Ulcerative Colitis
Etrasimod for Adolescents With Moderately to Severely Active Ulcerative Colitis
This study is investigating the safety, effects, and pharmacokinetics of once-daily oral etrasimod in adolescents ages 12–17 with moderately to severely active ulcerative colitis.
Registry title: A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
20 recruiting U.S. sites ↓Study at a glance
- Age
- 12 Years–17 Years
- Treatment
- Etrasimod
- Design
- Not provided
- Central study contact
- Pfizer CT.gov Call Center1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com
- Sponsor
- Pfizer
Research question
What are the safety, effects, and pharmacokinetics of etrasimod in adolescents with moderately to severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adolescents ages 12 through 17.
- The study is looking for participants diagnosed with ulcerative colitis.
- The ulcerative colitis must be moderately to severely active.
- Participants may be receiving therapeutic doses of certain ulcerative colitis treatments, although the registry does not name them.
Participation overview
What participation may involve
Participants take etrasimod by mouth once daily for up to 52 weeks and undergo assessments of ulcerative colitis activity, drug concentrations, and safety. Those completing 52 weeks may enter a long-term extension lasting up to four additional years. What participation may involve: - Take an etrasimod tablet or granules by mouth once daily. - Complete ulcerative colitis assessments using the modified Mayo Score and Pediatric Ulcerative Colitis Activity Index. - Undergo assessments of endoscopic improvement at Weeks 12 and 52. - Have etrasimod plasma concentrations assessed at specified post-dose and trough timepoints. - Have adverse events, vital signs, and clinical laboratory results monitored through Week 52. The main treatment period lasts up to 52 weeks. Participants who complete it may continue in a long-term extension for up to four years, totaling up to five years after enrollment. The registry reports pharmacokinetic assessment timepoints at Day 1 and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52, but does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- Etrasimod: Participants receive etrasimod as a tablet or granules by mouth once daily for up to 52 weeks.
Study design
How the comparison works
This is an open-label Phase 2 study in which all enrolled participants are assigned to one group receiving etrasimod. The registry lists allocation as not applicable because the study has a single treatment group. The study is open-label, meaning the registry reports no masking. The registry describes only one experimental etrasimod group and no separate comparator group. No placebo arm or placebo intervention is described in the registry record.
Reported activities
Procedures and tests
- Modified Mayo Score assessments evaluate clinical remission and response, including at Weeks 12 and 52.
- Endoscopic improvement is assessed at Weeks 12 and 52.
- The Pediatric Ulcerative Colitis Activity Index is used to assess clinical remission and response at Weeks 12 and 52.
- Plasma etrasimod concentrations are measured at post-dose and trough timepoints.
- Safety monitoring includes adverse events, vital signs, and clinical laboratory results.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have ulcerative colitis that is moderately to severely active.
- Participants may be receiving therapeutic doses of certain ulcerative colitis therapies; the registry does not specify which therapies.
- Participants must be at least 12 years old.
- Participants must be no older than 17 years.
Possible reasons someone may not be able to join
- Adolescents with severe extensive colitis are excluded.
- Adolescents are excluded if they have Crohn's disease, indeterminate colitis, or a current or previous fistula consistent with Crohn's disease.
- Adolescents with microscopic, ischemic, or infectious colitis are excluded.
Important unknowns
What the record does not make clear
- The registry gives several assessment timepoints but does not provide the complete visit schedule, visit length, or whether any visits require overnight stays.
- The registry permits therapeutic doses of select ulcerative colitis therapies but does not identify the permitted drugs or whether doses must remain stable.
- The registry does not report whether any current or previous medicines require a washout period.
- The registry does not describe what rescue treatment is available if ulcerative colitis worsens.
- Endoscopic improvement is assessed at Weeks 12 and 52, but the registry does not describe the endoscopy procedure, preparation, sedation, or whether additional endoscopies are required.
- The registry does not state which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether travel, lodging, meals, or parking are reimbursed.
- The registry does not state whether any visits or assessments can be completed remotely.
- Participants completing 52 weeks may have an opportunity to enter a long-term extension, but the registry does not describe access to etrasimod after the extension ends.
- The study is recruiting overall, but listed locations have different statuses, including recruiting, not yet recruiting, and active but not recruiting.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, and how long does each visit usually take?
- Which current ulcerative colitis medicines can continue, and would any medicine require a washout or dose change?
- What endoscopies are required, and what preparation, anesthesia or sedation, and recovery time are involved?
- What happens if ulcerative colitis worsens during the study, and what rescue treatments are allowed?
- Which study-related costs are covered, and is compensation or travel support available?
- Is the nearest listed site currently enrolling, and can any activities be completed remotely or locally?
- What additional commitments and treatment access are involved in the optional long-term extension?
Before changing care
Questions for your gastroenterologist
- How might the study affect the current ulcerative colitis treatment plan, including medicines that are controlling symptoms?
- How stable is the ulcerative colitis now, and what signs would make trial participation medically concerning?
- What approved treatment alternatives should be considered alongside learning more about this study?
- How should the gastroenterology team and research team coordinate disease monitoring, endoscopies, laboratory testing, and care if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
Study design and administration
- Organization
- Pfizer
- Organization class
- Industry
- Organization study ID
- APD334-207
- Lead sponsor
- Pfizer
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Experimental
Etrasimod
Interventions: Drug: Etrasimod
Interventions
Drug
Etrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Eligibility
12 Years–17 Years
All
Not accepted
Inclusion criteria (2)
- Have a diagnosis of ulcerative colitis (UC) that is moderately to severely activeRegistry-derived · unreviewed
- Participants are permitted to be receiving a therapeutic dose of select UC therapiesRegistry-derived · unreviewed
Exclusion criteria (3)
- Severe extensive colitisRegistry-derived · unreviewed
- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CDRegistry-derived · unreviewed
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitisRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time frame: Week 52
Secondary outcome
Plasma Concentration of Etrasimod at 4 Hours Post-dose (C4h)
Time frame: 4 hours (± 15 minutes) post-dose
Secondary outcome
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
Secondary outcome
Proportion of Participants Achieving Clinical Remission as Assessed by MMS at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving Endoscopic Improvement at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving Endoscopic Improvement at Week 52
Time frame: Week 52
Secondary outcome
Proportion of Participants Achieving Symptomatic Remission at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving Symptomatic Remission at Week 52
Time frame: Week 52
Secondary outcome
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
Secondary outcome
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
Secondary outcome
Proportion of Participants Achieving Clinical Response at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving Clinical Response at Week 52
Time frame: Week 52
Secondary outcome
Proportion of Participants Achieving Clinical Remission by Pediatric Ulcerative Colitis Activity Index (PUCAI) at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving Clinical Remission as Assessed by PUCAI at Week 52
Time frame: Week 52
Secondary outcome
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 12
Time frame: Week 12
Secondary outcome
Proportion of Participants Achieving a Clinical Response as Assessed by PUCAI at Week 52
Time frame: Week 52
Secondary outcome
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.
Recruiting locations in the United States
Arkansas Children's
Not Yet RecruitingLittle Rock, Arkansas, 72202, United States
Arkansas Children's (IP Address)
Not Yet RecruitingLittle Rock, Arkansas, 72202, United States
Valley View Wellness Medical Center
RecruitingGarden Grove, California, 92845, United States
Loma Linda Children's Hospital
Not Yet RecruitingLoma Linda, California, 92354, United States
Loma Linda University Clinical Trial Center
Not Yet RecruitingLoma Linda, California, 92354, United States
Loma Linda University Eye Institute
Not Yet RecruitingLoma Linda, California, 92354, United States
Loma Linda University Medical Center
Not Yet RecruitingLoma Linda, California, 92354, United States
Loma Linda University Pediatric Clinics
Not Yet RecruitingLoma Linda, California, 92354, United States
Loma Linda University Children's Hospital Pediatric Specialty Clinics
Not Yet RecruitingSan Bernardino, California, 92408, United States
University of California San Francisco
RecruitingSan Francisco, California, 94158, United States
University of California San Francisco,
RecruitingSan Francisco, California, 94158, United States
University of California,San Francisco Pediatric ClinicalResearch Center (PCRC)
RecruitingSan Francisco, California, 94158, United States
Arnold Palmer Hospital - Center for Digestive Health and Nutrition
RecruitingOrlando, Florida, 32806, United States
University of Chicago Medical Center
RecruitingChicago, Illinois, 60637, United States
Boston Children's Hospital
RecruitingBoston, Massachusetts, 02115, United States
William Beaumont Hospital/Corewell Health - East
RecruitingRoyal Oak, Michigan, 48073, United States
William Beaumont Hospitals Reference Laboratory
RecruitingRoyal Oak, Michigan, 48073, United States
University Hospitals Cleveland Medical Center
RecruitingCleveland, Ohio, 44106, United States
University Hospitals Cleveland Medical Center Rainbow Babies & Children's Hospital
RecruitingCleveland, Ohio, 44106, United States
ACT-Midwest G1
RecruitingAbilene, Texas, 79606, United States
This study also lists 25 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Mar 18, 2022
- Primary completion
- Jun 16, 2029
- Overall completion
- Jul 10, 2033
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.