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Active, not recruitingNCT07459686Updated Sep 4, 2026

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

An observational study in Ulcerative Colitis (UC), sponsored by Pfizer. Active, not recruiting at 1 site in Japan. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
0 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ulcerative Colitis (UC)

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Keywords

  • Etrasimod, Velsipity, Ulcerative Colitis, UC
03

In context

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's enrollment of 1 is below the median of 157 across 395 observational studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

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

  1. 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.
  2. 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • Patients with ulcerative colitis

    Patients taking velsipity

    Drug: Velsipity

Interventions

  • DrugVelsipity

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

    Also known as: Etrasimod

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What researchers measure

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

07

Study locations

1 site
  • Pfizer
    Tokyo, Japan
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References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07459686
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Apr 27, 2026
Primary completion
Jan 29, 2029 (estimated)
Completion
Jan 29, 2029 (estimated)
Last update
Sep 4, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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