Etrasimod for Ulcerative Colitis

(ELEVATE UC OLE Trial)

Recruiting at 891 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

778 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \[NCT03945188\] or APD334-302 \[NCT03996369\] or APD334-210 \[NCT04607837\]).

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.

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

Research shows that Etrasimod, an oral medication, helped increase remission in patients with moderate to severe ulcerative colitis over 12 and 52 weeks, as seen in phase 3 studies. Additionally, a phase 2 study demonstrated significant benefits compared to a placebo, indicating its potential as a promising treatment option. ^{1 2 3 4 5}

Is Etrasimod safe for humans?

Etrasimod has been generally well tolerated in clinical trials for ulcerative colitis, with studies showing it was safe for up to 52 weeks, although some participants experienced more adverse events (unwanted side effects) compared to those taking a placebo (a harmless pill used for comparison). ^{1 2 3 4 5}

What makes the drug Etrasimod unique for treating 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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. 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]

2. 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]

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

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

4. England pubmed.ncbi.nlm.nih.gov

Etrasimod for the treatment of ulcerative colitis. [2023]

5. 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]