Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408259
• Other study ID #: IM047-050
• Secondary ID: 2022-501332-42U1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 9, 2024
• Est. completion date: July 13, 2036

Study information

• Verified date: May 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: July 13, 2036
• Est. primary completion date: April 11, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.

• Meets at least 1 of the following criteria for disease activity:

i) At least 1 MS relapse/attack in the previous year prior to screening.

ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.

iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).

• Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

Exclusion Criteria:

• Diagnosis of progressive forms of MS.

• Active or chronic disease of the immune system other than MS.

• Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Ozanimod
Specified dose on specified days
• Fingolimod
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Washington University	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital San Francisco	San Francisco	California
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized relapse rate (ARR)		Up to 2 years
Secondary	Proportion of participants who did not have a confirmed relapse		At 12 and 24 months
Secondary	Number of gadolinium enhancing (GdE) T1 lesions		At month 6 and month 12
Secondary	Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences		At 6, 12, 18, and 24 months
Secondary	Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period		Up to 87 months
Secondary	Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period		Up to 87 months
Secondary	Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period		Up to 87 months
Secondary	Steady state plasma concentrations of ozanimod		At day 90
Secondary	Steady state plasma concentrations of the primary active metabolite CC112273		At day 90
Secondary	Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count		At day 90 and throughout the study up to 24 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls