NCT05287126 · Pfizer
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
What this study is about
The purpose of this study is to determine the safety, effectiveness, and how the drug moves through the body (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to \< 18 years of age).
View original scientific description
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
DRUG
Etrasimod
Etrasimod tablet or granules by mouth, once daily up to 52 weeks of treatment.
Primary outcome measures
Proportion of Participants Achieving Clinical Remission as Assessed by Modified Mayo Score (MMS) at Week 52
Time frame: Week 52
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Little Rock, Arkansas
- Garden Grove, California
- Loma Linda, California
- San Bernardino, California
- San Francisco, California
- Orlando, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Royal Oak, Michigan
- Cleveland, Ohio
- Abilene, Texas
Collaborators
Arena is a wholly owned subsidiary of Pfizer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations