What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as anti-TNF antibodies, Janus kinase inhibitors, and immunomodulators like azathioprine and 6-mercaptopurine, have various side effects. Anti-TNF antibodies can cause adverse events like infections, infusion reactions, and loss of drug efficacy over time. Janus kinase inhibitors may lead to increased risk of infections, elevated liver enzymes, and blood clots. Immunomodulators such as azathioprine and 6-mercaptopurine are associated with bone marrow suppression, hepatotoxicity, increased susceptibility to infections, and potential gastrointestinal disturbances. Ozanimod, a Sphingosine 1-Phosphate Receptor Modulator, shares some similar risks, including infections and liver injury.

What prior FDA approvals exist?

The FDA has approved several treatments for Crohn's Disease, including biologic agents and immunomodulators. Notably, anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol have been widely used. Vedolizumab, an integrin receptor antagonist, is another biologic approved for this condition. While Ozanimod, a Sphingosine 1-Phosphate Receptor Modulator, is being studied for Crohn's Disease, similar drugs like fingolimod and siponimod have been approved for multiple sclerosis, indicating a potential for crossover in therapeutic applications.

What other types of research exist?

Promising novel alternatives to Ozanimod for Crohn's Disease patients include: 1) AZD9056, a selective inhibitor of the purinergic receptor P2X7, which has shown efficacy and safety in a phase IIa study. 2) Anti-TNF therapies, such as thalidomide and CNI-1493, which have shown preliminary positive results in pilot studies. These alternatives offer new mechanisms of action and potential benefits for patients with moderately to severely active Crohn's Disease.

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Sphingosine 1-phosphate receptor modulator

Oral Ozanimod for Crohn's Disease

Phase 3

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450

Crohn's disease for ≥ 3 months on endoscopy and on histological exam

Must not have

Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention

Current stoma, ileal-anal pouch anastomosis, or fistula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a pill called ozanimod to see if it can help people with moderate to severe Crohn's Disease. The medication aims to reduce gut inflammation by stopping certain immune cells from causing damage. Ozanimod is already approved for treating another similar condition and is now being tested for Crohn's disease.

Who is the study for?

This trial is for people with moderate to severe Crohn's Disease who haven't had success with steroids, immunomodulators, or biologics. They should have a certain level of disease activity and inflammation in the intestines. It's not for those with a stoma, extensive bowel surgery, or other types of colitis.

What is being tested?

The study tests oral ozanimod as an initial treatment against a placebo to see how effective it is in reducing symptoms of Crohn's Disease. Participants will be randomly assigned to receive either the medication or placebo.

What are the potential side effects?

Ozanimod may cause side effects like headaches, high blood pressure, liver enzyme elevations, and respiratory infections. There might also be potential risks related to immune system changes since ozanimod affects immune response.

Eligibility Criteria

Inclusion Criteria

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

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My Crohn's disease is active but not extremely severe.

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

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I experience frequent bowel movements or significant abdominal pain daily.

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My condition didn't improve with steroids, immune treatments, or biologics.

Exclusion Criteria

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

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I have been diagnosed with a type of colitis or have strictures needing treatment.

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I have a stoma, ileal-anal pouch, or fistula.

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I have had a major part of my small intestine removed or I need nutrition through an IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734

49%

Influenza Like Illness

12%

Headache

11%

Nasopharyngitis

Upper Respiratory Tract Infection

Orthostatic Hypotension

Pyrexia

Alanine Aminotransferase Increased

Urinary Tract Infection

Hypertension

Pharyngitis

Gamma-Glutamyltransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Interferon Beta-1a

Ozanimod 0.5 mg

Ozanimod 1 mg

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Administration of oral OzanimodExperimental Treatment1 Intervention

Subjects will receive ozanimod 0.92 mg capsule orally starting with a 7-day dose escalation

Group II: Administration of PlaceboPlacebo Group1 Intervention

Subjects will receive placebo capsule orally starting with a 7-day dose escalation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozanimod

2020

Completed Phase 3

~3510

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 biologics, immunomodulators, and newer agents like sphingosine 1-phosphate receptor modulators. Biologics, such as anti-TNF agents, work by targeting specific proteins involved in the inflammatory process, thereby reducing inflammation and maintaining remission. Immunomodulators like azathioprine and methotrexate suppress the immune system to prevent chronic inflammation. Sphingosine 1-phosphate receptor modulators, such as ozanimod, work by preventing lymphocytes from exiting lymph nodes, reducing their migration to the gut and thus decreasing inflammation. These treatments are crucial for Crohn's Disease patients as they help manage symptoms, induce and maintain remission, and improve quality of life.

Fostering Inflammatory Bowel Disease: Sphingolipid Strategies to Join Forces.