In short
This article discusses a Phase 3 clinical trial investigating the use of Ozanimod Hydrochloride in children and adolescents with Relapsing-Remitting Multiple Sclerosis (RRMS). The study aims to compare the efficacy, safety, and other important factors of Ozanimod with Fingolimod, another medication used to treat RRMS. This trial is significant as it explores treatment options for younger patients with this challenging neurological condition.
At a glance
- Study Type
- Phase 3, Multicenter, Double Blind, Active-Controlled
- Participants
- Children and Adolescents with Relapsing Remitting Multiple Sclerosis
- Main Objective
- Compare efficacy of Ozanimod to Fingolimod
- Primary Endpoint
- Rate of MS relapse over 2 years
- Secondary Objectives
- Efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics
- Inclusion Criteria
- RRMS diagnosis, recent relapses or MRI evidence, EDSS 0-5.5
- Exclusion Criteria
- Progressive MS, immune system diseases, major body diseases, seizures, substance abuse
- Drug Forms
- Sprinkle capsules and hard capsules of various strengths
- Administration Route
- Oral use
What is Ozanimod Hydrochloride?
Ozanimod Hydrochloride is a medication being studied for the treatment of relapsing-remitting multiple sclerosis (RRMS) in children and adolescents. It is also known by its product code BMS-986374 or RPC1063. Ozanimod is taken orally, which means it can be swallowed as a capsule.
What Medical Condition Does Ozanimod Treat?
Ozanimod is being investigated as a treatment for Relapsing-Remitting Multiple Sclerosis (RRMS). RRMS is a type of multiple sclerosis characterized by periods of new or worsening symptoms (relapses) followed by periods of recovery (remission). It's important to note that this medication is specifically being studied for use in children and adolescents with RRMS, as there is a need for effective treatments in this age group.
How Does Ozanimod Work?
While the exact mechanism of action is not detailed in the provided information, Ozanimod belongs to a class of drugs known as sphingosine 1-phosphate receptor modulators. These medications work by preventing certain immune cells from leaving the lymph nodes, which can reduce inflammation and damage in the central nervous system that occurs in multiple sclerosis.
Current Clinical Trial for Children and Adolescents
A Phase 3 clinical trial is currently underway to evaluate Ozanimod in children and adolescents with RRMS. This study is comparing Ozanimod to another medication called Fingolimod, which is already approved for treating RRMS. The study is designed to assess several aspects:
- How effective Ozanimod is compared to Fingolimod
- The safety and tolerability of Ozanimod
- How the body processes Ozanimod (pharmacokinetics)
- How Ozanimod affects the body (pharmacodynamics)
Who Can Participate in the Clinical Trial?
The clinical trial has specific criteria for who can participate. Here are some key points:
Inclusion Criteria:
- Diagnosis of RRMS
- Recent history of MS relapses or evidence of disease activity on MRI
- An Expanded Disability Status Scale (EDSS) score between 0 and 5.5 (This scale measures the degree of disability in MS)
- Ability to swallow capsules
Exclusion Criteria:
- Diagnosis of progressive forms of MS
- Active or chronic diseases of the immune system
- Certain cardiovascular, liver, neurological, or endocrine diseases
- History of cancer
- History of epileptic seizures, substance abuse, or suicide attempts
- Pregnancy or breastfeeding
- Previous treatment with certain types of immunosuppressant therapies
What Are the Objectives of the Study?
The clinical trial has several objectives:
- To assess the rate of MS relapses over a 2-year period
- To determine the proportion of participants whose RRMS improves or worsens
- To monitor for any side effects or adverse events
- To measure how much Ozanimod is present in participants' bodies
Available Dosage Forms
Ozanimod Hydrochloride is available in several dosage forms for this study:
- 0.0575 mg sprinkle capsule
- 0.23 mg sprinkle capsule
- 0.25 mg hard capsule
- 1 mg hard capsule
These different dosage forms allow for flexible dosing based on the patient's needs and tolerability.
Safety Considerations
As with any medication, there are important safety considerations to keep in mind:
- The study will closely monitor for any side effects or adverse events.
- Participants will be regularly assessed for any worsening of their condition.
- The study includes measures to track early discontinuation, which could be due to side effects or lack of efficacy.
- Certain medical conditions and previous treatments may exclude individuals from participating, to ensure their safety.
It's important to note that as this is a clinical trial, not all potential risks and benefits of Ozanimod are known. The study aims to gather more information about its safety and effectiveness in children and adolescents with RRMS.