Etrasimod + Corticosteroids for Colitis

Overseen By Harriet Kluger, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Corticosteroids

Must not be taking: Anti-TNFα, Mycophenolate

Disqualifiers: Severe hepatic impairment, Diabetes, Cardiovascular, Infections, others

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

Compensation: Varies

Number of Visits: 3

Duration: 17 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining etrasimod, a potential new drug, with corticosteroids is more effective than corticosteroids alone in treating colitis caused by certain cancer treatments. The study focuses on patients with advanced cancer who develop colitis from immunotherapy drugs, which can lead to diarrhea and colitis symptoms. Ideal candidates for this trial are those experiencing significant colitis symptoms while undergoing immunotherapy for cancer. Participants will receive either etrasimod plus corticosteroids or a placebo (a substance with no active drug) plus corticosteroids for up to 120 days. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that you cannot continue using certain drugs listed in Appendix 4 of the protocol. It is best to discuss your current medications with the study team to determine if any need to be stopped.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that etrasimod is generally safe and effective as a treatment. In people with ulcerative colitis, studies have found it to be both effective and safe, with many patients experiencing improvement without serious side effects. One study found that etrasimod rarely causes severe problems, indicating a good safety record. These findings support its potential use with corticosteroids.

The current trial examines how etrasimod works with corticosteroids to treat colitis caused by certain cancer treatments. This combination aims to reduce the side effects of cancer treatments while maintaining their effectiveness. So far, evidence suggests that etrasimod is a safe option for patients needing additional help for colitis. ^{1 2 3 4 5}

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

Researchers are excited about etrasimod for colitis because it offers a new approach by targeting the S1P (sphingosine 1-phosphate) receptor, which helps regulate immune cell movement and reduce inflammation. Unlike traditional treatments that mainly focus on broad immune suppression, etrasimod specifically modulates immune cell traffic, potentially leading to fewer side effects. Additionally, when combined with corticosteroids, it may enhance the treatment's effectiveness and speed up symptom relief, providing a promising alternative for patients with this challenging condition.

What evidence suggests that etrasimod plus corticosteroids could be an effective treatment for colitis?

In this trial, participants will receive either Etrasimod plus corticosteroids or a placebo plus corticosteroids. Studies have shown that Etrasimod can help treat conditions like ulcerative colitis. In earlier research, 44% to 56% of patients experienced symptom relief and achieved remission by week 52, compared to only 11% who took a placebo. Another study found that about 65% of patients showed improvements in their gut lining, indicating a healthier appearance. Etrasimod adjusts the immune system, which might help manage colitis caused by medications that boost the immune system to fight cancer. These findings suggest that Etrasimod could effectively reduce inflammation and symptoms in colitis patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Harriet Kluger, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for patients with grade ≥2 diarrhea and colitis caused by immune checkpoint inhibitors, used alone or with other treatments. Participants must need corticosteroid treatment but not immediate intense immunosuppression.

Inclusion Criteria

My cancer cannot be removed by surgery and has spread.

I need steroids for severe diarrhea and colitis.

I am willing and able to follow the study's medication and requirements.

Exclusion Criteria

I have a confirmed gut infection from a stool test.

Active psychiatric problems that could interfere with compliance with the study procedures

I have had serious infections or widespread herpes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive Etrasimod or placebo plus corticosteroids for up to 120 days

17 weeks

Multiple visits (in-person) for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Etrasimod

Trial Overview The study tests if etrasimod plus corticosteroids can better manage Immune Checkpoint Inhibitor Diarrhea and Colitis than a placebo plus corticosteroids, potentially reducing the total steroids needed.

How Is the Trial Designed?

Group I: Etrasimod plus corticosteroids Experimental Treatment 2 Interventions

Participants will receive Etrasimod plus corticosteroids, to be given up to 120 days, to treat IMDC.

Group II: Placebo plus corticosteroids Placebo Group 2 Interventions

Participants will receive Placebo plus corticosteroids, to be given up to 120 days, to treat IMDC.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Pfizer

Industry 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

Published Research Related to This Trial

Corticosteroids are the primary treatment for acute ulcerative colitis, but in cases where the disease does not respond, immunosuppressive therapies like azathioprine and cyclosporin may be necessary.

While these treatments can be effective, their potential side effects and the risk of long-term complications, such as cancer in patients with chronic extensive colitis, must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of corticosteroids and immunosuppressive agents in ulcerative colitis. Connell, WR., Taylor, AC.[2019]

In a study involving 146 patients with active distal ulcerative colitis, budesonide enemas (2 mg/100 ml) showed similar efficacy to prednisolone enemas (25 mg/100 ml) in improving clinical symptoms and proctoscopy findings after 2 weeks of treatment.

Budesonide enemas did not significantly affect plasma cortisol levels, indicating a potentially safer profile compared to prednisolone, which reduced cortisol by about 30%, suggesting less impact on the hypothalamic-pituitary-adrenal axis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide enema in distal ulcerative colitis. A randomized dose-response trial with prednisolone enema as positive control. The Danish Budesonide Study Group. [2019]

Immunosuppressant and biologic therapies for Crohn's disease and ulcerative colitis can lead to a range of adverse events, from mild symptoms to serious complications like infections and cancers, highlighting the importance of careful monitoring.

The review emphasizes the need for healthcare providers to engage in personalized risk-benefit discussions with patients regarding these therapies, considering individual risk factors to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in IBD therapy: the 2018 update. Quezada, SM., McLean, LP., Cross, RK.[2019]

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/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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2444382425000938

Etrasimod: Review of the efficacy and therapeutic ... At week 52 in the ELEVATE UC 52 study, 44% and 56% of patients treated with etrasimod achieved clinical and symptomatic remission, respectively, compared to 11% ...

4. cghjournal.org cghjournal.org/article/S1542-3565(25)00542-7/fulltext

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

5. journals.lww.com journals.lww.com/10.14309/01.ajg.0001134208.06192.17

S1687 Long-Term Efficacy of Etrasimod in Patients With... Endoscopic improvement was observed in ∼65% of pts at both timepoints (Wk 52: 53.2%; Wk 104: 43.9%). Symptomatic response and symptomatic remission were ...

6. nature.com nature.com/articles/s41598-025-19679-z

Safety evaluation of etrasimod for ulcerative colitis based ... This study collected 1406 AE reports from the FAERS database between 2004 and 2024, in which etrasimod was identified as the PS for the AEs. We ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455601/

A Post Hoc Analysis of Data From the ELEVATE UC Clinical ... Here, we evaluate the impact of age on etrasimod safety and efficacy in patients with UC in the phase 3 ELEVATE UC clinical program. Methods.

8. 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 ...

9. academic.oup.com academic.oup.com/ibdjournal/article/31/10/2681/8046180

Efficacy and Safety of Etrasimod in Patients With Moderately to ... In the ELEVATE UC clinical program, etrasimod treatment of patients with moderately to severely active ulcerative colitis led to greater disease ...

10. journals.lww.com journals.lww.com/ajg/fulltext/2025/10002/s1904_efficacy_and_safety_of_etrasimod_for.1905.aspx

S1904 Efficacy and Safety of Etrasimod for Moderate to... Etrasimod demonstrates consistent efficacy across multiple remission endpoints and maintains a favorable safety profile. These findings highlight its potential ...