Actively Recruiting

Age: 0Years +
All Genders
ID07459686

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

Led by Pfizer · Updated on 2026-05-18

553

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess the safety and effectiveness of Velsipity Tablets 2 mg when used long-term, up to 52 weeks, in patients with moderate to severe ulcerative colitis. The study focuses on patients receiving treatment with Velsipity in real-world medical practice. Sponsored by Pfizer, this observational study monitors how the medication performs outside of controlled clinical trials, gathering important safety and symptom remission data. Participants in this study are patients taking Velsipity tablets as prescribed by their doctors. The study observes their treatment over a period of up to one year without assigning any new treatments or placebos. Data collection includes tracking any serious infections, adverse reactions, and symptom improvements during the treatment period. Throughout the study, participants will be monitored for safety outcomes, including the incidence of serious infections and adverse drug reactions, for up to 52 weeks. Researchers will also evaluate the percentage of participants achieving symptomatic remission at 12 weeks and again at 52 weeks. All data will be gathered under actual medical practice conditions, and participants will continue their usual care with their healthcare providers during the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with moderate to severe ulcerative colitis who started treatment with Velsipity for the first time after the study start date
  • Patients who understand the study and consent to sharing their collected information with third parties and for other uses
Not Eligible

You will not qualify if you...

  • Patients who have participated in a clinical study of Velsipity in the past
  • Patients who have previously participated in this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 52 weeks

Participants take Velsipity tablets as prescribed in real world practice.

Visits occur during treatment as per real world practice

Long-term Monitoring

Duration - Up to 52 weeks

Participants are monitored for safety and effectiveness of Velsipity over time.

Visits for safety and symptom monitoring up to 52 weeks

Trial Site Locations

Total: 1 location

1

Pfizer

Tokyo, Japan

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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