194 Participants Needed

Ozanimod vs Fingolimod for Multiple Sclerosis

Recruiting at 35 trial locations
BS
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Celgene
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

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.

What data supports the effectiveness of the drug Ozanimod compared to Fingolimod for multiple sclerosis?

Fingolimod is an effective oral drug for relapsing multiple sclerosis, reducing relapses by about half compared to placebo. Ozanimod, another drug for the same condition, shows a favorable safety profile with fewer side effects and similar effectiveness compared to Fingolimod.12345

What is the safety profile of Ozanimod and Fingolimod for multiple sclerosis?

Ozanimod generally has a better safety profile than Fingolimod, with fewer risks of heart-related issues, infections, and liver problems. Fingolimod can cause fatigue, headaches, and more serious issues like heart block and eye problems, but these are rare.25678

How does the drug ozanimod differ from fingolimod for multiple sclerosis?

Ozanimod is associated with fewer side effects compared to fingolimod, such as a lower risk of heart-related issues and liver enzyme abnormalities. It also has a more favorable safety profile, with fewer adverse events and infections over a two-year period.356910

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Fingolimod
  • Ozanimod
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: OzanimodExperimental Treatment2 Interventions
Group II: FingolimodActive Control2 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

Find a Clinic Near You

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 profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

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.
Fingolimod for multiple sclerosis.[2015]
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.
Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis.Zarbin, MA., Jampol, LM., Jager, RD., et al.[2022]
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.
Fingolimod for the treatment of relapsing multiple sclerosis.Singer, BA.[2015]

References

Fingolimod for multiple sclerosis. [2015]
Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. [2022]
Real-world incidence of fingolimod-associated macular oedema. [2021]
Fingolimod for the treatment of relapsing multiple sclerosis. [2015]
Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis. [2021]
Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. [2015]
Fingolimod in the treatment of relapsing-remitting multiple sclerosis: long-term experience and an update on the clinical evidence. [2023]
Overview and safety of fingolimod hydrochloride use in patients with multiple sclerosis. [2015]
Cryptococcal meningoencephalitis in an IgG2-deficient patient with multiple sclerosis on fingolimod therapy for more than five years - case report. [2020]
Delayed fingolimod-associated asystole. [2022]