A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

JRCT ID: jRCT2031230586

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 25/05/2024
• Target sample size: 36
• Countries of recruitment: Austria,Japan,Poland,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Etrasimod
Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.
Other Name: APD334

Outcome(s)

Primary Outcome

Primary Outcome Measures:
1.Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Secondary Outcome

Secondary Outcome Measures:
1.Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [ Time Frame: 4 hours (+/- 15 minutes) post-dose ]
2.Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [ Time Frame: pre-dose and 4 hours (+/-15 minutes) post-dose at Day 1; at trough concentrations (approximately 24 hours after the dose taken the day before the study visit) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]
3.Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [ Time Frame: Week 12 ]
4.Proportion of Participants Achieving Endoscopic Improvement at Week 12 [ Time Frame: Week 12 ]
5.Proportion of Participants Achieving Endoscopic Improvement at Week 52 [ Time Frame: Week 52 ]
6.Proportion of Participants Achieving Symptomatic Remission at Week 12 [ Time Frame: Week 12 ]
7.Proportion of Participants Achieving Symptomatic Remission at Week 52 [ Time Frame: Week 52 ]
8.Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for >= 2 weeks Prior to Week 12 [ Time Frame: Week 12 ]
9.Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for >= 12 weeks Prior to Week 52 [ Time Frame: Week 52 ]
10.Proportion of Participants Achieving Clinical Response at Week 12 [ Time Frame: Week 12 ]
11.Proportion of Participants Achieving Clinical Response at Week 52 [ Time Frame: Week 52 ]
12.Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [ Time Frame: Week 12 ]
13.Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ]
14.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [ Time Frame: Week 12 ]
15.Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [ Time Frame: Week 52 ]
16.Number and Severity of Adverse Events [ Time Frame: Up to Week 52 ]
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 17age old
• Gender: Both

Include criteria

Inclusion criteria:
* Have a diagnosis of ulcerative colitis (UC) that is moderately to severely active
* Participants are permitted to be receiving a therapeutic dose of select UC therapies

Exclude criteria

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

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT05287126