Etrasimod for Ulcerative Colitis

(ENDEAVOUR-UC Trial)

Recruiting at 23 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pfizer

Must be taking: Etrasimod

Must not be taking: Methotrexate, Thiopurines, Biologics, others

Disqualifiers: Crohn's disease, Severe colitis, Stoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of etrasimod for adults with moderate to severe ulcerative colitis. Researchers aim to observe changes in patients' symptoms after starting this treatment, which is already part of their standard care. Participants will use a mobile device to complete health questionnaires about their symptoms. The trial is open to those diagnosed with ulcerative colitis who have not previously used etrasimod and for whom their doctor recommends it. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. You cannot take methotrexate, thiopurines, biologics, JAK inhibitors, or other S1P receptor modulators while participating in this trial.

What is the safety track record for etrasimod?

Research has shown that etrasimod has been tested for safety in treating ulcerative colitis. In a large study, 577 participants compared etrasimod to a placebo, a pill with no active medicine. The results indicated that 25% of those taking etrasimod experienced infections, compared to 22% of those taking the placebo.

Long-term studies have also found etrasimod to be generally safe for patients. Most side effects were mild, and patients continued to respond well over time. Overall, etrasimod was well-tolerated in these studies, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Etrasimod is unique because it works by selectively modulating the sphingosine 1-phosphate (S1P) receptor, which is different from the typical approach of using anti-inflammatory drugs or biologics that target immune system pathways more broadly. This targeted mechanism can potentially offer a more precise way to manage moderate to severe ulcerative colitis, possibly reducing inflammation with fewer side effects. Researchers are excited because etrasimod could offer a new option for patients who don't respond well to current treatments like corticosteroids or TNF inhibitors, by providing a novel pathway to control disease symptoms.

What evidence suggests that etrasimod might be an effective treatment for ulcerative colitis?

Research has shown that etrasimod, which participants in this trial will receive, can help treat moderate to severe ulcerative colitis. In one study, 44% of patients experienced almost complete symptom relief after 52 weeks, and 56% reported significant overall improvement. Another study found that 64% of patients had nearly gone symptoms by week 12, though this number dropped to 18% by week 26. Etrasimod helps reduce symptoms like urgency and stomach pain, even when other treatments have failed. These findings suggest that etrasimod can effectively help manage ulcerative colitis symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with UC and prescribed etrasimod.

I have signed a consent form after being informed about the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive etrasimod according to standard of care for 52 weeks

52 weeks

Visits according to standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod

How Is the Trial Designed?

Group I: Adult patients with ulcerative colitis taking etrasimod Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12406896/

Etrasimod for the symptomatic relief of ulcerative colitis Etrasimod demonstrated efficacy in improving urgency, abdominal pain, SF and RB; symptoms improved regardless of biologic/Janus kinase inhibitor ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/Supplement_1/i1537/7968072

P0801 Real-world Effectiveness and Tolerability of Etrasimod ... At week 12, 64% had achieved clinical remission, however this dropped to 18% at week 26 in an intention-to-treat (ITT) analysis (Figure 1B).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2444382425000938

Etrasimod: Review of the efficacy and therapeutic ... At week 52 in the ELEVATE UC 52 study, 44% and 56% of patients treated with etrasimod achieved clinical and symptomatic remission, respectively, compared to 11% ...

4. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)00061-2/fulltext

Etrasimod as induction and maintenance therapy for ... The results of these two phase 3 trials show that once-daily, oral etrasimod 2 mg had clinical efficacy in patients with moderately to severely ...

5. cghjournal.org cghjournal.org/article/S1542-3565(25)00542-7/fulltext

Efficacy of Etrasimod in Ulcerative Colitis: Analysis ... Etrasimod demonstrated significant induction and maintenance efficacy over placebo in both moderate and severe endoscopic disease. Response to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910369/

Etrasimod for the Treatment of Ulcerative Colitis: Up to 2.5 ... Etrasimod for the Treatment of Ulcerative Colitis: Up to 2.5 Years of Pooled Safety Data From Global Clinical Trials. Copyright and License information.

7. velsipity.pfizerpro.com velsipity.pfizerpro.com/safety

Safety Data and Adverse Reactions in ... Overall rates of infections in UC-1: 25% (72/289) for VELSIPITY (etrasimod) vs 22% (32/144) for placebo. Review important safety info including ...

8. nature.com nature.com/articles/s41598-025-19679-z

Safety evaluation of etrasimod for ulcerative colitis based ... This study aims to assess the AEs of etrasimod in UC patients using data from the FDA Adverse Event Reporting System (FAERS) database. By ...

9. velsipity.com velsipity.com/why-velsipity/side-effects-and-safety

Safety & Side Effects: VELSIPITY® (etrasimod) for ... VELSIPITY has demonstrated safety data in clinical trials · The safety of VELSIPITY has been studied in a clinical program with 577 participants across 3 placebo ...

10. academic.oup.com academic.oup.com/ecco-jcc/article/15/6/950/6105062

Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis In this long-term extension study, etrasimod 2 mg demonstrated a favourable safety profile. Most patients with clinical response, clinical ...