Etrasimod for Ulcerative Colitis

(ELEVATE UC OLE Trial)

Not currently recruiting at 1074 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: Unsuitable by investigator, Adverse event, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of etrasimod for individuals with moderately to severely active ulcerative colitis (UC). It focuses on those who participated in specific studies and still experience active UC. If previous study participation did not improve or worsened your UC, this trial might suit you. Participants should not have experienced serious side effects that led to leaving the earlier study. As a Phase 3 trial, this is the final step before FDA approval, offering a chance to contribute to a treatment nearing potential availability.

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 team or your doctor.

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

Research has shown that etrasimod, a treatment for ulcerative colitis, is generally well-tolerated by patients. One study compared etrasimod to a placebo and found significant benefits, with the treatment being well-tolerated over a 12-week period.

A review of safety data from the FDA Adverse Event Reporting System supports these findings. The data indicated that while some patients experienced side effects, they were not severe for most.

Another study tested etrasimod in both short-term and long-term settings, finding it effective and safe for many patients with ulcerative colitis, with no major side effects for most.

Overall, the safety evidence is positive, and the treatment has been tested in several studies with many participants. ^{1 2 3 4 5}

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

Etrasimod is unique because it works differently from most current treatments for ulcerative colitis, like mesalamine or biologics such as infliximab. It targets the S1P receptor, which plays a key role in regulating immune cell movement, potentially reducing inflammation more precisely. This novel mechanism of action could mean fewer side effects and a more targeted approach to managing the condition, making researchers hopeful about its potential benefits for patients.

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

Research has shown that etrasimod can help treat ulcerative colitis (UC). In one study, people with moderate to severe UC who took etrasimod improved more than those who took a placebo. Another study found that patients on etrasimod were more likely to see their symptoms improve and even disappear. Specifically, 64% of patients were symptom-free after 12 weeks, but this number dropped to 18% by week 26 in real-life situations. Overall, etrasimod is considered effective and well-tolerated for initiating and maintaining treatment in people with moderately to severely active UC. ^{5 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis who were in previous phase 2 or 3 trials of etrasimod. They must have finished at least 12 weeks of the prior study and still have active symptoms, or their condition must not have improved or worsened.

Inclusion Criteria

People who were previously enrolled in the study called APD334-302 must have finished their visit at Week 12.

I was in a previous study and either my UC didn't improve by Week 12 or I completed Week 52.

Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies and meet the following additional criteria:

Exclusion Criteria

Experienced an adverse event that led to discontinuation from parent study

If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive etrasimod 2 mg per day to evaluate safety and efficacy in moderately to severely active ulcerative colitis

Up to approximately 8 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod

Trial Overview The trial tests the long-term safety and effectiveness of etrasimod, a medication for ulcerative colitis. Participants will receive etrasimod openly, meaning they'll know they're getting the actual drug, not a placebo.

How Is the Trial Designed?

Group I: Etrasimod 2 mg 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

Arena Pharmaceuticals

Lead Sponsor

Trials

29

Recruited

5,800+

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

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]

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]

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]

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/S1542356525005427

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

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40222016/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... ... etrasimod ELEVATE UC clinical program (UC trial-similar), (4) individuals without UC (Non-UC). Data were extracted (1/2016-12/2022) from the ...