Eine Studie zur Bewertung der Wirksamkeit und Sicherheit von Dapirolizumab Pegol bei Studienteilnehmern mit mäßig bis schwer aktivem systemischem Lupus erythematodes (PHOENYCS FLY)
Eine multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelgruppenstudie zur Bewertung der Wirksamkeit und Sicherheit von Dapirolizumab Pegol bei Studienteilnehmern mit mäßig bis schwer aktivem systemischem Lupus erythematodes
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: UCB Cares
- Telefonnummer: 001 844 599 2273
Studieren Sie die Kontaktsicherung
- Name: UCB Cares
- Telefonnummer: 1-844-599-2273
- E-Mail: ucbcares@ucb.com
Studienorte
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C.a.b.a, Argentinien
- Rekrutierung
- Sl0044 60004
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Capital Federal, Argentinien
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- Sl0044 60002
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Córdoba, Argentinien
- Rekrutierung
- Sl0044 60024
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Mendoza, Argentinien
- Rekrutierung
- Sl0044 60029
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Quilmes, Argentinien
- Rekrutierung
- Sl0044 60003
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San Juan, Argentinien
- Rekrutierung
- Sl0044 60011
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San Miguel de Tucumán, Argentinien
- Rekrutierung
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Leuven, Belgien
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Liège, Belgien
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- Sl0044 40060
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Santiago, Chile
- Rekrutierung
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Baotou, China
- Rekrutierung
- Sl0044 20293
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Beijing, China
- Rekrutierung
- Sl0044 20157
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Beijing, China
- Rekrutierung
- Sl0044 20173
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Beijing, China
- Rekrutierung
- Sl0044 20128
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Bengbu, China
- Rekrutierung
- Sl0044 20201
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Changchun, China
- Rekrutierung
- Sl0044 20291
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Changchun, China
- Rekrutierung
- Sl0044 20342
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Changsha, China
- Rekrutierung
- Sl0044 20295
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Changzhou, China
- Rekrutierung
- Sl0044 20186
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Chengdu, China
- Rekrutierung
- Sl0044 20137
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Guangzhou, China
- Rekrutierung
- Sl0044 20019
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Guangzhou, China
- Rekrutierung
- Sl0044 20360
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Guilin, China
- Rekrutierung
- Sl0044 20290
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Haikou, China
- Rekrutierung
- Sl0044 20271
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Hangzhou, China
- Rekrutierung
- Sl0044 20296
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Jinan, China
- Rekrutierung
- Sl0044 20185
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Jiujiang, China
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Nanchang, China
- Rekrutierung
- Sl0044 20192
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Nanjing, China
- Rekrutierung
- Sl0044 20024
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Nanning, China
- Rekrutierung
- Sl0044 20331
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Pingxiang, China
- Rekrutierung
- Sl0044 20272
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Shanghai, China
- Rekrutierung
- Sl0044 20172
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Shanghai, China
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Shantou, China
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Shijiazhuang, China
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Suzhou, China
- Rekrutierung
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Tianjin, China
- Rekrutierung
- Sl0044 20136
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Urumuqi, China
- Rekrutierung
- Sl0044 20275
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Wenzhou, China
- Rekrutierung
- Sl0044 20025
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Wuhan, China
- Rekrutierung
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Wuhan, China
- Rekrutierung
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Xi'an, China
- Rekrutierung
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Xiamen, China
- Rekrutierung
- Sl0044 20341
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Yangzhou, China
- Rekrutierung
- Sl0044 20273
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Zhengzhou, China
- Aktiv, nicht rekrutierend
- Sl0044 20132
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Zhuzhou, China
- Rekrutierung
- Sl0044 20361
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Berlin, Deutschland
- Rekrutierung
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Cologne, Deutschland
- Rekrutierung
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Cologne, Deutschland
- Rekrutierung
- Sl0044 40716
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Dessau, Deutschland
- Zurückgezogen
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Dresden, Deutschland
- Rekrutierung
- Sl0044 40356
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Freiburg im Breisgau, Deutschland
- Rekrutierung
- Sl0044 40072
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Greifswald, Deutschland
- Rekrutierung
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Herne, Deutschland
- Rekrutierung
- Sl0044 40027
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Jena, Deutschland
- Aktiv, nicht rekrutierend
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Leipzig, Deutschland
- Rekrutierung
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Mainz, Deutschland
- Rekrutierung
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München, Deutschland
- Rekrutierung
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Tübingen, Deutschland
- Rekrutierung
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Vogelsang-gommern, Deutschland
- Rekrutierung
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Aalborg, Dänemark
- Rekrutierung
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Aarhus, Dänemark
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Copenhagen, Dänemark
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Odense, Dänemark
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Bordeaux, Frankreich
- Rekrutierung
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Le Mans, Frankreich
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Montpellier, Frankreich
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Athens, Griechenland
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- Sl0044 40376
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Athens, Griechenland
- Rekrutierung
- Sl0044 40501
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Heraklion, Griechenland
- Rekrutierung
- Sl0044 40377
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Larissa, Griechenland
- Rekrutierung
- Sl0044 40507
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Brescia, Italien
- Rekrutierung
- Sl0044 40816
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Genova, Italien
- Rekrutierung
- Sl0044 40514
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Milan, Italien
- Rekrutierung
- Sl0044 40291
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Milan, Italien
- Rekrutierung
- Sl0044 40471
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Monza E Brianza, Italien
- Rekrutierung
- Sl0044 40859
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Padova, Italien
- Rekrutierung
- Sl0044 40509
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Pisa, Italien
- Rekrutierung
- Sl0044 40176
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Roma, Italien
- Rekrutierung
- Sl0044 40148
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Roma, Italien
- Rekrutierung
- Sl0044 40675
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Roma, Italien
- Rekrutierung
- Sl0044 40860
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Roma, Italien
- Rekrutierung
- Sl0044 40897
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Rozzano, Italien
- Rekrutierung
- Sl0044 40830
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Udine, Italien
- Rekrutierung
- Sl0044 40817
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Bunkyō City, Japan
- Rekrutierung
- Sl0044 20035
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Bunkyō City, Japan
- Rekrutierung
- Sl0044 20196
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Bunkyō City, Japan
- Rekrutierung
- Sl0044 20279
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Chūōku, Japan
- Rekrutierung
- Sl0044 20030
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Fukuoka, Japan
- Rekrutierung
- Sl0044 20281
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Kawagoe, Japan
- Rekrutierung
- Sl0044 20039
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Kawasaki-shi, Japan
- Rekrutierung
- Sl0044 20365
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Kita-gun, Japan
- Rekrutierung
- Sl0044 20045
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Kitakyushu, Japan
- Rekrutierung
- Sl0044 20065
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Kurashiki, Japan
- Aktiv, nicht rekrutierend
- Sl0044 20301
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Kyoto, Japan
- Rekrutierung
- Sl0044 20369
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Meguro-ku, Japan
- Rekrutierung
- Sl0044 20069
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Nagasaki, Japan
- Rekrutierung
- Sl0044 20071
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Nagoya, Japan
- Rekrutierung
- Sl0044 20287
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Osaka, Japan
- Rekrutierung
- Sl0044 20368
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Saga, Japan
- Rekrutierung
- Sl0044 20084
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Sagamihara, Japan
- Rekrutierung
- Sl0044 20283
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Sapporo, Japan
- Rekrutierung
- Sl0044 20031
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Sasebo, Japan
- Rekrutierung
- Sl0044 20042
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Sendai, Japan
- Aktiv, nicht rekrutierend
- Sl0044 20171
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Shinjuku-ku, Japan
- Rekrutierung
- Sl0044 20288
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Shinjuku-ku, Japan
- Rekrutierung
- Sl0044 20070
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Shinjuku-ku, Japan
- Rekrutierung
- Sl0044 20076
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Shinjuku-ku, Japan
- Rekrutierung
- Sl0044 20285
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Suita, Japan
- Rekrutierung
- Sl0044 20277
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Suita-shi, Japan
- Rekrutierung
- Sl0044 20032
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Toyoake-shi, Japan
- Rekrutierung
- Sl0044 20371
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Tsu, Japan
- Rekrutierung
- Sl0044 20278
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Wakayama, Japan
- Rekrutierung
- Sl0044 20358
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Yokohama, Japan
- Rekrutierung
- Sl0044 20370
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Yoshida-gun, Japan
- Rekrutierung
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Québec, Kanada
- Rekrutierung
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Rimouski, Kanada
- Rekrutierung
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Toronto, Kanada
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Cuernavaca, Mexiko
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Guadalajara, Mexiko
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- Sl0044 50694
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Mexico City, Mexiko
- Rekrutierung
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Amsterdam, Niederlande
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Groningen, Niederlande
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Maastricht, Niederlande
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Arequipa, Peru
- Zurückgezogen
- Sl0044 60026
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San Juan de Lurigancho, Peru
- Rekrutierung
- Sl0044 60008
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Surco, Peru
- Rekrutierung
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Katowice, Polen
- Rekrutierung
- Sl0044 40398
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Katowice, Polen
- Rekrutierung
- Sl0044 40795
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Krakow, Polen
- Rekrutierung
- Sl0044 40502
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Lublin, Polen
- Rekrutierung
- Sl0044 40037
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Poznan, Polen
- Rekrutierung
- Sl0044 40044
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Poznan, Polen
- Rekrutierung
- Sl0044 40821
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Poznan, Polen
- Rekrutierung
- Sl0044 40484
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Warsaw, Polen
- Rekrutierung
- Sl0044 40097
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Warsaw, Polen
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Wroclaw, Polen
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Wroclaw, Polen
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Caguas, Puerto Rico
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San Juan, Puerto Rico
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San Juan, Puerto Rico
- Rekrutierung
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Belgrade, Serbien
- Rekrutierung
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Kragujevac, Serbien
- Rekrutierung
- Sl0044 40466
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Niška Banja, Serbien
- Rekrutierung
- Sl0044 40861
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Novi Sad, Serbien
- Rekrutierung
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A Coruña, Spanien
- Rekrutierung
- Sl0044 40045
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Badajoz, Spanien
- Rekrutierung
- Sl0044 40826
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Barcelona, Spanien
- Rekrutierung
- Sl0044 40160
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Barcelona, Spanien
- Rekrutierung
- Sl0044 40159
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Castellon, Spanien
- Rekrutierung
- Sl0044 40839
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Madrid, Spanien
- Rekrutierung
- Sl0044 40857
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Málaga, Spanien
- Rekrutierung
- Sl0044 40341
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Mérida, Spanien
- Rekrutierung
- Sl0044 40521
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Sabadell, Spanien
- Rekrutierung
- Sl0044 40101
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Santander, Spanien
- Rekrutierung
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Santiago de Compostela, Spanien
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Seville, Spanien
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Seville, Spanien
- Rekrutierung
- Sl0044 40103
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Seville, Spanien
- Rekrutierung
- Sl0044 40106
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Vitoria-Gasteiz, Spanien
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- Sl0044 40863
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Busan, Südkorea
- Rekrutierung
- Sl0044 20141
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Incheon, Südkorea
- Rekrutierung
- Sl0044 20108
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Seoul, Südkorea
- Rekrutierung
- Sl0044 20104
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Seoul, Südkorea
- Rekrutierung
- Sl0044 20351
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Seoul, Südkorea
- Rekrutierung
- Sl0044 20105
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Suwon, Südkorea
- Rekrutierung
- Sl0044 20092
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New Taipei City, Taiwan
- Rekrutierung
- Sl0044 20330
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Taichung, Taiwan
- Rekrutierung
- Sl0044 20080
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Taichung, Taiwan
- Rekrutierung
- Sl0044 20142
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Taichung, Taiwan
- Rekrutierung
- Sl0044 20113
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Taipei, Taiwan
- Rekrutierung
- Sl0044 20086
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Taipei, Taiwan
- Rekrutierung
- Sl0044 20099
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Taipei, Taiwan
- Rekrutierung
- Sl0044 20362
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Taiyuan, Taiwan
- Rekrutierung
- Sl0044 20082
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Dubai, Vereinigte Arabische Emirate
- Rekrutierung
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Arizona
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Avondale, Arizona, Vereinigte Staaten, 85392
- Rekrutierung
- Sl0044 50058
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Chandler, Arizona, Vereinigte Staaten, 85225
- Rekrutierung
- Sl0044 50550
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Gilbert, Arizona, Vereinigte Staaten, 85297
- Rekrutierung
- Sl0044 50713
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Glendale, Arizona, Vereinigte Staaten, 85306
- Rekrutierung
- Sl0044 50662
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Phoenix, Arizona, Vereinigte Staaten, 85032
- Rekrutierung
- Sl0044 50052
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Scottsdale, Arizona, Vereinigte Staaten, 85258
- Rekrutierung
- Sl0044 50677
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Arkansas
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Searcy, Arkansas, Vereinigte Staaten, 72143
- Rekrutierung
- Sl0044 50670
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California
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Beverly Hills, California, Vereinigte Staaten, 90210
- Rekrutierung
- Sl0044 50737
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Beverly Hills, California, Vereinigte Staaten, 90211
- Rekrutierung
- Sl0044 50775
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La Jolla, California, Vereinigte Staaten, 92037
- Rekrutierung
- Sl0044 50257
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La Palma, California, Vereinigte Staaten, 90623-1730
- Rekrutierung
- Sl0044 50275
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Los Alamitos, California, Vereinigte Staaten, 90720
- Rekrutierung
- Sl0044 50755
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Los Angeles, California, Vereinigte Staaten, 90022
- Rekrutierung
- Sl0044 50258
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Menifee, California, Vereinigte Staaten, 92586
- Rekrutierung
- Sl0044 50725
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Orange, California, Vereinigte Staaten, 92868
- Rekrutierung
- Sl0044 50340
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San Leandro, California, Vereinigte Staaten, 94578
- Rekrutierung
- Sl0044 50316
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Rekrutierung
- Sl0044 50719
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Florida
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Brandon, Florida, Vereinigte Staaten, 33511
- Rekrutierung
- Sl0044 50239
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Clearwater, Florida, Vereinigte Staaten, 33765
- Rekrutierung
- Sl0044 50630
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Coral Gables, Florida, Vereinigte Staaten, 33134
- Rekrutierung
- Sl0044 50751
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Gainesville, Florida, Vereinigte Staaten, 32610
- Rekrutierung
- Sl0044 50362
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Hollywood, Florida, Vereinigte Staaten, 33024
- Rekrutierung
- Sl0044 50766
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Margate, Florida, Vereinigte Staaten, 33063
- Rekrutierung
- Sl0044 50763
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Miami, Florida, Vereinigte Staaten, 33172
- Rekrutierung
- Sl0044 50681
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Miami, Florida, Vereinigte Staaten, 33155
- Rekrutierung
- Sl0044 50735
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Miami, Florida, Vereinigte Staaten, 33126
- Rekrutierung
- Sl0044 50747
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Plantation, Florida, Vereinigte Staaten, 33324
- Rekrutierung
- Sl0044 50324
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Tampa, Florida, Vereinigte Staaten, 33618
- Rekrutierung
- Sl0044 50698
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Winter Park, Florida, Vereinigte Staaten, 32789
- Rekrutierung
- Sl0044 50585
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Georgia
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Gainesville, Georgia, Vereinigte Staaten, 30501-2418
- Rekrutierung
- Sl0044 50566
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Marietta, Georgia, Vereinigte Staaten, 30060
- Rekrutierung
- Sl0044 50659
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60616
- Rekrutierung
- Sl0044 50699
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Willowbrook, Illinois, Vereinigte Staaten, 60527
- Rekrutierung
- Sl0044 50717
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Indiana
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New Albany, Indiana, Vereinigte Staaten, 47150
- Rekrutierung
- Sl0044 50748
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242.
- Rekrutierung
- Sl0044 50319
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- Rekrutierung
- Sl0044 50074
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40202-5700
- Rekrutierung
- Sl0044 50586
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70836
- Rekrutierung
- Sl0044 50023
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Lake Charles, Louisiana, Vereinigte Staaten, 70605
- Rekrutierung
- Sl0044 50285
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Rekrutierung
- Sl0044 50660
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Maryland
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Rockville, Maryland, Vereinigte Staaten, 20850
- Rekrutierung
- Sl0044 50730
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48201
- Rekrutierung
- Sl0044 50219
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64151
- Rekrutierung
- Sl0044 50682
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New York
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Brooklyn, New York, Vereinigte Staaten, 11201
- Rekrutierung
- Sl0044 50010
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Manhasset, New York, Vereinigte Staaten, 11030
- Rekrutierung
- Sl0044 50264
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New York, New York, Vereinigte Staaten, 10021
- Rekrutierung
- Sl0044 50077
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Syracuse, New York, Vereinigte Staaten, 13210
- Rekrutierung
- Sl0044 50241
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten, 28211
- Rekrutierung
- Sl0044 50238
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- Rekrutierung
- Sl0044 50262
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- Rekrutierung
- Sl0044 50365
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Tennessee
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Jackson, Tennessee, Vereinigte Staaten, 38305
- Rekrutierung
- Sl0044 50001
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Murfreesboro, Tennessee, Vereinigte Staaten, 37128
- Rekrutierung
- Sl0044 50693
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Texas
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Bellaire, Texas, Vereinigte Staaten, 77401
- Rekrutierung
- Sl0044 50738
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El Paso, Texas, Vereinigte Staaten, 79902
- Rekrutierung
- Sl0044 50781
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Fort Worth, Texas, Vereinigte Staaten, 76109
- Rekrutierung
- Sl0044 50673
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Frisco, Texas, Vereinigte Staaten, 75035
- Rekrutierung
- Sl0044 50562
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Grapevine, Texas, Vereinigte Staaten, 76051
- Rekrutierung
- Sl0044 50773
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Houston, Texas, Vereinigte Staaten, 77090
- Rekrutierung
- Sl0044 50696
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Houston, Texas, Vereinigte Staaten, 77090
- Rekrutierung
- Sl0044 50723
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Houston, Texas, Vereinigte Staaten, 77054
- Abgeschlossen
- Sl0044 50688
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Mansfield, Texas, Vereinigte Staaten, 76063
- Rekrutierung
- Sl0044 50718
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Mesquite, Texas, Vereinigte Staaten, 75150
- Rekrutierung
- Sl0044 50036
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Washington
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Spokane Valley, Washington, Vereinigte Staaten, 99216
- Rekrutierung
- Sl0044 50061
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Bath, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40847
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Belfast, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40858
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Leeds, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40281
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London, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40113
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Newcastle upon Tyne, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40864
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Sheffield, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40701
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West Bromwich, Vereinigtes Königreich
- Rekrutierung
- Sl0044 40725
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
-
Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:
a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 <lower limit of normal (LLN) OR complement C4 <LLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
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Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
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Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
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Historical evidence for anti-dsDNA antibodies
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Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:
- British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND
- SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:
- Antimalarial treatment in combination with glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR
- Treatment with glucocorticoids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)
Exclusion Criteria:
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Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition
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Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy
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Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection [eg, curettage, electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basal cell carcinoma, or dermatological squamous cell carcinoma
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Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
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Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
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Study participant has clinically significant active or latent infection
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Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection
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Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
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Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol
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Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
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Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP
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Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Dapirolizumab pegol
Study participants will receive dapriolizumab pegol throughout the Treatment Period. |
Study participants will receive dapirolizumab pegol (DZP) at prespecified time-points.
Andere Namen:
|
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Placebo-Komparator: Placebo
Study participants will receive placebo throughout the Treatment Period. |
Study participants will receive placebo at prespecified time-points.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48
Zeitfenster: Week 48
|
A study participant is a BICLA responder if all of the following is fulfilled: a. BILAG 2004 improvement without worsening, defined as BILAG 2004 Grade As at Baseline improved to B/C/D, BILAG 2004 Grade Bs at Baseline improved to C/D, and no BILAG 2004 worsening in other BILAG 2004 organ systems (that had BILAG 2004 Grade C/D/E at Baseline) such that there are no new BILAG 2004 Grades A nor greater than 1 new BILAG 2004 Grade(s) B; and b. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI- 2K) total score compared to Baseline (defined as no increase in SLEDAI-2K total score); and c. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline defined as ≤10 mm increase on a 100 mm visual analog scale Escape treatment intervention as indicated by investigator until the assessment time point will be defined as an intercurrent event for the primary endpoint leading to non-response from the day after the event onward. |
Week 48
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Achievement of SRI 4 response at Week 48
Zeitfenster: Week 48
|
The Systemic Lupus Erythematosus Responder Index-4 (SRI 4) define responders as (ie, all criteria must be met):
|
Week 48
|
|
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
Zeitfenster: Week 48
|
Severe BILAG flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A. Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index. |
Week 48
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Achievement of LLDAS at Week 40 and maintaining LLDAS at Weeks 44 and 48
Zeitfenster: Week 40 to Week 48
|
Low lupus disease activity state (LLDAS) is defined as:
|
Week 40 to Week 48
|
|
Change from Baseline to Week 48 in the FATIGUE-PRO Total score
Zeitfenster: From Baseline to Week 48
|
The FATIGUE-PRO (Fatigue patient-reported outcome) is a PRO instrument measuring fatigue, a core symptom of SLE, developed using qualitative and quantitative research conducted in patients with SLE. It is composed of 31 items covering 3 domains: Physical Fatigue (items 1-9), Mental and Cognitive Fatigue (items 10-20), and Susceptibility to Fatigue (items 21-31). The study participant is asked to score each fatigue item based on how frequently they experienced the item during the past 7 days using the following response options: 1=none of the time; 2=a little of the time; 3=some of the time; 4=most of the time; 5=all of the time. |
From Baseline to Week 48
|
|
Percentage of participants having a reduction in glucocorticoid dose from >7.5mg/day prednisone-equivalent dose at Baseline to ≤7.5mg/day at Week 36 and maintained through Week 48
Zeitfenster: From Baseline to Week 48
|
The achievement of a reduction in glucocorticoid dose from >7.5mg/day prednisone equivalent dose at Baseline to ≤7.5mg/day prednisone equivalent at Week 36 and maintained through Week 48 will be assessed. |
From Baseline to Week 48
|
|
Achievement of BILAG 2004 improvement without worsening at Week 48
Zeitfenster: Week 48
|
BILAG 2004 improvement without worsening can be defined as A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B. |
Week 48
|
|
Change from Baseline in PGA at Week 48
Zeitfenster: From Baseline to Week 48
|
Physician's Global Assessment of Disease (PGA), the investigator will rate the overall status of the study participant. The PGA of disease activity used will be a 100 mm linear scale without anchors. The very far left end is 'very good, asymptomatic and no limitation of normal activities'; the very far right end indicates 'severe disease'. |
From Baseline to Week 48
|
|
Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48
Zeitfenster: During Treatment Period up to Week 48
|
A BILAG severe flare is defined as a BILAG 2004 Grade A in any system due to individual items that are new or worse qualifying for the Grade A. Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index. A BILAG moderate flare is defined as 2 or more BILAG 2004 Grade Bs due to individual items that are new or worse since previous visit and are qualifying for the Grade B in any system. Determination of items that are new or worse qualifying for the Grade B will be according to the supplementary information for the numerical scoring of the BILAG-2004 index. |
During Treatment Period up to Week 48
|
|
Change from Baseline in SLEDAI-2K at Week 48
Zeitfenster: From Baseline to Week 48
|
SLEDAI-2K measures disease activity. Disease activity in the 30 days prior to and at the time point of the assessment shall be considered. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The total score falls between 0 and 105, with higher scores representing increased disease activity. |
From Baseline to Week 48
|
|
Change from Baseline in FACIT-Fatigue score at Week 48
Zeitfenster: From Baseline to Week 48
|
The FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue scale is a patient-reported outcome (PRO) measure assessing symptoms and impacts of fatigue originally developed in patients with cancer (Cella et al, 2002). It is composed of 13 items, all scored from 0 (Not at all) to 4 (Very much), and uses a recall period of the past 7 days. The FACIT-Fatigue score ranges from 0 to 52 with 0 being the worst possible score and 52 being the best possible score (lowest level of fatigue). To obtain a score from 0 to 52, all negatively worded questions have to be recoded, so that responses range from worst (0) to the best (4) outcome. |
From Baseline to Week 48
|
|
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Zeitfenster: From Baseline until Safety Follow-Up (up to Week 54)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. |
From Baseline until Safety Follow-Up (up to Week 54)
|
|
Percentage of participants with serious treatment-emergent adverse events during the study
Zeitfenster: From Baseline until Safety Follow-Up (up to Week 54)
|
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
|
From Baseline until Safety Follow-Up (up to Week 54)
|
|
Percentage of participants with treatment-emergent adverse events of special interest during the study
Zeitfenster: From Baseline until Safety Follow-Up (up to Week 54)
|
An adverse event of special interest is any adverse event (AE) that a regulatory authority has mandated be reported on an expedited basis, regardless of the seriousness, expectedness, or relatedness of the AE to the administration of a UCB product/compound. |
From Baseline until Safety Follow-Up (up to Week 54)
|
|
Percentage of participants with treatment-emergent adverse events of special monitoring during the study
Zeitfenster: From Baseline until Safety Follow-Up (up to Week 54)
|
An adverse event of special monitoring is a product-specific adverse event (AE), adverse reaction, or safety topic considered as requiring special monitoring by UCB. |
From Baseline until Safety Follow-Up (up to Week 54)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: UCB Cares, 001 844 599 2273 (UCB)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SL0044
- 2019-003407-35 (EudraCT-Nummer)
- 2023-508191-11 (Registrierungskennung: EU Clinical Trials)
- U1111-1298-3467 (Andere Kennung: World Health Organization (WHO))
- 2023 (US NIH Stipendium/Vertrag)
- 2019 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD-Sharing-Zeitrahmen
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD-Sharing-Zugriffskriterien
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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