Etrasimod for Ulcerative Colitis

Recruiting at 63 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

Trial Summary

What is the purpose of this trial?

This trial is testing etrasimod, a medication aimed at treating severe ulcerative colitis in adolescents aged 12 to 17. The drug works by calming the immune system to reduce inflammation in the colon. Participants will be treated for up to a year, with an option to continue for several more years. Etrasimod is an oral medication designed to help with inflammatory conditions.

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.

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

Research shows that Etrasimod, a drug taken orally, helped more patients with moderate to severe ulcerative colitis achieve remission (a period without symptoms) compared to those who took a placebo (a pill with no active drug) over 12 and 52 weeks. It was generally well tolerated, although some patients experienced more side effects. ^{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}

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

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

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

Treatment Details

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.

Participant Groups

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+

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]