Clinical trial NCT03915769: To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Ulcerative colitis
Ozanimod
colitis
Ulcerative
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.

Detailed description: Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.

Eligibility criteria: Inclusion Criteria:

Main Inclusion Criteria for Induction and Maintenance Periods

1. Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening.
2. Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report.
3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
4. Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1.

Main Inclusion Criteria for Open-label Extension Period

Subjects must satisfy the following criteria to be enrolled in the study:

1. Must have completed the Week 12 Visit and is non-responder at Week 12
2. Who completes the IP and enters the MP, completes participation through the last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP

Exclusion Criteria:

Main Exclusion Criteria

1. Subject has severe extensive colitis
2. Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis.
3. Subject has positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4. Subject is pregnant or breastfeeding

5. Subject has clinically relevant cardiovascular conditions

Primary outcomes:
measure: Proportion of subjects with clinical response
timeFrame: At Week 12
Secondary outcomes:
measure: Proportion of subjects with clinical remission
timeFrame: At Week 12 and Week 52
measure: Proportion of subjects with a clinical response
timeFrame: At Week 12 and Week 52
measure: Proportion of subjects with endoscopic improvement
timeFrame: At Week 12 and Week 52
measure: Proportion of subjects with mucosal healing
timeFrame: At Week 12 and Week 52
measure: Proportion of subjects with a clinical response
timeFrame: At Week 9
measure: Change in the EuroQol-5 Dimension (EQ-5D) from baseline
timeFrame: At Week 12
measure: Proportion of subject with clinical response
timeFrame: At week 52
measure: Proportion of subjects in remission while off corticosteroids for any length of time
timeFrame: Up to week 52
measure: Adverse Event (AE)
timeFrame: From enrollment until at least 75 days after completion of study treatment
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Local Institution - 104
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Local Institution - 105
state: Hyogo
city: Okayama-shi
country: Japan
facility: Local Institution - 156
state: Okayama
city: Osaka
country: Japan
facility: Local Institution - 132
state: Osaka-shi
city: Osaka-shi
country: Japan
facility: Local Institution - 153
state: Osaka
city: Iruma-gun
country: Japan
facility: Local Institution - 131
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Local Institution - 138
state: Tokyo
city: Abiko
country: Japan
facility: Local Institution - 139
city: Aki-gun
country: Japan
facility: Local Institution - 152
city: Chikushino
country: Japan
facility: Local Institution - 122
city: Fujiidera
country: Japan
facility: Local Institution - 150
city: Fukui
country: Japan
facility: Local Institution - 114
city: Fukui
country: Japan
facility: Local Institution - 124
city: Fukuoka
country: Japan
facility: Local Institution - 161
city: Fukuoka
country: Japan
facility: Local Institution - 164
city: Fukuoka
country: Japan
facility: Local Institution - 155
city: Gifu
country: Japan
facility: Local Institution - 140
city: Hakodate
country: Japan
facility: Local Institution - 151
city: Hirosaki
country: Japan
facility: Local Institution - 133
city: Hiroshima
country: Japan
facility: Local Institution - 160
city: Hiroshima
country: Japan
facility: Local Institution - 106
city: Hitachi, Ibaraki
country: Japan
facility: Local Institution - 126
city: Iizuka
country: Japan
facility: Local Institution - 162
city: Isehara City, Kanagawa
country: Japan
facility: Local Institution - 134
city: Kahoku-gun
country: Japan
facility: Local Institution - 120
city: Kannonji
country: Japan
facility: Local Institution - 135
city: Kashihara
country: Japan
facility: Local Institution - 101
city: Kashiwa
country: Japan
facility: Local Institution - 158
city: Kawagoe
country: Japan
facility: Local Institution - 157
city: Kobe
country: Japan
facility: Local Institution - 163
city: Kobe
country: Japan
facility: Local Institution - 130
city: Komatsu
country: Japan
facility: Local Institution - 121
city: Koriyama
country: Japan
facility: Local Institution - 144
city: Kurume, Fukuoka
country: Japan
facility: Local Institution - 111
city: Kurume
country: Japan
facility: Local Institution - 142
city: Kurume
country: Japan
facility: Local Institution - 165
city: Kyoto-city
country: Japan
facility: Local Institution - 141
city: Matsuyama
country: Japan
facility: Local Institution - 118
city: Minato-ku
country: Japan
facility: Local Institution - 108
city: Minato-ku
country: Japan
facility: Local Institution - 107
city: Mitaka
country: Japan
facility: Local Institution - 109
city: Morioka
country: Japan
facility: Local Institution - 110
city: Nagaoka
country: Japan
facility: Local Institution - 125
city: Nagoya-shi
country: Japan
facility: Local Institution - 167
city: Ogaki
country: Japan
facility: Local Institution - 119
city: Oita
country: Japan
facility: Local Institution - 159
city: Okayama
country: Japan
facility: Local Institution - 136
city: Osaki-shi
country: Japan
facility: Local Institution - 127
city: Otsu
country: Japan
facility: Local Institution - 113
city: Saga
country: Japan
facility: Local Institution - 154
city: Saitama
country: Japan
facility: Local Institution - 116
city: Sakai
country: Japan
facility: Local Institution - 145
city: Sakura
country: Japan
facility: Local Institution - 102
city: Sapporo
country: Japan
facility: Local Institution - 103
city: Sapporo
country: Japan
facility: Local Institution - 147
city: Sendai
country: Japan
facility: Local Institution - 146
city: Shinagawa-ku, Tokyo
country: Japan
facility: Local Institution - 128
city: Shinju-ku
country: Japan
facility: Local Institution - 117
city: Shizuoka-shi
country: Japan
facility: Local Institution - 137
city: Sunto-gun
country: Japan
facility: Local Institution - 149
city: Takamatsu
country: Japan
facility: Local Institution - 112
city: Takatsuki
country: Japan
facility: Local Institution - 115
city: Takatsuki
country: Japan
facility: Local Institution - 143
city: Toshima-ku
country: Japan
facility: Local Institution - 166
city: Toyama
country: Japan
facility: Local Institution - 129
city: Tsu
country: Japan
facility: Local Institution - 123
city: Utsunomiya
country: Japan
facility: Local Institution - 148
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: