What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease include Sphingosine 1-Phosphate Receptor Modulators like Ozanimod, which can cause headache, elevated liver enzymes, and increased risk of infections. Anti-TNF agents, another common treatment, are associated with risks such as infections, malignancies, and potential adverse effects on wound healing. Immunomodulators like azathioprine and 6-mercaptopurine can lead to lymphopenia, anemia, liver enzyme elevation, and increased infection risk. Corticosteroids, often used for their anti-inflammatory effects, can cause weight gain, osteoporosis, hypertension, and increased susceptibility to infections.

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 and adalimumab 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 currently being studied for Crohn's Disease, it is already approved for multiple sclerosis, indicating its potential for immune modulation in inflammatory conditions. Other similar treatments include ustekinumab, an IL-12 and IL-23 antagonist, and risankizumab, an IL-23 inhibitor, both of which target specific pathways in the immune response.

What other types of research exist?

Promising novel alternatives to Ozanimod for Crohn's Disease patients include anti-IL-23 agents, JAK inhibitors, anti-integrins, and other S1P modulators. These therapies are in advanced stages of clinical development and have shown potential in addressing unmet medical needs in Crohn's Disease.

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Sphingosine 1-phosphate receptor modulator

Ozanimod for Crohn's Disease

Q: What is the mechanism of action of this treatment?

Common treatments for Crohn's Disease include biologics, immunomodulators, and newer agents like sphingosine 1-phosphate receptor modulators. Biologics, such as infliximab and adalimumab, target specific proteins like TNF-alpha to reduce inflammation. Immunomodulators, including azathioprine and methotrexate, suppress the immune system to prevent chronic inflammation. Sphingosine 1-phosphate receptor modulators, like ozanimod, work by modulating the migration of lymphocytes, thereby reducing inflammation in the gastrointestinal tract. Understanding these mechanisms is crucial for patients as it helps tailor treatment plans to effectively manage symptoms and maintain remission, improving overall quality of life.

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

Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies

Be older than 18 years old

Must not have

Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated

Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 264 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing ozanimod, a medication that helps reduce inflammation, in people with severe Crohn's Disease who may not respond to usual treatments. Ozanimod has been approved for the treatment of ulcerative colitis and is being tested for its effectiveness in Crohn's disease.

Who is the study for?

This trial is for people with moderate to severe Crohn's Disease who have finished a previous ozanimod study but are not in remission or response after 12 weeks, or those who relapsed post-study. Participants should not have untreated abscesses and must not be on certain drugs like CYP2C8 inducers or MAO inhibitors.

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called Ozanimod for individuals with Crohn's Disease. It extends prior research by continuing treatment with this medication to see how well it works over a longer period.

What are the potential side effects?

While specific side effects for this trial aren't listed, Ozanimod may generally cause infections, liver problems, blood pressure changes, breathing issues, and heart rate irregularities based on its action in the body.

Eligibility Criteria

Inclusion Criteria

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

Select...

My condition did not improve after 12 weeks in the initial treatment study.

Exclusion Criteria

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

Select...

I might have an untreated abscess in my abdomen or near my anus.

Select...

I am currently taking drugs that affect enzyme activity or treat depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 264 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 264 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 264 weeks 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 a CDAI score of < 150

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of oral OzanimodExperimental Treatment1 Intervention

Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 48 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozanimod

2020

Completed Phase 3

~3510

0 / 3Eligibility 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 infliximab and adalimumab, target specific proteins like TNF-alpha to reduce inflammation. Immunomodulators, including azathioprine and methotrexate, suppress the immune system to prevent chronic inflammation. Sphingosine 1-phosphate receptor modulators, like ozanimod, work by modulating the migration of lymphocytes, thereby reducing inflammation in the gastrointestinal tract. Understanding these mechanisms is crucial for patients as it helps tailor treatment plans to effectively manage symptoms and maintain remission, improving overall quality of life.

Metabolic Host-Microbiota Interactions in Autophagy and the Pathogenesis of Inflammatory Bowel Disease (IBD).Fostering Inflammatory Bowel Disease: Sphingolipid Strategies to Join Forces.