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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075266
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 2-year study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages >/= 10 to < 18 years with relapsing-remitting multiple sclerosis (RRMS). The first 24-week period will serve to determine the dose of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Ocrelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : May 26, 2021
Estimated Study Completion Date : August 12, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Cohort 1
Participants with a body weight from >/= 25 kg to < 40 kg (with at least 2 participants with a body weight from >/= 25 kg to </= 35 kg) will receive 300 milligram (mg) ocrelizumab
Drug: Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.

Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg


Experimental: Cohort 2
Participants with a body weight >/= 40 kg (with at least 2 participants with a body weight >/= 40 kg but </= 50 kg) will receive 600 mg ocrelizumab
Drug: Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.

Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg


Experimental: Cohort 3 (optional)
Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight from >/= 25 kg to < 40 kg may be enrolled and receive another dose level of ocrelizumab
Drug: Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.

Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg


Experimental: Cohort 4 (optional)
Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight >/= 40 kg may be enrolled and receive another dose level of ocrelizumab
Drug: Ocrelizumab

Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.

Cohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg





Primary Outcome Measures :
  1. Serum Concentration of Ocrelizumab [ Time Frame: 6 months, Up to 5 years ]
  2. Levels of CD19+ B-cell Count in Blood [ Time Frame: 6 months, Up to 5 years ]

Secondary Outcome Measures :
  1. Proportion of Participants with Adverse Events [ Time Frame: 6 months, Up to 5 years ]
    Severity of adverse events is determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  2. Level of Circulating White Blood Cells (WBC) [ Time Frame: 6 months, Up to 5 years ]
    WBC include B cells, T cells, natural killer (NK) cells and other leukocytes

  3. Developmental Milestones - Growth velocity: Height. Change in height measured in centimeters (cm) [ Time Frame: 6 months, Up to 5 years ]
  4. Developmental Milestones: Bone age assessment by wrist/hand radiographs [ Time Frame: 6 months, Up to 5 years ]
    Bone age should be reported according to the Greulich and Pyle Atlas (Greulich and Pyle, 1959)

  5. Developmental Milestones: Male and female puberty assessed by Tanner staging [ Time Frame: 6 months, Up to 5 years ]
    Tanner stages (stages 1 to 5) (Tanner, 1986)

  6. Developmental Milestones: Age at menarche, related with the female reproductive status [ Time Frame: 6 months, Up to 5 years ]
    This milestone is recorded as date of menarche (day, month, year)

  7. Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: 6 months, Up to 5 years ]
  8. Levels of Blood Immunoglobulins [ Time Frame: 6 months, Up to 5 years ]
  9. Antibody Titers Against Standard Vaccines [ Time Frame: 6 months, Up to 5 years ]
    Measurement of antibody titers to common antigens (mumps, rubella, varicella, S. pneumoniae)

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075266


Contacts
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Contact: Reference Study ID Number: WA39085 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04075266    
Other Study ID Numbers: WA39085
2016-002667-34 ( EudraCT Number )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs