NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071210052

Registered date:19/08/2021

Etrasimod Dose-Ranging Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedUlcerative colitis
Date of first enrollment16/10/2021
Target sample size96
Countries of recruitment
Study typeInterventional
Intervention(s)Eligible subjects will be randomized (1:1:1ratio) to receive either etrasimod (dose A), etrasimod (dose B), or matching placebo (once daily) in a double-blind fashion for 12 weeks

Outcome(s)

Primary OutcomeThe proportion of subjects achieving clinical remission at Week 12
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria- Japanese ancestry - Diagnosed with ulcerative colitis (UC) => 3 months prior to screening - Having active UC confirmed by endoscopy - Moderately to severely active UC
Exclude 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

Related Information

Contact

Public contact
Name jRCT Call Center IQVIA Services Japan K.K.
Address 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074 Tokyo Japan 108-0074
Telephone +81-120-229-053
E-mail JP_Arena_ELEVATE_UC@iqvia.com
Affiliation IQVIA Services Japan K.K.
Scientific contact
Name Masakazu Tanabe
Address 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074 Tokyo Japan 108-0074
Telephone +81-80-9778-3708
E-mail JP_Arena_ELEVATE_UC@iqvia.com
Affiliation IQVIA Services Japan K.K.