A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2024
• Main ID: NCT04075266
• Date of registration: 14/08/2019
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
• Scientific title: An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
• Date of first enrolment: January 9, 2020
• Target sample size: 36
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04075266
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy, Mexico, Poland, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Body weight >/= 25 kg

- Children and adolescents must have received all childhood required vaccinations

- Female participants of childbearing potential must agree to either remain completely
abstinent or to use reliable means of contraception

- Diagnosis of relapsing-remitting multiple sclerosis (RRMS)

- Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive

- Neurologic stability for >/= 30 days prior to screening, and between screening and
baseline

- Participants naive to prior disease-modifying therapy (DMT)

- Participants who have had at least 6 contiguous months of DMT within the past 1 year
must have evidence of disease activity occurring after the full 6-month course of
treatment, that is, at least one relapse or >/= 1 Gd-enhancing lesion(s) on a
T1-weighted brain MRI

Exclusion Criteria:

- Known presence or suspicion of other neurologic disorders that may mimic MS,
including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis
optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or
metabolic condition that could interfere with brain function or normal cognitive or
neurological development

- Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG)
antibody positive are not eligible to participate in the study.

- In case of an ADEM-like appearance of the first MS attack, a second attack with clear
MS-like features is required.

- Infection requiring hospitalization or treatment with IV anti-infective agents

- History or known presence of recurrent or chronic infection (e.g., HIV, syphilis,
tuberculosis)

- Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment
allocation

- History or laboratory evidence of coagulation disorders

- Peripheral venous access that precludes IV administration and venous blood sampling

- Inability to complete a magnetic resonance imaging (MRI) scan

- History of cancer, including solid tumors, hematologic malignancies, and carcinoma in
situ

- History of a severe allergic or anaphylactic reaction to humanized or murine
monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab
solution

- Previous treatment with B-cell-targeted therapies

- Percentage of CD4 < 30%

- Absolute Neutrophil Count < 1.5x1000/microliter

- Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific
reference range



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

Serum Concentration of Ocrelizumab [Time Frame: 6 months, Up to 5 years]

Levels of CD19+ B-cell Count in Blood [Time Frame: 6 months, Up to 5 years]

Secondary Outcome(s)

Antibody Titers Against Standard Vaccines [Time Frame: 6 months, Up to 5 years]

Level of Circulating White Blood Cells (WBC) [Time Frame: 6 months, Up to 5 years]

Developmental Milestones: Bone age assessment by wrist/hand radiographs [Time Frame: 6 months, Up to 5 years]

Proportion of Participants with Adverse Events [Time Frame: 6 months, Up to 5 years]

Developmental Milestones - Growth velocity: Height. Change in height measured in centimeters (cm) [Time Frame: 6 months, Up to 5 years]

Levels of Blood Immunoglobulins [Time Frame: 6 months, Up to 5 years]

Percentage of Participants with Anti-Drug Antibodies (ADAs) to Ocrelizumab [Time Frame: 6 months, Up to 5 years]

Developmental Milestones: Male and female puberty assessed by Tanner staging [Time Frame: 6 months, Up to 5 years]

Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI) [Time Frame: 6 months, Up to 5 years]

Developmental Milestones: Age at menarche, related with the female reproductive status [Time Frame: 6 months, Up to 5 years]

Secondary ID(s)

2016-002667-34

WA39085

Source(s) of Monetary Support

Please refer to primary and secondary sponsors