Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.

Phase 1

• Conditions: Multiple Sclerosis in pediatric patients; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-002700-39-HR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-06
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

-Signed informed consent/assent must be obtained prior to participation in the study
-Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
-A diagnosis of MS as defined by the consensus definition for pediatric MS
-Expanded Disability Status Scale (EDSS) score of 0 to 5.5 (inclusive) at screening
-At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior to screening or evidence of one or more new T2 lesions compared to prior MRI conducted within 12 months prior to randomization (including screening MRI) or one or more Gd-enhancing
T1 lesions on MRI conducted within 12 months prior to randomization
-Other protocol-defined inclusion/exclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Participants with progressive MS
-Participants meeting the definition of ADEM
-Participants meeting criteria for neuromyelitis optica or tested positive for aquaporin 4 (AQP4) at Screening
-Participants tested positive for anti-MOG at Screening
-Participants with widespread and symmetric white matter alterations in the Screening MRI suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders)
-Homozygosity for CYP2C9*3, or refusal to test for CYP2C9
-Participants with an active, chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g. Sjögren’s disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (Acquired immunodeficiency syndrome (AIDS), hereditary immunodeficiency, drug-induced immunodeficiency ) or tested positive for HIV at Screening
-Participants with neurological symptoms consistent with progressive multifocal leukoencephalopathy (PML) or confirmed PML
-Participants diagnosed with macular edema during the Screening period -Participants with severe active systemic bacterial, viral or fungal infections, including tuberculosis
-Participants with any severe cardiac disease or significant findings on the screening ECG
Any history of malignancy of any organ system
-Participants treated with any of the listed medication as Exclusion Medication within defined timespan
-Positive results of screening period testing for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
-Any other clinically significant laboratory assessment as determined by the Investigator (e.g. significant anemia, neutropenia, thrombocytopenia, signs of impaired bone marrow function
-Have received any live or live-attenuated vaccines (including for varicellazoster virus or measles) within 4 weeks prior to first study drug administration
-Participants without acceptable evidence of immunity to varicella-zoster virus, mumps, measles, rubella, diphtheria, tetanus and pertussis at Randomization
-Participants with any other significant condition, as assessed by the investigator, which may preclude participant from participating in the study.
-Pregnant or nursing (lactating) female participant
-other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified