
Multicentrická, randomizovaná, paralelně skupinová, dvojitě zaslepená, dvouramenná studie fáze III k vyhodnocení bezpečnosti a účinnosti anifrolumabu ve srovnání s placebem u mužských a ženských účastníků ve věku 18 až 70 let včetně se systémovou sklerózou
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
This is a multicenter, randomized, double-blind, placebo-controlled, Phase III study to evaluate the efficacy and safety of anifrolumab in the treatment of adult participants with Systemic Sclerosis (SSc) who may be taking one or a combination of protocol-specified standard therapies. The use of one of the following standard immunosuppressant therapies is permitted at a stable dose, but not mandated: hydroxychloroquine, mycophenolate mofetil (MMF), mycophenolic acid or mycophenolate sodium (MPA/MPS), methotrexate, azathioprine, tacrolimus, and oral glucocorticoids. MMF or MPA/MPS, azathioprine, and methotrexate may be used in combination with hydroxychloroquine and/or low-dose oral glucocorticoids [≤ 10 mg/day].
Approximately 306 eligible participants will be randomized in a 1:1 ratio to receive either anifrolumab (or matching placebo) given subcutaneously once weekly for 52 weeks. The study will be stratified by the following factors:
- Interstitial lung disease (ILD) (yes, no) at Week 0 (Day1);
- MMF or MPA/MPS use (yes ,no) at Week 0 (Day 1); and
- Disease duration, defined as the time from the first non-Raynaud's symptom attributable to SSc (<18 months, ≥ 18 months) at Week 0 (Day 1)
Study treatment will be administered subcutaneously via an accessorized prefilled syringe by study staff or by the participant or carer, either in the clinic or at home, with most doses being administered at home. The study consists of 4 periods: a 6-week screening period, a 52-week, double-blind, placebo-controlled period, a 52-week open-label active treatment period, and a 12-week safety follow-up period. There are a total of 16 study visits with most visits in the treatment period occurring every 8 to 12 weeks. The periods are described below:
- Screening Period: This may involve one or more visits to the study site.
- Double Blind Treatment Period: Treatment Period when participants will receive once weekly injections of anifrolumab or matching placebo. Participation will involve in-clinic study visits at Weeks 0 (Day 1), 1, 4, 8*, 16, 24, 36, 48 and 52. *The visit at Week 8 may be either by telephone or in person.
- Open Label Treatment Period: At Week 52, all participants will be given anifrolumab (subcutaneous) once weekly for 52 weeks (last dose at Week 103). Participation will involve in-clinic study visits at Weeks 52, 53*, 56, 64, 76. 88 and 104. *The visit at Week 53 may be either by telephone or in person.
- Safety Follow-up Period: All participants will return to the clinic for a 12-week post treatment visit. This will occur post Double Blind Treatment Period (Week 52 or Double Blind Period early discontinuation) or post Open Label Treatment Period (Week 104 or Open Label Period early discontinuation).
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Ghent, Belgie, B-9000
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Leuven, Belgie, 3000
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Bordeaux, Francie, 33076
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Brest, Francie, 29609
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Paris, Francie, 75020
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Paris, Francie, 75679
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Rennes, Francie, 35033
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Strasbourg, Francie, 67098
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Toulouse, Francie, 31059
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Groningen, Holandsko, 9713 GZ
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Ahmedabad, Indie, 380006
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Delhi, Indie, 110060
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Gurugram, Indie, 122001
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Hyderabad, Indie, 500082
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Kolkata, Indie, 700020
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Mumbai, Indie, 400053
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Mysuru, Indie, 570004
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New Delhi, Indie, 11029
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Pune, Indie, 411001
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Secunderabad, Indie, 500003
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Ancona, Itálie, 60126
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Brescia, Itálie, 25123
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Cona, Itálie, 44124
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Milan, Itálie, 20122
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Padova, Itálie, 35128
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Roma, Itálie, 00168
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Roma, Itálie, 00128
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Roma, Itálie, 161
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Afula, Izrael, 18101
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Haifa, Izrael, 31096
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Haifa, Izrael, 31048
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Jerusalem, Izrael, 00000
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Kfar Saba, Izrael, 4428164
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Ramat Gan, Izrael, 52621
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Bunkyō City, Japonsko, 113-8603
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Fukuoka, Japonsko, 812-8582
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Iruma-Gun, Japonsko, 350-0495
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Kanazawa, Japonsko, 920-8641
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Maebashi, Japonsko, 371-8511
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Nagasaki, Japonsko, 852-8501
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Nagoya, Japonsko, 457-0866
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Sapporo, Japonsko, 060-8638
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Sendai, Japonsko, 980-8574
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Shinjuku-ku, Japonsko, 160-8582
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Suita-shi, Japonsko, 565-0871
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Takatsuki-shi, Japonsko, 569-8686
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Toyoake-shi, Japonsko, 470-1192
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Yokohama, Japonsko, 236-0004
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Parktown, Jižní Afrika, 2193
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Pretoria, Jižní Afrika, 0083
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Busan, Jižní Korea, 49241
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Seoul, Jižní Korea, 03080
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Seoul, Jižní Korea, 04763
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Seoul, Jižní Korea, 04401
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Seoul, Jižní Korea, 137-701
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
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Ontario
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Toronto, Ontario, Kanada, M5T 3L9
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Quebec
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Montreal, Quebec, Kanada, H4J 1C5
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Montreal, Quebec, Kanada, H3T 1E2
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Québec, Quebec, Kanada, G1V 4K5
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Kuala Lumpur, Malajsie, 59100
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Kuching, Malajsie, 93586
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Seremban, Malajsie, 70300
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Budapest, Maďarsko, 1027
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Budapest, Maďarsko, 1023
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Budapest, Maďarsko, 1138
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Debrecen, Maďarsko, 4032
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Pécs, Maďarsko, 7632
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Szeged, Maďarsko, 6725
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Chihuahua City, Mexiko, 31000
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Guadalajara, Mexiko, 44650
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Guadalajara, Mexiko, 44158
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Mexico City, Mexiko, 06700
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San Luis Potosí City, Mexiko, 78250
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San Luis Potosí City, Mexiko, 78213
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Freiburg im Breisgau, Německo, 79106
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Mainz, Německo, 55131
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Minden, Německo, 32429
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Münster, Německo, 48149
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Tübingen, Německo, 72076
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Bydgoszcz, Polsko, 85-168
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Krakow, Polsko, 30-002
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Krakow, Polsko, 30-105
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Lodz, Polsko, 90-549
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Sosnowiec, Polsko, 41-200
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Warsaw, Polsko, 00-874
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Graz, Rakousko, 8036
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Innsbruck, Rakousko, 6020
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Vienna, Rakousko, 1090
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Bucharest, Rumunsko, 011172
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Bucharest, Rumunsko, 020475
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Cluj-Napoca, Rumunsko, 400006
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Iași, Rumunsko, 700661
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Cannock, Spojené království, WS11 2XY
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Leeds, Spojené království, LS7 4SA
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London, Spojené království, NW3 2QG
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Sheffield, Spojené království, S10 2JF
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Arizona
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Scottsdale, Arizona, Spojené státy, 85259
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California
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Chula Vista, California, Spojené státy, 91910
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Los Angeles, California, Spojené státy, 90095
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Orange, California, Spojené státy, 92868
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Colorado
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Aurora, Colorado, Spojené státy, 80045
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Connecticut
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New Haven, Connecticut, Spojené státy, 06519
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20007
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Florida
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Boca Raton, Florida, Spojené státy, 33486
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Fort Lauderdale, Florida, Spojené státy, 33309
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Gainesville, Florida, Spojené státy, 32603
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Jacksonville, Florida, Spojené státy, 32216
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Margate, Florida, Spojené státy, 33063
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South Miami, Florida, Spojené státy, 33143
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Tamarac, Florida, Spojené státy, 33321
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Illinois
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Chicago, Illinois, Spojené státy, 60611
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Kansas
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Kansas City, Kansas, Spojené státy, 66160
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70121
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Maryland
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Baltimore, Maryland, Spojené státy, 21224
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905
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New York
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Babylon, New York, Spojené státy, 11702
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New York, New York, Spojené státy, 10032
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
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Texas
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Allen, Texas, Spojené státy, 75013
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Houston, Texas, Spojené státy, 77030
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Ankara, Turecko (Türkiye), 06100
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Ankara, Turecko (Türkiye), 06230
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Antalya, Turecko (Türkiye), 07059
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Center, Turecko (Türkiye), 23200
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Kazımkarabekir, Turecko (Türkiye), 01230
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Kocaeli, Turecko (Türkiye), 41380
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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, 70000
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Hochiminh, Vietnam, 70000
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Hà Nội, Vietnam, 100000
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Beijing, Čína, 100191
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Beijing, Čína, CN-100730
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Guangzhou, Čína, 510100
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Guangzhou, Čína, 510530
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Hangzhou, Čína, 310014
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Lanzhou, Čína, 730000
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Shanghai, Čína, 200032
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Shanghai, Čína, 201210
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Tianjin, Čína, 300050
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A Coruña, Španělsko, 15006
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Barcelona, Španělsko, 08041
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Barcelona, Španělsko, 08003
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Madrid, Španělsko, 28041
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Málaga, Španělsko, 29009
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Valencia, Španělsko, 46026
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Valencia, Španělsko, 46017
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Key Inclusion Criteria:
- Adult patients from 18 to 70 years of age inclusive
- Systemic sclerosis according to 2013 ACR/EULAR classification criteria
- Limited or diffuse cutaneous subsets
- Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
- Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
- mRSS > 10 with early disease or rapid progression as defined by the protocol
- mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
- Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
- Women of childbearing potential with a negative urine pregnancy test
- Uninvolved skin at injection sites
Key Exclusion Criteria:
- Anticentromere antibody seropositivity on central laboratory
- Severe cardiopulmonary disease as defined by the protocol
- History of systemic sclerosis renal crisis within past 12 months (estimated glomerular filtration rate(eGFR) < 45 mL/min/1.73m2)
- Overlap syndromes, systemic lupus erythematosus with anti-double-stranded deoxyribonucleic acid antibody seropositivity or anti-citrullinated protein antibodies-positive rheumatoid arthritis, or SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)
- History of, or current, any other inflammatory diseases, eg, inflammatory bowel disease, skin disease, that, in the opinion of the investigator, could interfere with efficacy and safety assessments or require immunomodulatory therapy
- Evidence of moderately severe concurrent nervous system, renal, endocrine, hepatic (eg, underlying chronic liver disease [Child Pugh A, B, C hepatic impairment]), or gastrointestinal disease (eg, clinical signs of malabsorption or needing parenteral nutrition) not related to SSc, as determined by the investigator
- Hematopoietic stem cell transplantation or solid organ/limb transplantation
- Any severe case of Herpes Zoster infection as defined by the protocol
- Known malignancy or a history of malignancy within 5 years, with exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
- Major surgery within 8 weeks prior to and/or during study enrollment
- Known active current or history of recurrent infections
- Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with the efficacy or safety evaluation of the study intervention or put participant at safety risk
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly |
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks
Ostatní jména:
At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks
Ostatní jména:
|
|
Komparátor placeba: matched placebo control (subcutaneous weekly injection)
matched placebo control subcutaneous injection once weekly |
matched placebo delivered subcutaneously, once weekly for 52 weeks
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of participants responding to treatment based on the Revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Časové okno: at Week 52
|
Number of participants meeting all the criteria:
New scleroderma renal crisis New decline in percent predicted FVC≥15% in established interstitial lung disease or new percent predicted FVC below 80% predicted New onset of left ventricular failure requiring treatment New onset of pulmonary arterial hypertension requiring treatment Gastrointestinal dysmotility requiring enteral or parenteral nutrition Digital ischemia with gangrene, amputation, or hospitalization requiring treatment -Otherwise, a participant is a non-responder |
at Week 52
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from baseline in mRSS
Časové okno: at Week 52
|
Change from baseline in mRSS score. The mRSS scoring ranges from 0 (normal) to 51 (severe). |
at Week 52
|
|
Number of patients with improvement in individual revised Composite Response Index in Systemic Sclerosis (CRISS-25)
Časové okno: at Week 52
|
Number of participants who have improvements in the following improvement components, evaluated separately:
|
at Week 52
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Change from baseline in chest computed tomography imaging
Časové okno: at Week 52
|
Change from baseline in quantitative interstitial lung disease score |
at Week 52
|
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Change from baseline in Scleroderma Skin Patient Reported Outcome
Časové okno: at Week 52
|
Change from baseline in the Scleroderma Skin Patient Reported Outcome scores |
at Week 52
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Change from baseline in FVC
Časové okno: at Week 52
|
|
at Week 52
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Change from baseline in percent predicted FVC
Časové okno: at Week 52
|
|
at Week 52
|
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Anifrolumab pharmacokinetic parameters in serum
Časové okno: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
|
Anifrolumab serum concentrations will be summarised using descriptive statistics at each visit. Due to sparse pharmacokinetic sampling, the pharmacokinetic assessment will be primarily based on observed serum trough concentrations (Ctrough) |
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
|
|
Anifrolumab pharmacodynamics via changes in type I IFN 21-gene signature generated from blood
Časové okno: Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104
|
Type I Interferon inducible gene signature will be assessed by a 21-gene assay in whole blood. The suppression of the type I IFN 21-gene signature will be showed as a percent of baseline through study completion, during both the double-blind treatment and open label periods. |
Double-blind treatment period: pre-dose (Day 1) Weeks 4, 16, 24, 52; open-label period: weeks 56, 76 and 104
|
|
Prevalence of anti-drug antibodies to Anifrolumab
Časové okno: Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
|
Anti-drug antibodies and titer determination in anti-drug antibody positive participants. The presence of neutralizing anti-drug antibodies will also be tested in all anti-drug positive samples. |
Weeks 4, 16, 24, 36, 52, 56, 76, and 104 to follow-up (max 116 weeks)
|
|
Incidence of adverse events
Časové okno: From screening to follow-up (max 126 weeks)
|
Adverse events (non-serious, serious, and adverse event of special interest (AESI)) are assessed as variables of safety and tolerability of anifrolumab. The AESIs are non-opportunistic serious infections, opportunistic infections, malignancy, herpes zoster, Tuberculosis (TB) (including latent TB), injection site reactions, and major adverse cardiac events. |
From screening to follow-up (max 126 weeks)
|
|
Incidence of abnormal vital signs
Časové okno: From screening to follow-up (max 126 weeks)
|
Change from baseline of pulse rate, blood pressure, respiration rate, and body temperature will be assessed by visit and treatment group including participants with treatment-emergent changes. |
From screening to follow-up (max 126 weeks)
|
|
Incidence of abnormal laboratory parameters
Časové okno: From screening to follow-up (max 126 weeks)
|
Changes from baseline in haematology, clinical chemistry and lipid variables will be assessed by visit and treatment including participants with treatment-emergent changes. |
From screening to follow-up (max 126 weeks)
|
|
Incidence of abnormal ECG findings
Časové okno: From screening to end of treatment visit (max 110 weeks)
|
Observed values of heart rate, QRS duration, PR interval, RR interval and QT interval will be summarised by visit and treatment group including participants with clinically significant abnormal results. |
From screening to end of treatment visit (max 110 weeks)
|
|
Incidence of abnormal physical exam findings
Časové okno: From screening to follow-up (max 126 weeks)
|
Changes from baseline in weight (kilograms) will be assessed by visit and treatment and medically significant changes from the screening physical examination will be recorded as adverse events. |
From screening to follow-up (max 126 weeks)
|
|
Number of subjects with suicidal ideation and behavior and suicide attempts via Columbia-Suicide Severity Rating Scale (C-SSRS)
Časové okno: From screening to follow-up (max 126 weeks)
|
The C-SSRS is used to assess suicidal ideation, behavior, and suicide on a graded scale from 1 to 5. 1 indicates as low suicidal and 5 as high suicidal behavior. |
From screening to follow-up (max 126 weeks)
|
|
Total score of Personal Health Questionnaire Depression Scale-8 (PHQD-8)
Časové okno: From screening to follow-up (max 126 weeks)
|
PHQ-8 is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQD-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. |
From screening to follow-up (max 126 weeks)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- D3460C00002
- 2023-505976-31 (Jiný identifikátor: EuCTR)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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 AstraZeneca disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AstraZeneca group of companies sponsored clinical trials are accepting requests for IPD, but this does not mean all requests will be shared.
Časový rámec sdílení IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. The timelines vary per request and can take up to a year upon full submission of the request for analysis, decision, anonymisation and sharing of the requested data or documents. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Kritéria přístupu pro sdílení IPD
When a request has been approved, AstraZeneca will provide access to the deidentified 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .