Ozanimod vs Fingolimod for Multiple Sclerosis

Recruiting at 51 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Celgene

Disqualifiers: Progressive MS, Immune diseases, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of two drugs, ozanimod and fingolimod, for treating children and teens with relapsing-remitting multiple sclerosis (RRMS). The researchers aim to determine which drug works better and is easier to tolerate for those experiencing repeat flare-ups. Children and teens who have had at least one MS attack in the last year or more than one in the last two years may be suitable candidates. This study could identify the best treatment option for managing RRMS in younger patients. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

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

Research has shown that ozanimod is generally safe for people with relapsing forms of multiple sclerosis. Long-term studies indicate it is well-tolerated, with consistent safety results over time. Patients using ozanimod for up to five years reported stable health, with no new safety issues arising, suggesting a dependable safety record.

Fingolimod, the other treatment in this trial, has already received FDA approval for multiple sclerosis, indicating it has undergone thorough safety testing. While any treatment can have side effects, its approval suggests it is generally safe for many people.

Both medications have been studied extensively, so participants in this trial can feel confident that earlier research prioritized their safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for multiple sclerosis?

Researchers are excited about Ozanimod for multiple sclerosis because it offers a different approach from traditional treatments. Unlike the standard care options like Fingolimod, Ozanimod specifically targets the sphingosine-1-phosphate (S1P) receptor with greater selectivity. This selectivity could potentially lead to fewer side effects and improved safety. Additionally, Ozanimod is administered orally, which is convenient compared to some therapies that require injections or infusions. These features make Ozanimod a promising option for enhancing patient quality of life while effectively managing multiple sclerosis.

What evidence suggests that this trial's treatments could be effective for relapsing remitting multiple sclerosis?

This trial will compare Ozanimod and Fingolimod for treating multiple sclerosis. Research has shown that Ozanimod, which participants in this trial may receive, effectively treats relapsing forms of multiple sclerosis (MS). Studies have found that Ozanimod can reduce relapses and limit new or growing brain lesions. Long-term data suggests it helps maintain low and stable rates of brain volume loss over five years. Comparative studies also highlight Ozanimod's strong safety profile and its effectiveness, which matches or surpasses other oral MS treatments.

Fingolimod, another treatment option in this trial, has proven effective for relapsing-remitting multiple sclerosis (RRMS). It reduces the frequency of MS relapses and slows the progression of physical disability. ^{1 5 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for children and adolescents with Relapsing Remitting Multiple Sclerosis (RRMS). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of RRMS.

Inclusion Criteria

My disability level allows me to walk without aid or rest for 200 meters.

I have been diagnosed with relapsing-remitting multiple sclerosis.

I have had at least one MS attack in the last year or a recent MRI showing active disease.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have any major heart, liver, brain, or other systemic diseases.

I have an immune system condition that is not MS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ozanimod or fingolimod to evaluate effectiveness, safety, and tolerability

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fingolimod
• Ozanimod

Trial Overview

The study compares the effectiveness and safety of two drugs: Ozanimod and Fingolimod. Participants will receive either one of these drugs or a placebo to assess how well they work in treating RRMS in young patients.

How Is the Trial Designed?

Group I: Ozanimod Experimental Treatment 2 Interventions

Group II: Fingolimod Active Control 2 Interventions

Fingolimod is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Gilenya for:

• Relapsing forms of multiple sclerosis

Approved in United States as Gilenya for:

• Relapsing forms of multiple sclerosis

Approved in Canada as Gilenya for:

• Relapsing forms of multiple sclerosis

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

In a study involving 2615 patients with relapsing-remitting multiple sclerosis, fingolimod (Gilenya) was associated with a low incidence of macular edema (ME), with only 19 confirmed cases observed, primarily in those receiving the higher dose of 1.25 mg.

Patients with a history of uveitis were found to be at a higher risk for developing ME, highlighting the importance of pre-treatment ophthalmic evaluations and ongoing eye monitoring during fingolimod therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Zarbin, MA., Jampol, LM., Jager, RD., et al.[2022]

Fingolimod is an effective oral treatment for relapsing forms of multiple sclerosis, showing significant reductions in relapse rates and MRI progression compared to placebo and other treatments like IFN-β.

While generally well tolerated, fingolimod can cause common side effects such as fatigue and headaches, and rare but serious risks like heart issues and infections, necessitating careful patient monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview and safety of fingolimod hydrochloride use in patients with multiple sclerosis. Ward, MD., Jones, DE., Goldman, MD.[2015]

Fingolimod (Gilenya) is the first oral disease-modifying treatment approved for patients with highly active relapsing-remitting multiple sclerosis, marking a significant advancement in MS therapy.

This new treatment offers a novel mechanism of action by modulating the immune system, which may improve patient outcomes compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fingolimod for multiple sclerosis. [2015]

Fingolimod (0.5 mg) is the first oral therapy approved for relapsing forms of multiple sclerosis (MS), showing a significant reduction in relapses by about 50% compared to placebo and intramuscular IFN-β1a over extensive clinical trials.

With over 63,000 MS patients monitored for more than 73,000 patient-years, fingolimod has established a well-characterized safety profile, with manageable side effects through proper patient monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fingolimod for the treatment of relapsing multiple sclerosis. Singer, BA.[2015]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01628393

NCT01628393 | Efficacy and Safety Study of Ozanimod ...

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8123972/

An Overview of the Efficacy and Safety of Ozanimod for the ...

Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: results from the DAYBREAK Open-Label Extension Study; 2021.

3.

news.bms.com

news.bms.com/news/details/2024/New-Long-Term-Zeposia-ozanimod-Data-Demonstrate-Durable-Efficacy-and-Consistent-Safety-in-Relapsing-Forms-of-Multiple-Sclerosis/default.aspx

New Long-Term Zeposia (ozanimod) Data Demonstrate ...

These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38855023/

Comparative effectiveness and safety of ozanimod versus ...

Compared with the other oral DMTs evaluated in MAICs, ozanimod was associated with a favorable safety profile and improved or comparable efficacy outcomes.

5.

zeposia.com

zeposia.com/multiple-sclerosis/efficacy-and-study-results

ZEPOSIA® (ozanimod) Clinical Study Results

ZEPOSIA is proven to help protect the brain from the damaging effects of MS by reducing relapses and new or enlarging lesions.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35765217/

Long-term safety and efficacy of ozanimod in relapsing ...

This long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging ...

7.

zeposiahcp.com

zeposiahcp.com/multiple-sclerosis/clinical-data/safety

ZEPOSIA® (ozanimod) MS Safety Profile | HCPs

See ZEPOSIA® safety profile and adverse reactions data in Relapsing Multiple Sclerosis clinical trials. See full safety and Prescribing Information.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2211034821001103

Ozanimod in relapsing multiple sclerosis: Pooled safety ...

Safety results in this larger RMS population with greater ozanimod exposure demonstrated no new safety concerns and were consistent with phase 3 trial results.