Study Comparing the Effects of Ozanimod and Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying a condition called Relapsing Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where patients experience episodes of new or worsening symptoms followed by periods of recovery. The study will compare the effectiveness and safety of two oral medications: Ozanimod and Fingolimod. Ozanimod is being tested in different doses, including 0.23 mg, 0.0575 mg, 0.25 mg, and 1 mg, and is also known by the code name RPC1063. Fingolimod is another medication used to treat RRMS.

The purpose of the study is to determine if Ozanimod is effective compared to Fingolimod in treating children and adolescents with RRMS. Participants will take either Ozanimod, Fingolimod, or a placebo. The study will monitor the rate of MS relapses over a period of two years and will also look at the overall health and any side effects experienced by the participants. The study will include a core phase and an extension phase, where participants who complete the core phase may continue to be monitored in the extension phase.

Throughout the study, participants will undergo regular check-ups to assess their condition and the amount of Ozanimod in their bodies. The study aims to provide valuable information on the safety and effectiveness of these treatments for RRMS in young patients. The estimated end date for the study is July 3, 2036.

1 joining the study

Upon joining the study, the participant is diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS).

The participant must have experienced at least one MS relapse in the previous year or two relapses in the past two years, or show evidence of growth in an MRI within six months.

The participant’s Expanded Disability Status Scale (EDSS) score should be between 0 and 5.5.

The participant must be able to swallow capsules.

2 core phase

The core phase involves taking medication to assess the rate of MS relapse over two years.

Participants will receive either Ozanimod or Fingolimod orally.

Ozanimod is administered in different dosages: 0.23 mg, 1 mg, 0.0575 mg, and 0.25 mg in sprinkle or hard capsule form.

Fingolimod is available in 0.25 mg and 0.5 mg hard capsules.

The primary goal is to compare the effectiveness of Ozanimod against Fingolimod.

3 monitoring and assessment

Throughout the core phase, the participant’s condition is monitored to assess the proportion of those with worsening or improving RRMS.

The occurrence of any adverse events, including their type, severity, and relationship to the study drug, is recorded.

Measurements of the amount of Ozanimod in the participant’s body are taken.

4 extension phase

Participants who complete the core phase may enter the extension phase.

The extension phase continues to monitor the participant’s condition and any adverse events.

The study aims to gather long-term data on the safety and effectiveness of the medications.

5 completion

The study is estimated to end by July 3, 2036.

Participants’ data will contribute to understanding the long-term effects and safety of Ozanimod and Fingolimod in treating RRMS.

Who Can Join the Study?

Must have a diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), which is a type of multiple sclerosis where symptoms come and go.
Must have had at least one MS relapse (a return of symptoms) in the past year, or two relapses in the past two years, or show evidence of new growths in the brain on an MRI (a type of scan) within the last six months.
Must have a score between 0 and 5.5 on the Expanded Disability Status Scale (EDSS), which is a way to measure how much MS affects your daily life.
Must be able to swallow a capsule.
Must complete the initial part of the study to join the extension phase.
Both males and females can participate.
Participants can be from vulnerable populations, which means they might need extra protection or care.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Spitalul Clinic de Copii “Dr. Victor Gomoiu”	Bucharest	Romania

Other Sites

Site Name	City	Country
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Ospedale San Raffaele S.r.l.	Milan	Italy
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hospital Alvaro Cunqueiro	Vigo	Spain
Nftychdvvkqm Cokjff Oz Letfmw Ihtjkmyx Dd Nksjaudcygat O Ic Blarl Ntcxfm Iavfzoyt Dw Nznoqhvkkstk Skhnnl	Rome	Italy
Cbkmoo Hirlomgzqh E Uzwefczmkdvrp Dk Cwopmor Ekpcsl	Coimbra	Portugal

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	02.09.2024
Poland	Not recruiting	02.09.2024
Portugal	Recruiting	02.09.2024
Romania	Recruiting	02.09.2024
Spain	Recruiting	02.09.2024

Trial locations

Investigated drugs:

Ozanimod is a medication being tested to see if it is effective in treating children and adolescents with relapsing-remitting multiple sclerosis (RRMS). It is taken orally and works by modulating the immune system to reduce the frequency of relapses and slow the progression of the disease.

Fingolimod is another medication used to treat relapsing-remitting multiple sclerosis. It is also taken orally and helps to control the disease by preventing certain immune cells from reaching the brain and spinal cord, which can reduce inflammation and nerve damage. In this study, it is used as a comparison to evaluate the effectiveness of ozanimod.

Investigated diseases:

Relapsing-remitting multiple sclerosis

Relapsing Remitting Multiple Sclerosis – This is a form of multiple sclerosis characterized by episodes of new or increasing neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, individuals may experience symptoms such as fatigue, numbness, vision problems, or difficulty with coordination and balance. These symptoms can vary in severity and duration. After a relapse, there is a remission phase where symptoms may improve or disappear entirely. Over time, some people may experience a gradual worsening of symptoms, even between relapses. The disease progression can be unpredictable, with varying patterns of relapses and remissions.

Trial ID:

2022-501332-42-00

Protocol code:

IM047-050

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing the Effects of Ozanimod and Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

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