Clinical trial • Phase III • Neurology
ozanimod hydrochloride for Relapsing-remitting multiple sclerosis
Phase III trial of ozanimod hydrochloride for Relapsing-remitting multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Relapsing-remitting multiple sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 24-05-2024
- First CTIS Authorization Date
- 11-09-2024
Trial design
Randomised, fingolimod (oral). product entries list fingolimod strengths (fingolimod 0.25 mg capsule, fingolimod 0.5 mg capsule); fingolimod is over-encapsulated to blind vs placebo. (no detailed schedule provided in the available data.)-controlled Phase III trial across 15 sites in Poland, Portugal, Spain and others.
- Randomised
- Yes
- Comparator
- Fingolimod (oral). Product entries list fingolimod strengths (Fingolimod 0.25 mg capsule, Fingolimod 0.5 mg capsule); fingolimod is over-encapsulated to blind vs placebo. (No detailed schedule provided in the available data.)
- Target Sample Size
- 40
- Trial Duration For Participant
- 730
Eligibility
Recruits 40 paediatric patients.
- Pregnancy Exclusion
- Core and Extension Phase: Pregnant or breastfeeding females
- Vulnerable Population
- Vulnerable population includes children and adolescents. Age-specific assent and consent procedures are provided: assent and information sheets for minors (documents for 10-11 yrs, 12-15 yrs, 13-17 yrs), parent/guardian consent forms, and age-of-majority consent documents; subject information and informed consent forms available in country/language-specific versions.
Inclusion criteria
- {"criterion_text":"- Core Phase: Diagnosis of MS with a RRMS\n- Core Phase: 1 MS relapse in the previous year or 2 MS relapse in past 2 years or evidence of 1 or more growth in MRI within 6 months\n- Core Phase: 0 - 5.5 Expanded Disability Status Scale (EDSS)\n- Core Phase: Must be able to swallow capsule\n- Extension Phase: Completion of core phase"}
Exclusion criteria
- {"criterion_text":"- Core and Extension phase: Diagnosis of progressive form of MS\n- Core and Extension Phase: Active or chronic disease of the immune system\n- Core and Extension Phase: Any cardiovascular, liver, neurological, endocrine, or other major body disease or history or presence of malignancy\n- Core and Extension Phase: History of any type of epileptic seizures, substance abuse, progressive neurological disorder, or history of suicide attempt\n- Core and Extension Phase: Pregnant or breastfeeding females\n- Core and Extension Phase: Previous treatment with certain lymphocyte-depleting therapies or other immunosuppressants\n- Core and Extension Phase: Discontinued treatment with fingolimod or similar modulator, due to the medication not working"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Core phase: To assess rate of Multiple Sclerosis (MS) relapse over 2 years","definition_or_measurement_approach":"Assess rate of Multiple Sclerosis (MS) relapse over a 2-year period (as stated: 'To assess rate of Multiple Sclerosis (MS) relapse over 2 years')."}
Secondary endpoints
- {"endpoint_text":"- Core and Extension Phase: proportion of the participants who have worsening or improving RRMS","definition_or_measurement_approach":"Proportion of participants with worsening or improvement in RRMS (verbatim as listed)."}
- {"endpoint_text":"- Core and Extension Phase: occurrence of adverse events (type, severity and relationship to the study drug)","definition_or_measurement_approach":"Occurrence of adverse events characterized by type, severity and relationship to study drug (verbatim as listed)."}
- {"endpoint_text":"- Core and Extension Phase: early study discontinuation","definition_or_measurement_approach":"Monitoring of early study discontinuation (verbatim as listed)."}
- {"endpoint_text":"- Core and Extension Phase: measurements of the amount of ozanimod in a participant’s body","definition_or_measurement_approach":"Pharmacokinetic measurements of ozanimod levels in participants (verbatim: 'measurements of the amount of ozanimod in a participant’s body')."}
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 142
- Consent Approach
- Informed consent and assent procedures are age-specific: parent/guardian consent required for minors; assent documents provided for younger participants (documents for 10-11 yrs, 12-15 yrs, 13-17 yrs are listed). Age-of-majority consent documents and parent information/consent templates are available. Subject information and informed consent forms are provided in multiple country/language versions (examples in Polish, Portuguese, Spanish, Italian and English-language materials are present in the document list).
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 38
Poland
- Earliest CTIS Part Ii Submission Date
- 03-09-2024
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 430
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Kliniczny Neurologii Dzieci i Młodzieży
- Principal Investigator Name
- Barbara Steinborn
- Contact Person Name
- Barbara Steinborn
- Contact Person Email
- bstein@ump.edu.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 441
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Centro de Responsabilidade Integrado de Esclerose Múltipla da ULS São José
- Principal Investigator Name
- João Sequeira
- Contact Person Name
- João Sequeira
- Contact Person Email
- joaopfsequeira@gmail.com
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Centro de Desenvolvimento da Criança - Neuropediatria
- Principal Investigator Name
- Filipe Palavra
- Contact Person Name
- Filipe Palavra
- Contact Person Email
- filipepalavra@gmail.com
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Neuropediatria
- Principal Investigator Name
- Mafalda Sampaio
- Contact Person Name
- Mafalda Sampaio
- Contact Person Email
- centro.investigacao@chsj.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Neurologia
- Principal Investigator Name
- João Cerqueira
- Contact Person Name
- João Cerqueira
- Contact Person Email
- jcerqueira@med.uminho.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 442
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Neurología
- Principal Investigator Name
- Thais Armangue
- Contact Person Name
- Thais Armangue
- Contact Person Email
- thais.armangue@sjd.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurología
- Principal Investigator Name
- Sara Eichau Madueño
- Contact Person Name
- Sara Eichau Madueño
- Contact Person Email
- saraeichau@gmail.com
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- NEUROLOFÍA
- Principal Investigator Name
- ELENA Álvarez
- Contact Person Name
- ELENA Álvarez
- Contact Person Email
- elenaar86@hotmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neuroinmunología
- Principal Investigator Name
- Francisco Carlos Pérez Miralles
- Contact Person Name
- Francisco Carlos Pérez Miralles
- Contact Person Email
- fcomiralles.neuro@gmail.com
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Neurología
- Principal Investigator Name
- JESUS Martin Martinez
- Contact Person Name
- JESUS Martin Martinez
- Contact Person Email
- jesmartin58@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 514
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Dipartimento di Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
- Principal Investigator Name
- Vincenzo Brescia Morra
- Contact Person Name
- Vincenzo Brescia Morra
- Contact Person Email
- vincenzo.bresciamorra@unina.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurologia
- Principal Investigator Name
- Massimo Filippi
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l.
- Department Name
- Neurologia Sperimentazioni Cliniche
- Principal Investigator Name
- Carlo Pozzilli
- Contact Person Name
- Carlo Pozzilli
- Contact Person Email
- carlo.pozzilli@uniroma1.it
Romania
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 606
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Neurology
- Principal Investigator Name
- Cristina Pomeran
- Contact Person Name
- Cristina Pomeran
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Dr. Victor Gomoiu Clinical Children Hospital
- Department Name
- Pediatric Neurology
- Principal Investigator Name
- Raluca Ioana Teleanu
- Contact Person Name
- Raluca Ioana Teleanu
- Contact Person Email
- xyz@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Frontage Laboratories (Shanghai) Co. Ltd.
- Responsibilities
- PK testing and reporting
- Name
- Endpoint Clinical Inc.
- Responsibilities
- Treatment/Arm Assignment; Drug (re) Supplies Assignment; IVRS-treatment
- Name
- Accenture Solutions Private Limited
- Responsibilities
- Operational support (codes/roles listed: 6, 'embarc operations')
- Name
- Clario
- Responsibilities
- Cardiac Safety Analysis; additional data services
- Name
- Signant Health Global LLC
- Responsibilities
- Treatment/Arm assignment; IVRS – treatment randomisation; Drug (re)supplies assignment; Subject Number assignment; PRO/COA
Third parties
- {"country":"China","full_name":"Frontage Laboratories (Shanghai) Co. Ltd.","duties_or_roles":"PK testing and reporting","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Treatment/Arm Assignment; Drug (re) Supplies Assignment; IVRS-treatment","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Code 6 (role code present in record)","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"embarc operations; Code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"Cardiac Safety Analysis; additional roles (codes 6 and 7 present)","organisation_type":"Industry"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Treatment/Arm assignment; IVRS – treatment randomisation; Drug (re)supplies assignment; Subject Number assignment; PRO/COA","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ozanimod HCl
- Active Substance
- ozanimod hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- prodAuthStatus=1
- Dose Levels
- Ozanimod HCl 0.23 mg, Ozanimod HCl 1 mg, Ozanimod HCl 0.0575 mg, Ozanimod HCl 0.25 mg
- Investigational Product Name
- Fingolimod
- Active Substance
- fingolimod
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- prodAuthStatus=2
- Dose Levels
- Fingolimod 0.25 mg capsule, Fingolimod 0.5 mg capsule
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