ELEVATE UC OLE: An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

JRCT ID: jRCT2071200081

Registered date:13/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 12/01/2021
• Target sample size: 131
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Egypt,Japan,Estonia,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Lebanon,Japan,Mexico,Japan,Moldova,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Russian Federation,Japan,Serbia,Japan,Slovakia,Japan,South Africa,Japan
• Study type: Interventional
• Intervention(s): Etrasimod 2 mg tablet by mouth, once daily up to approximately 5 years or until marketing authorization is obtained in the participant's country, whichever comes first

Outcome(s)

• Primary Outcome: The long-term safety profile of etrasimod [ Time Frame: Up to approximately 5 years ]

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 and 3 parent studies including the 40 Week Treatment Study APD334 308 or the Dose Ranging Study APD334 203 and meet the additional criteria:
a. Subjects previously enrolled in Study APD334-203 must have completed the Week 12 visit

b. Subjects previously enrolled in Study APD334-308:
I. Must have completed the Week 52 visit
or
II. Whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1) of Study APD334 302 the subject may be eligible to enroll provided their ES is >= 2 and they meet one of the following entry criteria:
- Rectal bleeding (RB) subscore >= 2 at 2 timepoints at least 7 days and no more than 14 days apart
- RB + stool frequency (SF) subscore >= 4 at 2 timepoints at least 7 days and no more than 14 days apart
- RB subscore >= 2 or RB + SF subscores >= 4 (in any order) at 2 timepoints at least 7 days and no more than 14 days apart

Note: For subjects discontinuing prior to Week 52 of Study APD334 308, an endoscopic evaluation is required to confirm eligibility for the OLE. An endoscopy should be scheduled upon the appearance of UC symptoms but no more than 14 days after the second timepoint for entry criteria above. A proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks.

Exclude criteria

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
Experienced an adverse event that led to discontinuation from one of the parent studies

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT03950232