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Monoclonal Antibodies

Subcutaneous Ocrelizumab for Multiple Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of study (approximately 5 years)

Awards & highlights

Study Summary

This trial will study a new MS drug to see how well it works, how safe it is, and if it causes an immune reaction.

Who is the study for?

This trial is for individuals with Primary Progressive or Relapsing Multiple Sclerosis as per McDonald 2017 criteria, with an EDSS score of 0-6.5. Participants must not have had a relapse in the last 30 days and women should agree to use contraception or be post-menopausal/surgically sterile. Those previously treated with IV ocrelizumab for at least a year can join.Check my eligibility

What is being tested?

The study tests how the body processes subcutaneous Ocrelizumab injections in people with MS, along with its safety and tolerability. It also looks into the immune response to this medication when administered under the skin rather than intravenously.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with Ocrelizumab may include infusion reactions, infections, lower blood cell counts, and potential liver issues which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PPMS or RMS according to the McDonald 2017 criteria.

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I have been treated with ocrelizumab for at least a year before screening.

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My disability level allows me to walk at least 100 meters without aid or rest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study (approximately 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of study (approximately 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (approximately 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following single IV (intravenous Infusion)administration

Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab following subcutaneous (SC) administration

Incidence of local pain at site of injection assessed using Visual Analog Scale (VAS

+3 more

Secondary outcome measures

Percentage of Participants with Anti-Drug Antibodies (ADAs) to ocrelizumab

Percentage of Participants with Anti-Drug Antibodies (ADAs) to rHuPH20

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group B: Cohorts B1-B4Experimental Treatment2 Interventions

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

Group II: Group A: Cohorts A1-A4Experimental Treatment2 Interventions

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

Group III: Group A: Cohort AAExperimental Treatment1 Intervention

Participants will receive a single 600-mg dose ocrelizumab by intravenous (IV) infusion

Group IV: Group A: Cohort A5Experimental Treatment2 Interventions

In the non-randomized subphase, participants will receive a single SC injection of ocrelizumab co-mixed with rHuPH20 in the abdomen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ocrelizumab

2016

Completed Phase 3

~5730

rHuPH20

2008

Completed Phase 2

~650

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,920 Total Patients Enrolled

34 Trials studying Multiple Sclerosis

24,895 Patients Enrolled for Multiple Sclerosis

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,368 Total Patients Enrolled

35 Trials studying Multiple Sclerosis

18,222 Patients Enrolled for Multiple Sclerosis

Media Library

Ocrelizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03972306 — Phase 1

Multiple Sclerosis Research Study Groups: Group A: Cohorts A1-A4, Group A: Cohort A5, Group A: Cohort AA, Group B: Cohorts B1-B4

Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT03972306 — Phase 1

Ocrelizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03972306 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room for further participants in this research endeavor?

"According to clinicaltrials.gov, this medical trial is no longer open for recruits; it was created on August 12th 2019 and last revised October 4th 2022. However, there are still 619 other studies that need participants right now."

Answered by AI

Has this experimental protocol ever been tested before?

"Ocrelizumab has been subject to research since 2008, when the pioneering clinical trial was launched under sponsorship of Genentech Inc. Subsequent Phase 2 approval and 70 currently operational trials across 1100 municipalities in 69 nations confirms Ocreilzumab's standing as a viable pharmaceutical solution."

Answered by AI

Has the promising drug Ocrelizumab been tested in any other clinical experiments?

"Ocrelizumab was first examined by CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge back in 2008. There are currently 70 ongoing clinical trials and 56 completed ones, with the majority of them being held at Alexandria, Louisiana."

Answered by AI

Is eligibility for the clinical trial extended to individuals aged 50 or above?

"Patients between the age of 18 and 65 are eligible to enroll in this medical trial. Additionally, there are 51 trials for minors and 443 studies open to seniors."

Answered by AI

In what scenarios is Ocrelizumab commonly prescribed?

"Ocrelizumab is a frequently prescribed intervention for breast cancer, but it can also be deployed to address drug extravasation, elevated potential of relapse, and primary immunodeficiencies (PID)."

Answered by AI

Has the FDA granted permission for Ocrelizumab to be lawfully administered?

"Ocrelizumab has only been studied in Phase 1 trials, so its safety rating is a conservative 1. Currently available evidence suggests efficacy and minimal risks."

Answered by AI

How many people are participating in this clinical investigation?

"This particular clinical trial is not presently enrolling patients. Its listing was initially posted on August 12th 2019, last updated October 4th 2022. At the current moment there are 549 trials for Multiple sclerosis actively recruiting and 70 studies for Ocrelizumab similarly in search of candidates."

Answered by AI

Is there a way for me to participate in this experiment?

"This medical trial is open to 135 individuals from ages 18-65 years old who have been diagnosed with multiple sclerosis. The required criteria for admission include having an EDSS score between 0-6.5, no relapses in the past 30 days prior to screening, and for women post-menopausal or on hormone therapy/surgically sterile (eg hysterectomy)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03972306.

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