Ulcerative Colitis (UC)NCT07459686
An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Velsipity
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteJapan
- Study dates
- 27 Apr 2026to 29 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VELSIPITY® TABLETS 2 MG SPECIAL INVESTIGATION (INVESTIGATION ON 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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Velsipity
- Keywords
- Etrasimod, Velsipity, Ulcerative Colitis, UC
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelsipityDrug
Also called Etrasimod
2 milligrams(mg) tablet as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with ulcerative colitis | Patients taking velsipity Receives: Drug: Velsipity |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)
Measured: Up to 52 weeks
Secondary outcomes (1)
Percentage of Participants With Symptomatic Remission
Measured: 12 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start27 Apr 2026
- Primary completion29 Jan 2029 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459686
- Sponsor's protocol ID
- C5041036
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VELSIPITY® TABLETS 2 MG SPECIAL INVESTIGATION (INVESTIGATION ON LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
- ClinicalTrials.gov ID
- NCT07459686
- Acronym / sponsor ID
- C5041036
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Etrasimod, Velsipity, Ulcerative Colitis, UC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 29 Jan 2029 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ulcerative colitis | – | Drug: VelsipityPatients taking velsipity |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VelsipityAlso: Etrasimod2 milligrams(mg) tablet as provided in real world practice | Drug | Patients with ulcerative colitis |
Primary outcome
The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)
Time frame: Up to 52 weeks
1 secondary outcome
Percentage of Participants With Symptomatic Remission
Time frame: 12 weeks and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Ulcerative Colitis (UC)
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Colitis, Ulcerative
Active, not recruitingPhase 4
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Ulcerative Colitis
Recruiting
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions) (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.