What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as immunosuppressants (e.g., azathioprine, 6-mercaptopurine), biologics (e.g., infliximab, adalimumab), and corticosteroids, have a range of side effects. Immunosuppressants can cause infections, liver toxicity, and bone marrow suppression. Biologics may lead to infusion reactions, increased risk of infections, and potential development of antibodies against the drug. Corticosteroids are associated with weight gain, glucose intolerance, osteoporosis, and increased susceptibility to infections. These side effects highlight the need for careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

The FDA has approved several treatments for Crohn's Disease, primarily focusing on biologics and immunosuppressants. These include anti-TNF agents like infliximab, adalimumab, and certolizumab pegol, which target tumor necrosis factor-alpha to reduce inflammation. Other approved treatments include integrin receptor antagonists like vedolizumab and interleukin inhibitors such as ustekinumab. While Etrasimod, a Selective Sphingosine 1-Phosphate (S1P) Receptor Modulator, is still under investigation, it represents a novel approach compared to the existing biologics and immunosuppressants.

What other types of research exist?

Promising novel alternatives to Etrasimod for Crohn's Disease patients include selective sphingosine kinase inhibitors like ABC294640, which has shown efficacy in reducing inflammation in rodent models of arthritis, and TNF-alpha inhibitors such as infliximab, adalimumab, golimumab, and certolizumab pegol, which are well-established in treating IBD. Additionally, mTOR inhibitors like sirolimus and temsirolimus, which have shown potential in other inflammatory conditions, may also be considered.

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Sphingosine 1-phosphate receptor modulator

Oral Etrasimod for Crohn's Disease (CULTIVATE Trial)

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women 18 to 80 years of age

Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments

Must not have

Have an ileostomy or a colostomy

Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new oral medication called etrasimod for adults with severe Crohn's disease who haven't had success with other treatments. The medication aims to reduce gut inflammation by calming the immune system. The study will last several years and includes different stages to determine the best dosage and long-term effects. Etrasimod is also being tested for ulcerative colitis and may avoid issues that can lead to treatment failure with other therapies.

Who is the study for?

Adults aged 18-80 with moderate to severe Crohn's Disease, who haven't responded well to or can't tolerate steroids, immunosuppressants, or biologics. They must be able to follow the study plan and use contraception if they can have children.

What is being tested?

The trial is testing Etrasimod, an oral medication for Crohn's Disease. It compares Etrasimod against a placebo over several years to check its effectiveness and safety in those not helped by standard treatments.

What are the potential side effects?

Possible side effects of Etrasimod include headache, nausea, respiratory infections, high blood pressure, and potential impacts on liver function. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have been diagnosed with Crohn's disease for at least 3 months.

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My Crohn's disease is currently moderate to severe.

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I have Crohn's disease and treatments like steroids, immunosuppressants, or biologics didn’t work for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You have a surgical opening in your abdomen to help eliminate waste.

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I have short-bowel syndrome that might need surgery or affect treatment results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 70 weeks for substudy a,approximately 24 weeks for substudy 1 and 2; 42 weeks for substudy 3; and 212 weeks for substudy 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants With Clinical Remission CDAI [Substudy 3]

Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]

Proportion of Participants With Endoscopic Response [Substudy 1]

+3 more

Secondary study objectives

Change From Baseline in CDAI Score [Substudy A]

Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]

Change from baseline in CD-PRO/SS [Substudy 2]

+16 more

Side effects data

From 2022 Phase 3 trial • 42 Patients • NCT04706793

14%

Headache

11%

Malaise

11%

Pyrexia

Colitis ulcerative

Vaccination site pain

Back pain

COVID-19

Contusion

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Comparator: Placebo

Experimental: Etrasimod 2 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Etrasimod Dose BExperimental Treatment1 Intervention

Group II: Etrasimod Dose AExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Etrasimod

2020

Completed Phase 3

~1580

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Crohn's Disease include corticosteroids, immunosuppressants, biologics, and newer agents like Etrasimod. Corticosteroids reduce inflammation by suppressing the immune response, providing rapid relief of symptoms. Immunosuppressants such as thiopurines and methotrexate inhibit the proliferation of immune cells, helping to maintain remission. Biologics, including anti-TNF agents, target specific molecules involved in the inflammatory process, offering targeted therapy for moderate to severe cases. Etrasimod, a selective sphingosine 1-phosphate (S1P) receptor modulator, works by preventing lymphocytes from migrating to the gut, thereby reducing inflammation. Understanding these mechanisms is crucial for Crohn's Disease patients as it helps tailor treatment plans to effectively manage symptoms and maintain long-term remission.

Fostering Inflammatory Bowel Disease: Sphingolipid Strategies to Join Forces.