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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCT2071210052 |
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Date of registration:
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19/08/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Etrasimod Dose-Ranging Versus Placebo as Induction Therapy in
Moderately to Severely Active Ulcerative Colitis
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Scientific title:
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week
Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in
Japanese Subjects with Moderately to Severely Active Ulcerative Colitis |
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Date of first enrolment:
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16/10/2021 |
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Target sample size:
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96 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT2071210052 |
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Study type:
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Interventional |
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Study design:
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randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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jRCT Call Center
IQVIA Services Japan K.K. |
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Address:
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4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074
108-0074
Tokyo
Japan |
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Telephone:
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+81-120-229-053 |
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Email:
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JP_Arena_ELEVATE_UC@iqvia.com |
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Affiliation:
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IQVIA Services Japan K.K. |
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Name:
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Masakazu
Tanabe |
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Address:
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4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074
108-0074
Tokyo
Japan |
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Telephone:
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+81-80-9778-3708 |
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Email:
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JP_Arena_ELEVATE_UC@iqvia.com |
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Affiliation:
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IQVIA Services Japan K.K. |
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Key inclusion & exclusion criteria
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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
Age minimum:
>= 20age old
Age maximum:
<= 80age old
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
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Intervention(s)
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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
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Primary Outcome(s)
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The proportion of subjects achieving clinical remission at Week 12
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date:
Contact:
kawakubo-mitsuaki@kyusyu.jcho.go.jp
JCHO Kyushu Hospital Institutional Review Board
+81-93-641-5111
kawakubo-mitsuaki@kyusyu.jcho.go.jp
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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