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Colitis, UlcerativeENDEAVOUR-UCNCT06398626

An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

An observational study of Colitis, Ulcerative, run by Pfizer at 29 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Etrasimod
How many people
300 participants
Where
29 sitesUnited States
Study dates
17 Sep 2024to 7 Jul 2028
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.

Who may be able to join

  • Age ≥ 18 years and < 65 years at baseline
  • Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
  • 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

Who cannot join

  • The presence of clinical findings suggestive of Crohn's disease
  • Severe extensive colitis evidenced by:
  • 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
  • Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
  • Patients with a stoma or planned UC surgical intervention requiring hospitalization
  • Prior/Concomitant Therapy:
Show all 11Show fewer
  • Any previous exposure to etrasimod, including participation in the etrasimod clinical program
  • Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
  • 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
  • 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
  • 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

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

29 sites in 1 country

United States29 sites, 27 recruiting

  • University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology

    Chapel Hill, North Carolina, 27599

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Recruiting

  • OnSite Clinical Solutions, LLC

    Charlotte, North Carolina, 28211

    Recruiting

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

    Recruiting

  • Feinberg School of Medicine Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Recruiting

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

    Recruiting

  • Woodholme Gastroenterology Associates PA

    Glen Burnie, Maryland, 21061

    Recruiting

  • Houston Endoscopy & Research Center

    Houston, Texas, 77079

    Recruiting

  • BI Research Center

    Houston, Texas, 77084

    Recruiting

  • Digestive and Liver Center of Florida Kissimmee

    Kissimmee, Florida, 34741

    Recruiting

  • Scripps Clinic Torrey Pines

    La Jolla, California, 92037

    Recruiting

  • Rocky Mountain Gastroenterology

    Littleton, Colorado, 80120

    Recruiting

  • United Medical Doctors

    Los Alamitos, California, 90720

    Not yet recruiting

  • United Medical Doctors

    Los Alamitos, California, 90720

    Recruiting

  • Gastro Florida

    Lutz, Florida, 33558

    Terminated

  • Gastro Florida

    Lutz, Florida, 33558

    Active, not recruiting

  • Virtua Health

    Marlton, New Jersey, 08053

    Recruiting

  • Reddy GI Associates

    Mesa, Arizona, 85206

    Recruiting

  • WVU Medicine J.W Ruby Memorial Hospital

    Morgantown, West Virginia, 26505

    Recruiting

  • Suburban Gastroenterology Ltd

    Naperville, Illinois, 60540

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Lenox Hill Hospital, Northwell Health

    New York, New York, 10075

    Recruiting

  • Orlando Health/Digestive Health Institute

    Orlando, Florida, 32806

    Not yet recruiting

  • Brooke Army Medical center

    San Antonio, Texas, 78234

    Recruiting

  • Brooke Army Medical center

    San Antonio, Texas, 78234

    Not yet recruiting

  • GI Alliance Research

    Southlake, Texas, 76092

    Recruiting

  • Washington Gastroenterology

    Tacoma, Washington, 98405

    Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, Ohio, 44145

    Recruiting

Other trials in United States

About this study

Official title: A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

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.

Being tested
Etrasimod
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtrasimodDrug

    As provided in real world practice

Study groups in NCT06398626
Study groupRoleWhat they receive
Adult patients with ulcerative colitis taking etrasimodNot described
Receives: Drug: Etrasimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with symptomatic remission

    Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0

    Measured: Week 12

Secondary outcomes (13)

  1. Proportion of patients with symptomatic remission

    Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0

    Measured: Weeks 24, 36, 52

  2. Proportion of patients with symptomatic response

    Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS

    Measured: Weeks 12, 24, 36, 52

  3. Proportion of patients with symptomatic response

    Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS

    Measured: Weeks 12, 24, 36, 52

  4. Proportion of patients with clinical remission

    Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores > 1 point.

    Measured: Weeks 12, 24, 36, 52

  5. Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission)

    Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint

    Measured: Weeks 24, 36, 52

  6. Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission)

    Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint

    Measured: Weeks 24, 36, 52

  7. Change from baseline in fatigue

    Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score

    Normalization of fatigue is defined as a FACIT Fatigue score ≥ 40.1

    Measured: Weeks 12, 24, 36, 52

  8. Change from baseline of bowel urgency

    Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale

    Measured: Weeks 12, 24, 36, 52

  9. Proportion of patients with a clinically meaningful improvement in bowel urgency

    Clinically meaningful improvement in bowel urgency is defined as ≥ 3-point decrease from baseline among patients with baseline bowel urgency score ≥ 3

    Measured: Weeks 12, 24, 36, 52

  10. Proportion of patients in bowel urgency remission

    Bowel urgency remission is defined as a bowel urgency score ≤ 1 among patients with a baseline bowel urgency score ≥ 3 and the overall population

    Measured: Weeks 12, 24, 36, 52

  11. Proportion of patients with complete bowel urgency remission

    Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0

    Measured: Weeks 12, 24, 36, 52

  12. Change from baseline in abdominal pain

    Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale

    Measured: Weeks 12, 24, 36, 52

  13. Proportion of patients with abdominal pain remission

    Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0

    Measured: Weeks 12, 24, 36, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start17 Sep 2024
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion7 Jul 2028 (estimated)

Resources

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
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06398626
Sponsor's protocol ID
C5041047
Other IDs
ENDEAVOUR-UC
Acronym
ENDEAVOUR-UC
Status last verified
Oct 2026
First submitted
30 Apr 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative, run by Pfizer at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. 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?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with symptomatic remission (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06398626.

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 26 Oct 2026.

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