Ulcerative Colitis
Conditions
Keywords
Pharmacokinetics, Adolescents, Active Ulcerative Colitis, APD334
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).
Interventions
DRUGEtrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Sponsors
Pfizer
Arena is a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52 | Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
Countries
Japan, Poland, Slovakia, Spain, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed