Etrasimod for Ulcerative Colitis

(GLADIATOR UC Trial)

Recruiting at 465 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

234 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether a medication called etrasimod, taken by mouth, is safe and effective for adults with moderately active ulcerative colitis. Ulcerative colitis is a condition where the colon becomes inflamed. Etrasimod works by helping to reduce this inflammation through its effects on the immune system.

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.

What data supports the effectiveness of the drug Etrasimod for treating ulcerative colitis?

Research shows that Etrasimod, a drug that helps control immune responses, increased remission rates in patients with moderately to severely active ulcerative colitis over 12 and 52 weeks, compared to a placebo. It was also found to be generally well tolerated in long-term studies. ^{1 2 3 4 5}

Is Etrasimod safe for humans?

Etrasimod has been tested in several studies for ulcerative colitis and was generally well tolerated, meaning most people did not have serious side effects. However, some studies noted an increase in adverse events (unwanted effects), so it's important to discuss potential risks with your doctor. ^{1 2 3 4 5}

How is the drug etrasimod different from other treatments for ulcerative colitis?

Etrasimod is unique because it is an oral medication that selectively targets specific sphingosine 1-phosphate receptors, which helps prevent immune cells from moving into the bloodstream and causing inflammation. This mechanism offers a new approach compared to other treatments for ulcerative colitis. ^{1 2 3 4 5}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Etrasimod for the treatment of ulcerative colitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

In moderately to severely active UC, etrasimod increased remission at 12 and 52 wk but increased adverse events. [2023]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. [2020]