NCT06398626 An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
| NCT ID | NCT06398626 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | Colitis, Ulcerative |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-09-17 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years and \< 65 years at baseline 2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC 3. Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study Exclusion Criteria: 1. The presence of clinical findings suggestive of Crohn's disease 2. Severe extensive colitis evidenced by: 1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks 2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization 4. Prior/Concomitant Therapy: 1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program 2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine) 3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator 5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool 6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06398626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Colitis, Ulcerative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398626 currently recruiting?
Yes, NCT06398626 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06398626 trial being conducted?
This trial is being conducted at Mesa, United States, La Jolla, United States, Los Alamitos, United States, Los Alamitos, United States and 11 additional locations.
Who is sponsoring the NCT06398626 clinical trial?
NCT06398626 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 300 participants.