A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

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Roche

Status and phase

Active, not recruiting
Phase 1

Conditions

Multiple Sclerosis (MS)

Treatments

Drug: Ocrelizumab
Drug: rHuPH20

Study type

Interventional

Funder types

Industry

Identifiers

NCT03972306
CN41144

Details and patient eligibility

About

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).

Enrollment

134 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
  • Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
  • Absence of relapses for 30 days prior to the screening visit

For the dose escalation phase for participants pretreated with ocrelizumab (Group A):

treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)

  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab.

For female perticipants without reproductive potential:

Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).

Exclusion criteria

  • MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score <2.0 at screening.

Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following:

  • History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
  • History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma)
  • History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
  • History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy.
  • History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome)
  • Neuromyelitis optica
  • History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis).
  • History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 4 patient groups

Group A: Cohorts A1-A4
Experimental group
Description:
Participants (participants pretreated with ocrelizumab) will receive a single injection of subcutaneous (SC) ocrelizumab co-mixed with rHuPH20 in the abdomen. For every new dose level, recruitment will be staggered by enrolling 1 participant in each cohort followed by a 48-hour waiting period to review safety and tolerability data by the Safety Monitoring Committee (SMC) prior to enrolling subsequent participants in the same cohort. Currently, the planned dose escalation steps for patients who enroll in Group A are as follows: Cohort A1: 40 mg of SC ocrelizumab Cohort A2: 200 mg of SC ocrelizumab Cohort A3: 600 mg of SC ocrelizumab Cohort A4: 1200 mg of SC ocrelizumab
Treatment:
Drug: rHuPH20
Drug: Ocrelizumab
Group A: Cohort A5
Experimental group
Description:
In the non-randomized subphase, participants will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.
Treatment:
Drug: rHuPH20
Drug: Ocrelizumab
Group A: Cohort AA
Experimental group
Description:
Participants will receive a single 600-mg dose ocrelizumab by intravenous (IV) infusion
Treatment:
Drug: Ocrelizumab
Group B: Cohorts B1-B4
Experimental group
Description:
Ocrelizumab treatment- naive participants will receive a minimum of 3 patients in Cohort B will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen. Cohort B1: 40 mg of SC ocrelizumab Cohort B2: 200 mg of SC ocrelizumab Cohort B3: 600 mg of SC ocrelizumab Cohort B4: 1200 mg of SC ocrelizumab
Treatment:
Drug: rHuPH20
Drug: Ocrelizumab

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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