Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04035005) enrolled around 505–508 people in the ocrelizumab group and 508 in the placebo group during the main double-blind phase. The trial was looking at a condition involving progressive disability — most likely primary progressive multiple sclerosis — and was primarily measuring how long it took before participants showed a meaningful, confirmed worsening in their disability. This worsening was tracked using two tools: a standard neurological scoring scale (where higher scores mean more disability) and a timed hand-and-arm test (where taking longer to complete it signals a decline). The trial also followed some participants through later open-label and follow-up phases. The reported data shows that, for the main (primary) outcome — time until a confirmed disability worsening sustained over at least 12 weeks — the ocrelizumab group reached that milestone at a reported median of approximately 204.9 weeks, while the placebo group reached it at approximately 133.6 weeks. For a separate subgroup analysis based on MRI activity, the data was not reported for the ocrelizumab group, while the placebo subgroup recorded 124.9 weeks. For the secondary outcomes, the reported data shows that time to a confirmed worsening on the hand-and-arm test alone (held for 12 weeks) was around 204.9 weeks for ocrelizumab and 203.3 weeks for placebo; for the neurological disability score alone (12 weeks), no value was reported for the ocrelizumab group, while placebo was 155.7 weeks. Similar patterns were reported for the 24-week versions of these measures, with some figures again not reported for the ocrelizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Multiple Sclerosis Trial, Active, Not Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Your MS disability level (measured by a standard scale called EDSS) must be between 3.0 and 8.0 at the start of the trial
- How long you have had MS symptoms matters and depends on your disability level: less than 10 years if your EDSS score is 5.0 or below; less than 15 years if your score is between 5.5 and 6.5; or less than 20 years if your score is between 7.0 and 8.0
- You must have a past or current spinal fluid test result showing certain markers of MS-related immune activity (elevated IgG index or oligoclonal bands) (confirm with trial site)
- You must be able to complete a standard hand-function test (picking up pegs) in more than 25 seconds on average across both hands, but within 240 seconds per hand
- Your neurological condition must have been stable for at least 30 days before the trial starts
- If you have previously taken medicines that affect the immune system for MS, you must have stopped them long enough ago, as specified for each drug
- Women who could become pregnant must agree to use reliable contraception or remain abstinent during treatment and for 6 or 12 months after the last dose
- Women who cannot become pregnant (due to surgery or menopause, and not currently on hormone therapy for menopause) may also be eligible
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have been diagnosed with relapsing-remitting or secondary progressive MS
- People who currently have a serious active infection, including bacterial, viral, fungal, or tuberculosis infections
- People who have had, or are suspected to have had, a serious brain infection called PML (progressive multifocal leukoencephalopathy)
- People with a known active cancer, or who are being monitored for cancer returning
- People with a weakened immune system
- People who received a live vaccine within 6 weeks before joining the trial
- People who cannot have an MRI scan, or who cannot receive the contrast dye used during MRI
- People who need MS symptom treatments or physiotherapy but are not yet on a stable routine, or who have started such treatments within 4 weeks of the trial start
- People who cannot take the pre-medications given before the trial drug infusion due to uncontrolled psychosis (affects steroid use) or closed-angle glaucoma (affects antihistamine use)
- People with other known neurological conditions
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 6 to 12 months after the last dose
- People without suitable vein access for an intravenous infusion
- People with significant uncontrolled conditions affecting the heart, lungs, kidneys, liver, hormonal system, or digestive system
- People with any condition requiring long-term steroid or immune-suppressing medicines
- People with a history of alcohol or drug misuse
- People with a history of immune deficiency conditions
- People who have taken part in another clinical trial or used an experimental treatment within approximately 24 weeks before screening, or within 5 half-lives of that drug (whichever is longer)
- People who have previously been treated with therapies that target B-cells (a type of immune cell)
- People who have had a bone marrow or stem cell transplant
- People who have had any organ transplant or taken anti-rejection medicines
- People who have received intravenous immunoglobulin (IV Ig) or plasma exchange treatment within 12 weeks before joining
- People who have taken systemic steroid medicines within 4 weeks before screening
- Women with a positive pregnancy test at screening or at the start of the trial
- People who test positive for hepatitis B
- People who do not show signs of MS activity on their MRI scan, if a certain number of participants without MRI activity have already been enrolled (confirm with trial site)
For the later open-label extension phase of the trial (confirm with trial site):
- You must have completed or still be taking part in the first 144-week phase of the trial, and your doctor must feel you could benefit from continuing the treatment
- The same pregnancy and contraception requirements listed above apply
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS; Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set
Other options
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.