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RECRUITING

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

NCT06398626 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

Conditions Studied

Interventions

  • DRUG Etrasimod

Study Locations (20)

Florida

  • Gastro Florida — Lutz
  • Orlando Health/Digestive Health Institute — Orlando
  • Best Choice Medical Research Service — Pembroke Pines
  • University of South Florida — Tampa

Texas

  • Houston Endoscopy & Research Center — Houston
  • BI Research Center — Houston
  • Brooke Army Medical center — San Antonio
  • GI Alliance Research — Southlake

California

  • Scripps Clinic Torrey Pines — La Jolla
  • United Medical Doctors — Los Alamitos
  • Amicis Research Center — Valencia

Maryland

  • MGG Group Co., Inc., Chevy Chase Clinical Research — Chevy Chase
  • Woodholme Gastroenterology Associates PA — Glen Burnie

New York

  • NYU Langone Health — New York
  • Lenox Hill Hospital, Northwell Health — New York

Ohio

  • University of Cincinnati College of Medicine — Cincinnati
  • Gastro Intestinal Research Institute of Northern Ohio, LLC — Westlake

Arizona

  • Reddy GI Associates — Mesa

Colorado

  • Rocky Mountain Gastroenterology — Littleton

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2024-09-17
Est. Completion 2028-07-07

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06398626

The ClinicalTrials.gov registry entry for NCT06398626 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 1 intervention — of which Etrasimod is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06398626 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06398626 about?

NCT06398626 is a clinical study titled "An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis". The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice ...

What is the current status of trial NCT06398626?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2024-09-17. Estimated completion is 2028-07-07.

What conditions does trial NCT06398626 study?

This clinical trial studies the following conditions: Colitis, Ulcerative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06398626?

The interventions under investigation include: Etrasimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06398626?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06398626 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial