JRCT ID: jRCT2071200080
Registered date:13/01/2021
ELEVATE UC 40 JAPAN: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Japanese Subjects
Basic Information
| Recruitment status | Complete |
|---|---|
| Health condition(s) or Problem(s) studied | Ulcerative colitis |
| Date of first enrollment | 25/12/2020 |
| Target sample size | 35 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | The investigational drug and the placebo are an oral tablet. The investigational drug is APD334 (etrasimod). |
Outcome(s)
| Primary Outcome | Proportion of participants achieving clinical remission |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 16age old |
|---|---|
| Age maximum | <= 80age old |
| Gender | Both |
| Include criteria | Must have completed the Week 12 visit of Study APD334-302 |
| Exclude criteria | 1. If the Investigator considers the subject to be unsuitable for any reason to participate in the study 2. Subjects requiring partial or total colectomy during the APD334-302 study 3. Subjects requiring treatment with prohibited concomitant medications |
Related Information
| Primary Sponsor | IQVIA Services Japan K.K. ICCC: |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | jRCT Inquiry Contact IQVIA Services Japan K.K. |
| Address | 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074 Tokyo Japan 108-0074 |
| Telephone | +81-3-6859-9500 |
| JP_Arena_ELEVATE_UC@iqvia.com | |
| Affiliation | IQVIA Services Japan K.K. |
| Scientific contact | |
| Name | ICCC: IQVIA Services Japan K.K. |
| Address | 4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074 Tokyo Japan 108-0074 |
| Telephone | +81-3-6859-9500 |
| JP_Arena_ELEVATE_UC@iqvia.com | |
| Affiliation | IQVIA Services Japan K.K. |