Etrasimod for Ulcerative Colitis

(GLADIATOR UC Trial)

No longer recruiting at 519 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Arena Pharmaceuticals

Disqualifiers: Severe colitis, Crohn's, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether etrasimod, taken as a pill, can safely and effectively aid individuals with moderately active ulcerative colitis, a condition causing inflammation and sores in the colon. It includes two groups: one taking etrasimod and another taking a placebo, a pill with no active drug. Suitable participants have had ulcerative colitis for at least three months, with symptoms confirmed by a doctor, and experience regular bleeding and inflammation in the colon. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that etrasimod is likely to be safe for humans?

Research has shown that etrasimod is generally well-tolerated by people with ulcerative colitis. One study found that etrasimod provided significant benefits compared to a placebo and was generally safe over a 12-week period. Another study demonstrated that its safety remained consistent even after 52 weeks of use.

In a group of Japanese patients, taking etrasimod daily for up to 12 weeks proved both effective and safe. Most patients did not experience serious side effects. This suggests that etrasimod might be a safe option for people with ulcerative colitis. However, like any medication, some side effects may occur, so discussing potential risks with a doctor is always best. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Etrasimod is unique because it works by modulating the S1P receptor, which is different from the usual immune-suppressing treatments like corticosteroids or biologics used for ulcerative colitis. This mechanism helps reduce inflammation by selectively targeting immune cell trafficking, potentially leading to fewer side effects. Researchers are excited about Etrasimod because it may offer a more precise way to manage ulcerative colitis, improving patient outcomes with potentially fewer complications.

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

Research has shown that etrasimod, which participants in this trial may receive, may help treat moderately active ulcerative colitis. In earlier studies, 64% of patients experienced near disappearance of symptoms by week 12, though this number dropped to 18% by week 26. Another study found that 44% of patients maintained symptom control by week 52. Despite these variations, etrasimod has proven effective and well-tolerated as both an initial and ongoing treatment. Overall, etrasimod appears to help many patients manage their ulcerative colitis symptoms effectively. ^{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?

Adults with moderately active ulcerative colitis, confirmed by recent endoscopy, can join this trial. They should have a history of UC for at least 3 months and not be hospitalized for severe UC recently. People with other types of colitis or Crohn's disease cannot participate.

Inclusion Criteria

Received a surveillance colonoscopy within 12 months before baseline

I was diagnosed with Ulcerative Colitis more than 3 months ago.

My ulcerative colitis is moderately active, with noticeable symptoms and inflammation.

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

I have been diagnosed with Crohn's disease or have a history of fistulas related to it.

I was hospitalized for a severe UC flare-up and received IV steroids within the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either etrasimod or placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod
• Placebo

Trial Overview The study is testing if etrasimod, taken orally, helps adults with moderate ulcerative colitis compared to a placebo (a pill without the drug). Participants won't know which one they're getting as it's chosen randomly.

How Is the Trial Designed?

Group I: Etrasimod 2 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Arena Pharmaceuticals

Lead Sponsor

Trials

29

Recruited

5,800+

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

Arena is a wholly owned subsidiary of Pfizer

Industry Sponsor

Trials

11

Recruited

2,600+

Arena is a wholly owned subsidiary of Pfizer

Collaborator

Trials

7

Recruited

2,500+

Published Research Related to This Trial

In a phase 2 study involving 156 patients with moderately to severely active ulcerative colitis, etrasimod 2 mg demonstrated significant clinical and endoscopic improvements compared to placebo, with a mean improvement in modified Mayo Clinic scores of 0.99 points (P = .009).

Etrasimod 2 mg also resulted in 41.8% of patients achieving endoscopic improvement, compared to only 17.8% in the placebo group (P = .003), while most adverse events were mild to moderate, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Sandborn, WJ., Peyrin-Biroulet, L., Zhang, J., et al.[2020]

Etrasimod was found to be effective as both an induction and maintenance therapy for ulcerative colitis in two phase 3 studies, demonstrating significant improvements in disease activity compared to placebo.

The studies involved a robust design with randomization and double-blinding, ensuring reliable results that support the use of etrasimod as a viable treatment option for patients with ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In moderately to severely active UC, etrasimod increased remission at 12 and 52 wk but increased adverse events. Al-Jabri, R., Afif, W.[2023]

Etrasimod, a once-daily oral medication, significantly improved clinical remission rates in patients with moderately to severely active ulcerative colitis, with 27% achieving remission at 12 weeks compared to 7% in the placebo group in the ELEVATE UC 52 trial.

The treatment was well tolerated, with no reported deaths or malignancies, indicating a favorable safety profile alongside its efficacy in addressing the needs of ulcerative colitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. Sandborn, WJ., Vermeire, S., Peyrin-Biroulet, L., et al.[2023]

Etrasimod is an oral medication that selectively targets S1P receptors (S1PR1, S1PR4, and S1PR5) to prevent lymphocytes from moving into the bloodstream, which is beneficial for treating immune-mediated inflammatory disorders like ulcerative colitis.

In the phase II OASIS study, etrasimod showed promising efficacy and safety for patients with moderate to severe ulcerative colitis, indicating it could be a valuable new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etrasimod for the treatment of ulcerative colitis. Wils, P., Peyrin-Biroulet, L.[2023]

In a long-term study involving 118 patients with moderately-to-severely active ulcerative colitis, etrasimod 2 mg showed a favorable safety profile, with 94% of treatment-emergent adverse events being mild or moderate.

Etrasimod demonstrated significant efficacy, with 64% of patients achieving clinical response and 33% achieving clinical remission by the end of the treatment, and many maintained their improvements from the initial 12-week trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from the Open-label Extension of the OASIS Study. Vermeire, S., Chiorean, M., Panés, J., et al.[2021]

Citations

1. 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).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39989343/

Matching-adjusted indirect comparisons of efficacy ... MAIC results suggest that patients receiving etrasimod have similar induction results but are more likely to have clinical response and clinical remission.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40184206/

A Post Hoc Analysis of Data From the ELEVATE UC ... Regardless of age, a consistent safety profile with no new risks was observed in patients with ulcerative colitis treated with etrasimod 2 mg once daily (QD).

4. 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% ...

5. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(25)00198-0/abstract

Etrasimod as induction and maintenance treatment for ... Etrasimod was effective and well tolerated as an oral induction and maintenance treatment in patients with moderately to severely active ...

6. 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38613425/

Results From the Phase 3 ELEVATE UC Clinical Programme Etrasimod demonstrated significant improvements versus placebo in patients with isolated proctitis, and those with more extensive disease, in most efficacy ...

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

Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis Etrasimod 2 mg provided significant benefit compared with placebo and was generally well tolerated in the OASIS study [NCT02447302], a 12-week ...

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

Etrasimod as induction and maintenance therapy for ... The safety profile up to 52 weeks was consistent with previous studies of etrasimod. Etrasimod is among a new class of small-molecule S1P ...

10. irjournal.org irjournal.org/journal/view.php?number=1117

Efficacy and safety of etrasimod in Japanese patients with ... Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC.