Etrasimod for Ulcerative Colitis

Recruiting at 65 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

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called etrasimod for teenagers with moderately to severely active ulcerative colitis, a condition that inflames the colon. The goal is to assess the safety and effectiveness of etrasimod and its behavior in the body. Ideal participants have this level of ulcerative colitis and may already use certain UC medications. Conditions like severe extensive colitis or Crohn's disease make a person ineligible for the trial. If the first 52 weeks prove successful, participants can continue the treatment for up to four more years. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain ulcerative colitis medications, so you may not need to stop your current meds. However, it depends on which specific medications you are taking.

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

Studies have shown that etrasimod is generally well-tolerated by people with ulcerative colitis. Research indicates that while some people taking etrasimod experienced side effects, these were mostly mild to moderate. For example, one study found that etrasimod provided significant benefits compared to a placebo and had a favorable balance of benefits to risks, meaning that for most patients, the benefits outweighed the risks. Another study highlighted that etrasimod was effective in treating active ulcerative colitis and was generally safe to use. Overall, existing evidence suggests that etrasimod is safe for treating ulcerative colitis, with side effects that most patients can manage. ^{1 2 3 4 5}

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

Etrasimod is unique because it targets a specific part of the immune system called the sphingosine 1-phosphate receptor. This is different from standard treatments for ulcerative colitis like mesalamine or corticosteroids, which generally work by reducing inflammation more broadly. Researchers are excited about Etrasimod because it offers a potentially more targeted approach, which might lead to fewer side effects and better control of the disease. The specific action on the immune system could mean improved outcomes for patients who haven't responded well to existing therapies.

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

Research has shown that etrasimod can help treat ulcerative colitis. In one study, 64% of patients experienced symptom relief by week 12. Another study found that etrasimod worked well both as an initial treatment and for ongoing management of moderate to severe cases. Patients taking etrasimod improved more than those on a placebo. The treatment consistently proved safe, with no new risks identified. Overall, these studies suggest that etrasimod could be a promising option for managing ulcerative colitis symptoms. ^{4 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 adolescents aged 12 to under 18 with moderately to severely active ulcerative colitis. They can still join if they're on certain other UC treatments, but not if they have Crohn's disease, different types of colitis, or a history of severe extensive colitis.

Inclusion Criteria

My ulcerative colitis is moderate to severe.

I am currently taking medication for ulcerative colitis.

Exclusion Criteria

I have been diagnosed with a specific type of colitis.

I have severe widespread inflammation in my colon.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive etrasimod for the treatment of moderately to severely active ulcerative colitis

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-Term Extension

Participants may continue treatment in a Long-Term Extension period of up to 4 years

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod

Trial Overview The study tests Etrasimod's safety and effectiveness in treating ulcerative colitis over a period of one year, with an option to continue up to five years depending on the drug's approval status in the participant’s country.

How Is the Trial Designed?

Group I: Etrasimod Experimental Treatment 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

Collaborator

Trials

7

Recruited

2,500+

Arena is a wholly owned subsidiary of Pfizer

Industry Sponsor

Trials

11

Recruited

2,600+

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. 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 ...

5. 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.

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. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1420455/full

Efficacy and safety of the S1PR modulator etrasimod in ... This study demonstrates that etrasimod is effective in treating moderately to severely active ulcerative colitis with a favorable benefit-risk profile at week ...