A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Long-term Efficacy and Safety of ABX464 25 mg or 50 mg Once Daily as a Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors].
This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
All eligible subjects who have completed either one of the induction studies above mentioned, will be given the opportunity to take part in the present ABX464-107 study which consists of 2 treatment phases.
This study consists of a 44-week maintenance treatment phase (Part 1 and Part 2), followed by a 4-year Long Term Extension (LTE) treatment phase and a 28-days follow-up period consisting in the End of Study (EOS) visit.
The maintenance phase is a 44-week double blind, placebo-controlled, phase. Subjects who are clinical responders after 8 weeks induction will be randomized to Part 1, and those who are non-clinical responders will be randomized to Part 2.
At the end of the 44-week maintenance phase, subjects will continue their allocated treatment until the maintenance phase is unblinded.
Once the study is unblinded, all subjects receiving obefazimod will continue their allocated treatment. Subjects receiving placebo will be allocated to obefazimod 25 mg or can terminate the study.
Inclusion Criteria in maintenance phase:
Inclusion criteria in LTE phase:
Exclusion Criteria in maintenance phase:
Exclusion criteria for LTE phase:
Aurora, Colorado 80014, United States
Kansas City, Kansas 66160, United States
Oklahoma City, Oklahoma 73104, United States
Roanoke, Virginia 24014, United States
Caxias do Sul, Rio Grande do Sul 95070-560, Brazil
Botucatu, São Paulo 18618-686, Brazil
North York, Ontario M6A 3B4, Canada
Luoyang, Henan 471003, China
Wuhan, Hubei 430022, China
Wuhan, Hubei 430030, China
Shenyang, Liaoning 110022, China
Hangzhou, Zhejiang 310003, China
Vandœuvre-lès-Nancy, Meurthe Et Moselle 20199 - 54505, France
Heidelberg, Baden-Wurttemberg 69121, Germany
Hyderabad, Andhra Pradesh 500048, India
Hyderabad, Andhra Pradesh 500082, India
Secunderabad, Andhra Pradesh 500003, India
Belagāve, Karnataka 590010, India
New Delhi, National Capital Territory of Delhi 110025, India
Naples, 80131, Italy
Kashiwa-shi, Chiba 277-0871, Japan
Iizuka-shi, Fukuoka 820-8505, Japan
Kurume-shi, Fukuoka 830-0011, Japan
Kurume-shi, Fukuoka 830-8543, Japan
Ota-shi, Gunma 373-8585, Japan
Fukuyama-shi, Hiroshima 720-8520, Japan
Hatsukaichi-shi, Hiroshima 738-8503, Japan
Kure-shi, Hiroshima 737-0023, Japan
Asahikawa-shi, Hokkaido 078-8510, Japan
Kamakura-shi, Kanagawa 247-0056, Japan
Kawasaki-shi, Kanagawa 210-0013, Japan
Nagaoka-shi, Niigata 940-2085, Japan
Okinawa-shi, Okinawa 904-2195, Japan
Fujiidera-shi, Osaka 583-0027, Japan
Ureshino-shi, Saga-ken 843-0393, Japan
Kumagaya-shi, Saitama 360-8567, Japan
Shinjuku-Ku, Tokyo-To 169-0073, Japan
Sumida-ku, Tokyo-To 130-8575, Japan
Sosnowiec, 41-200, Poland
Viana do Castelo, 4904-858, Portugal
Daegu, Gyeongsangbuk-do 42415, South Korea
Ansan-si, North Chungcheong 15355, South Korea
Las Palmas de Gran Canaria, Las Palmas 35019, Spain