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NCT Number: NCT07459686

An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis

A study to assess the safety and effectiveness of Velsipity Tablets 2 mg during long-term treatment (up to a maximum of 52 weeks) in patients with ulcerative colitis under actual medical practice.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • Patients with moderate to severe ulcerative colitis for whom treatment with this drug was started for the first time after the contract date for this study. Patients who have participated in a clinical study of this drug in the past or patients who have participated in this study are excluded.
  • Patients who understand the contents of this study and give consent to provision of the information collected in this study to third parties and the use of it for other purposes.

Treatment and study plan

Velsipity

Drug

2 milligrams(mg) tablet as provided in real world practice

Other names: Etrasimod

Primary outcomes

  1. The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Percentage of Participants With Symptomatic Remission

    Time frame: 12 weeks and 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Velsipity® Tablets 2 mg Special Investigation (Investigation on Long-Term Use in Patients With Ulcerative Colitis)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 10, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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