51
Participants
Start Date
July 26, 2019
Primary Completion Date
January 24, 2022
Study Completion Date
July 12, 2022
Ustekinumab 6 mg/kg
Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
Ustekinumab 90 mg
Participants will receive ustekinumab 90 mg SC at Week 8 and every 8 Weeks (q8w) through Week 72 in Group 1 and q8w Week 32 through Week 72 in Group 2.
Placebo IV
Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Placebo SC
Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
Tokyo Medical and Dental University Hospital, Bunkyō City
Fukushima Medical University Hospital, Fukushima
Shinko Hospital, Hyōgo
Tokai University Hospital, Isehara
Kagoshima University Hospital, Kagoshima
St Marianna University Hospital, Kanagawa
National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano
Hospital of the University of Occupational and Enviromental Health, Kitakyushu
Kumamoto University Hospital, Kumamoto
Kurashiki Central Hospital, Kurashiki
Shinshu University Hospital, Matsumoto
Minaminagano Medical Center Shinonoi General Hospital, Nagano
Nagasaki University Hospital, Nagasaki
National Hospital Organization Nagoya Medical Center, Nagoya
Niigata University Medical And Dental Hospital, Niigata
Okayama City General Medical Center Okayama City Hospital, Okayama
Saga University Hospital, Saga
Kitasato University Hospital, Sagamihara
Sakai City Medical Center, Sakai
Tohoku University Hospital, Sendai
Tohoku Medical And Pharmaceutical University Hospital, Sendai
Dokkyo Medical University Hospital, Shimotsuga Gun
Center Hospital of the National Center for Global Health and Medicine, Shinjuku Ku
The Jikei University Hospital, Tokyo
Nippon Medical School Hospital, Tokyo
Juntendo University Hospital, Tokyo
Tokyo Medical University Hospital, Tokyo
Fujita Health University Hospital, Toyoake
Ehime University Hospital, Tōon
University of Tsukuba Hospital, Tsukuba
Yamaguchi University Hospital, Ube
Yokohama Rosai Hospital, Yokohama
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY