Clinical trial NCT06408259: Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Relapsing-Remitting
Ozanimod
Zeposia®
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-05-10
Enrollment: 194
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Annualized relapse rate (ARR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Proportion of participants who did not have a confirmed relapse
timeFrame: At 12 and 24 months
measure: Number of gadolinium enhancing (GdE) T1 lesions
timeFrame: At month 6 and month 12
measure: Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences
timeFrame: At 6, 12, 18, and 24 months
measure: Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period
timeFrame: Up to 87 months
measure: Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period
timeFrame: Up to 87 months
measure: Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period
timeFrame: Up to 87 months
measure: Steady state plasma concentrations of ozanimod
timeFrame: At day 90
measure: Steady state plasma concentrations of the primary active metabolite CC112273
timeFrame: At day 90
measure: Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count
timeFrame: At day 90 and throughout the study up to 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Local Institution - 0110
state: Arizona
city: Loma Linda
country: United States
facility: Local Institution - 0114
state: California
city: Sacramento
country: United States
facility: Local Institution - 0130
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital San Francisco
state: California
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Local Institution - 0093
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 0055
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cincinnati
country: United States
facility: Local Institution - 0091
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0092
state: Oregon
city: Milwaukee
country: United States
facility: Local Institution - 0033
state: Wisconsin
city: Melbourne
country: Australia
facility: Local Institution - 0113
state: Victoria
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Rome
country: Italy
facility: Neurological Center Of Latium
state: Roma
city: Mexico City
country: Mexico
facility: Local Institution - 0078
state: DIF
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
state: Wielkopolskie
city: Braga
country: Portugal
facility: 2Ca Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário De Coimbra
city: Lisboa
country: Portugal
facility: Local Institution - 0104
city: Porto
country: Portugal
facility: Local Institution - 0102
city: Bucharest
country: Romania
facility: Local Institution - 0088
state: București
city: Bucharest
country: Romania
facility: Prof. Dr. Alexandru Obregia Psychiatry Hospital
state: București
city: Esplugues de Llobregat
country: Spain
facility: Local Institution - 0096
state: Barcelona [Barcelona]
city: Vigo
country: Spain
facility: Local Institution - 0098
state: Pontevedra [Pontevedra]
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Local Institution - 0101
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Samsun
country: Turkey
facility: Local Institution - 0109
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: