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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 (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)

A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis (A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis)

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

May. 25, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Ulcerative Colitis

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

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 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.

+81-45-722-8655

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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