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Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

NCT05061446

CompletedPhase 2

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: Etrasimod, Etrasimod, Placebo

Countries: Japan

The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Japanese ancestry
* Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
* Having active UC confirmed by endoscopy
* Moderately to severely active UC

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Locations (80)

Nagakute, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Toyohashi, Aichi-ken, Japan
Nagoya, Aixhi-ken, Japan
Hirosaki-shi, Aomori, Japan
Hirosaki-shi, Aomori, Japan
Hirosaki-shi, Aomori, Japan
Kashiwa-shi, Chiba, Japan
Nagareyama-shi, Chiba, Japan
Sakura, Chiba, Japan
Matsuyama, Ehime, Japan
Toon-shi, Ehime, Japan
Fukuoka, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Kurume, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Kutakyushu-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Gifu, Gifu, Japan
Ota-shi, Gunma, Japan
Fukuyama-shi, Hiroshima, Japan
Fukuyama-shi, Hiroshima, Japan
Hiroshima, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
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