A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis

Sponsor

Arena Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05287126

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whichever comes first.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Etrasimod	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects With Moderately to Severely Active Ulcerative Colitis

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Etrasimod	Drug: Etrasimod Etrasimod tablet by mouth, once daily up to 52 weeks of treatment. Other Names: APD334

Arm

Intervention/Treatment

Experimental: Etrasimod

Drug: Etrasimod

Etrasimod tablet by mouth, once daily up to 52 weeks of treatment.

Other Names:

APD334

Outcome Measures

Primary Outcome Measures

Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 [Week 52]

Secondary Outcome Measures

Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h) [4 hours (± 15 minutes) post-dose]
Plasma Steady State Trough Concentration (Ctrough,ss) of Etrasimod [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]
Steady State Exposure Area Under Plasma Concentration-time Over Dosing Interval (AUCτ) of Etrasimod [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]
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12 [Week 12]
Proportion of Participants Achieving Endoscopic Improvement at Week 12 [Week 12]
Proportion of Participants Achieving Endoscopic Improvement at Week 52 [Week 52]
Proportion of Participants Achieving Symptomatic Remission at Week 12 [Week 12]
Proportion of Participants Achieving Symptomatic Remission at Week 52 [Week 52]
Proportion of Participants with Clinical Remission at Week 12 Who Had Not been Receiving Corticosteroids for ≥ 2 weeks Prior to Week 12 [Week 12]
Proportion of Participants with Clinical Remission at Week 52 Who Had Not been Receiving Corticosteroids for ≥ 12 weeks Prior to Week 52 [Week 52]
Proportion of Participants Achieving Clinical Response at Week 12 [Week 12]
Proportion of Participants Achieving Clinical Response at Week 52 [Week 52]
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12 [Week 12]
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52 [Week 52]
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12 [Week 12]
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52 [Week 52]
Number and Severity of Adverse Events [Up to Week 52]
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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