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Active, not recruitingNCT04035005O'HANDUpdated Feb 23, 2026Results posted

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

A Phase 3 interventional study of Ocrelizumab and Placebo in Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche. Active, not recruiting at 155 sites in 23 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,013
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).

Read the detailed description

The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 144 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. All participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants receiving other immunomodulatory or immunosuppressive treatment(s) for MS, commercial ocrelizumab, or no treatment. The FU1 phase will run in parallel with the double-blind treatment phase for 144 weeks or until the primary analysis is performed, whichever occurs first. An optional OLE phase is planned for eligible participants who either have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 at 144 weeks from randomization or at the time of the primary analysis; participants who have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and will not enter the OLE phase; participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase.

02

Conditions studied

  • Multiple Sclerosis, Primary Progressive
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • EDSS score at screening and baseline >= 3.0 to 8.0, inclusive
  • Disease duration from the onset of MS symptoms relative to randomization date:

Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening \<= 5.0

  • Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated immunoglobulin G (IgG) index or one or more IgG oligoclonal bands detected by isoelectric focusing
  • Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)
  • Neurological stability for ≥ 30 days prior to baseline
  • Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
  • Neurological stability for >/= 30 days prior to baseline
  • Participants previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female participants without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile

Exclusion criteria

Exclusion Criteria:

  • History of relapsing-remitting or secondary progressive MS at screening
  • Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease
  • Participants who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML)
  • Known active malignancy or are being actively monitored for recurrence of malignancy
  • Immunocompromised state
  • Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
  • Inability to complete an MRI or contraindication to Gd administration.
  • Participants requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Participants must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization.
  • Contraindications to mandatory premedications for infusion-related reactions, including:

uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines

  • Known presence of other neurologic disorders
  • Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug
  • Lack of peripheral venous access
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participant from participating in the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of alcohol or other drug abuse
  • History of primary or secondary immunodeficiency
  • Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
  • Previous treatment with B-cell targeting therapies
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Any previous history of transplantation or anti-rejection therapy
  • Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • Positive serum human chorionic gonadotropin (hCG) measured at screening or positive urine β-hCG at baseline
  • Positive screening tests for hepatitis B
  • Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
  • Lack of MRI activity at screening/baseline if more than 650 participants without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 participants with MRI activity will be randomized

Eligibility Criteria for OLE Phase:

  • Completed the 144 weeks of double-blind treatment phase of the trial or are ongoing in the double blind treatment phase at the time of the primary analysis, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Participants who withdrew from study treatment and received another DMT or commercial ocrelizumab will not be allowed to enter in the OLE phase.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
  • For female participants without reproductive potential: Women may be enrolled if surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,013 participants (actual)

Study arms

  • Experimental
    Ocrelizumab

    Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks.

    Drug: Ocrelizumab

  • Placebo comparator
    Placebo

    Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.

    Drug: Placebo

Interventions

  • DrugOcrelizumab

    The first dose of ocrelizumab will be administered as two 300 milligrams (mg), IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusion, should be maintained between each infusion.

    Also known as: Ocrevus

  • DrugPlacebo

    The first dose of placebo will be administered as two IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusions, maintained between each infusion.

05

What researchers measure

Primary outcomes

  1. Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS

    Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

    Time frame: Up to approximately 243 weeks

  2. Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set

    Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in EDSS score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

    Time frame: Up to approximately 243 weeks

Secondary outcomes

  1. Time to 12-week CDP in 9-HPT

    12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

    Time frame: Up to approximately 243 weeks

  2. Time to 12-week CDP in EDSS

    12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated \& then scored as a functional system scores (FSS), \& ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, \& ambulation score that is rated from 0 to 16. These ratings along with observations \& assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.

    Time frame: Up to approximately 243 weeks

  3. Time to 24-week CDP in 9-HPT

    24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

    Time frame: Up to approximately 243 weeks

  4. Time to 24-week CDP in EDSS

    24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.

    Time frame: Up to approximately 243 weeks

  5. Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions

    Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change.

    Time frame: Up to approximately 120 weeks

  6. Annual Rate of Percent Change From Week 24 in Total Brain Volume

    Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change.

    Time frame: From Week 24 up to approximately 120 weeks

  7. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment.

    Time frame: From initiation of study drug up to approximately 10.5 years

  8. Serum Concentration of Ocrelizumab

    Time frame: Up to approximately 10.5 years

  9. B-cell Levels in Blood

    Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228

  10. Change From Baseline in B-cell Levels

    Time frame: Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228

  11. Percentage of Participants With B-cell Counts ≤5 Cells/μL

    Percentages have been rounded off.

    Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228

  12. Percentage of Participants With B-cell Counts ≤10 Cells/μL

    Percentages have been rounded off.

    Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228

  13. Number of Participants With ADAs to Ocrelizumab

    Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result.

    Time frame: Baseline up to approximately 10.5 years

06

Results

Posted Feb 23, 2026

Participant flow

A total of 1013 participants with primary progressive multiple sclerosis (PPMS) took part in the study at 148 investigative sites across 23 countries. Participants were randomized in a 1:1 ratio to receive double-blinded treatment (DBT) with either ocrelizumab or placebo followed by an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), \& follow-up 2 (FU2).

DBT
Participant flow — DBT
MilestoneOcrelizumabPlacebo
Started505508
Safety analysis set (sas)506506
Completed321273
Not completed184235
Withdrew: Ongoing in dbt108109
Withdrew: Adverse event86
Withdrew: Death119
Withdrew: Lack of efficacy12
Withdrew: Lost to follow-up35
Withdrew: Reason not specified01
Withdrew: Physician decision05
Withdrew: Protocol violation01
Withdrew: Switch to commercial ocrelizumab14
Withdrew: Withdrawal by subject3555
Withdrew: Discontinued and entered pdp ocr treatment phase931
Withdrew: Discontinued and entered fu1 phase87
PDP OCR Treatment Phase
Participant flow — PDP OCR Treatment Phase
MilestoneOcrelizumabPlacebo
Started931
Completed00
Not completed931
Withdrew: Ongoing in pdp ocr phase626
Withdrew: Discontinued and entered fu201
Withdrew: Death10
Withdrew: Withdrawal by subject14
Withdrew: Physician decision10
FU1 Phase
Participant flow — FU1 Phase
MilestoneOcrelizumabPlacebo
Started87
Completed21
Not completed66
Withdrew: Ongoing in fu1 phase22
Withdrew: Death01
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject33
OCR OLE Phase
Participant flow — OCR OLE Phase
MilestoneOcrelizumabPlacebo
Started321273
Completed00
Not completed321273
Withdrew: Ongoing in ole phase309261
Withdrew: Adverse event11
Withdrew: Death34
Withdrew: Lost to follow-up01
Withdrew: Withdrawal by subject65
Withdrew: Discontinued and entered fu221
FU2 Phase
Participant flow — FU2 Phase
MilestoneOcrelizumabPlacebo
Started43
Completed01
Not completed42
Withdrew: Ongoing in fu2 phase22
Withdrew: Death10
Withdrew: Lost to follow-up10

Outcome measures

PrimaryTime to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS

Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS
weeksOcrelizumabPlacebo
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS204.9 (141.1 to NA)133.6 (121.9 to 168.1)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = 0.0007 · Hazard ratio (hr): 0.70 · 95% CI 0.57 to 0.86
PrimaryTime to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set

Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in EDSS score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set
weeksOcrelizumabPlacebo
Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis SetNA (NA to NA)124.9 (103.3 to NA)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = <.0001 · Hazard ratio (hr): 0.45 · 95% CI 0.31 to 0.64
SecondaryTime to 12-week CDP in 9-HPT

12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to 12-week CDP in 9-HPT
weeksOcrelizumabPlacebo
Time to 12-week CDP in 9-HPT204.9 (NA to NA)203.3 (168.1 to NA)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = 0.0002 · Hazard ratio (hr): 0.59 · 95% CI 0.44 to 0.78
SecondaryTime to 12-week CDP in EDSS

12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated \& then scored as a functional system scores (FSS), \& ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, \& ambulation score that is rated from 0 to 16. These ratings along with observations \& assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to 12-week CDP in EDSS
weeksOcrelizumabPlacebo
Time to 12-week CDP in EDSSNA (NA to NA)155.7 (146.0 to NA)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = 0.0013 · Hazard ratio (hr): 0.67 · 95% CI 0.53 to 0.86
SecondaryTime to 24-week CDP in 9-HPT

24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to 24-week CDP in 9-HPT
weeksOcrelizumabPlacebo
Time to 24-week CDP in 9-HPT180.1 (180.1 to NA)203.3 (168.1 to NA)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = <.0001 · Hazard ratio (hr): 0.52 · 95% CI 0.38 to 0.71
SecondaryTime to 24-week CDP in EDSS

24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.

Time frame:
Up to approximately 243 weeks
Reported as:
Median · weeks
Time to 24-week CDP in EDSS
weeksOcrelizumabPlacebo
Time to 24-week CDP in EDSSNA (NA to NA)155.7 (146.0 to NA)
Statistical analysis
  • Ocrelizumab vs Placebo · Log Rank · p = 0.0018 · Hazard ratio (hr): 0.67 · 95% CI 0.52 to 0.86
SecondaryAnnual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions

Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change.

Time frame:
Up to approximately 120 weeks
Reported as:
Number · centimeter (cm) per year
Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions
centimeter (cm) per yearOcrelizumabPlacebo
Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions-0.016 (-0.021 to -0.010)0.021 (0.013 to 0.029)
Statistical analysis
  • Ocrelizumab vs Placebo · Wald Test · p = <.0001 · Difference in annual rates of change: -0.037 · 95% CI -0.046 to -0.028
SecondaryAnnual Rate of Percent Change From Week 24 in Total Brain Volume

Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change.

Time frame:
From Week 24 up to approximately 120 weeks
Reported as:
Number · percent change per year
Annual Rate of Percent Change From Week 24 in Total Brain Volume
percent change per yearOcrelizumabPlacebo
Annual Rate of Percent Change From Week 24 in Total Brain Volume-0.566 (-0.654 to -0.477)-0.564 (-0.660 to -0.468)
Statistical analysis
  • Ocrelizumab vs Placebo · Wald Test · p = 0.9711 · Difference in annual rates of change: -0.002 · 95% CI -0.091 to 0.087
SecondaryNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment.

Time frame:
From initiation of study drug up to approximately 10.5 years

Results for this outcome have not been posted.

SecondarySerum Concentration of Ocrelizumab
Time frame:
Up to approximately 10.5 years

Results for this outcome have not been posted.

SecondaryB-cell Levels in Blood
Time frame:
Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Reported as:
Mean · cells/microliters (cells/μL)
B-cell Levels in Blood
cells/microliters (cells/μL)OcrelizumabPlacebo
Baseline221.20 ± 122.80212.09 ± 117.06
Week 20.98 ± 7.78207.07 ± 114.54
Week 1214.57 ± 53.95252.58 ± 83.48
Week 249.31 ± 26.22206.19 ± 117.72
Week 3635.73 ± 50.79232.94 ± 156.34
Week 487.59 ± 22.66200.35 ± 108.76
Week 6036.08 ± 61.01217.64 ± 150.79
Week 727.55 ± 26.75196.81 ± 110.00
Week 8415.04 ± 30.10219.46 ± 135.10
Week 968.03 ± 26.25197.81 ± 112.76
Week 10827.66 ± 57.90205.44 ± 90.71
Week 1209.36 ± 42.94202.21 ± 126.00
Week 13213.93 ± 39.57200.75 ± 105.92
Week 1443.48 ± 8.38192.82 ± 80.97
Week 1564.50 ± 0.71215.00 ± 59.40
Week 1680.00 ± NA152.67 ± 94.65
Week 18036.00 ± NA—
Week 192—135.00 ± NA
Week 204259.00 ± NA—
Week 2280.00 ± NA—
SecondaryChange From Baseline in B-cell Levels
Time frame:
Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Reported as:
Mean · cells/μL
Change From Baseline in B-cell Levels
cells/μLOcrelizumabPlacebo
Change at Week 2-218.56 ± 121.25-3.18 ± 74.88
Change at Week 12-208.29 ± 124.709.33 ± 60.64
Change at Week 24-210.92 ± 118.65-2.12 ± 91.17
Change at Week 36-206.70 ± 101.74-9.65 ± 100.67
Change at Week 48-216.97 ± 118.30-10.11 ± 78.67
Change at Week 60-209.92 ± 109.68-7.19 ± 146.55
Change at Week 72-220.87 ± 122.14-7.43 ± 83.34
Change at Week 84-206.36 ± 98.52-19.54 ± 83.21
Change at Week 96-223.86 ± 124.29-9.29 ± 94.36
Change at Week 108-197.66 ± 122.00-44.65 ± 130.97
Change at Week 120-216.28 ± 126.33-1.99 ± 90.39
Change at Week 132-243.00 ± 144.23-18.23 ± 117.14
Change at Week 144-227.07 ± 106.36-24.94 ± 55.75
Change at Week 156-206.50 ± 161.93-60.00 ± 76.37
Change at Week 168-282.00 ± NA-127.67 ± 68.54
Change at Week 180-60.00 ± NA—
Change at Week 192—-104.00 ± NA
Change at Week 204-278.00 ± NA—
Change at Week 228-537.00 ± NA—
SecondaryPercentage of Participants With B-cell Counts ≤5 Cells/μL

Percentages have been rounded off.

Time frame:
Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Reported as:
Number · percentage of participants
Percentage of Participants With B-cell Counts ≤5 Cells/μL
percentage of participantsOcrelizumabPlacebo
Baseline0.80
Week 298.90.4
Week 1292.90
Week 2478.40
Week 3642.40
Week 4884.20.5
Week 6050.00
Week 7284.01.2
Week 8466.73.6
Week 9683.70
Week 10861.51.8
Week 12084.30.4
Week 13279.71.9
Week 14489.70
Week 1561000
Week 1681000
Week 1800—
Week 192—0
Week 2040—
Week 228100—
SecondaryPercentage of Participants With B-cell Counts ≤10 Cells/μL

Percentages have been rounded off.

Time frame:
Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Reported as:
Number · percentage of participants
Percentage of Participants With B-cell Counts ≤10 Cells/μL
percentage of participantsOcrelizumabPlacebo
Baseline1.00
Week 299.60.4
Week 1292.90
Week 2485.50
Week 3651.50
Week 4887.30.5
Week 6058.30
Week 7289.41.2
Week 8475.63.6
Week 9688.50.4
Week 10869.21.8
Week 12088.81.3
Week 13283.11.9
Week 14489.70
Week 1561000
Week 1681000
Week 1800—
Week 192—0
Week 2040—
Week 228100—
SecondaryNumber of Participants With ADAs to Ocrelizumab

Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result.

Time frame:
Baseline up to approximately 10.5 years

Results for this outcome have not been posted.

Adverse events

Collected over AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ocrelizumab16/506 (3.2%)65/506 (12.8%)257/506 (50.8%)
Placebo14/506 (2.8%)68/506 (13.4%)201/506 (39.7%)
Most frequent serious events
Showing 10 of 114
Most frequent serious events
EventOcrelizumabPlacebo
COVID-19 pneumoniaInfections and infestations13/5068/506
COVID-19Infections and infestations7/5061/506
PneumoniaInfections and infestations4/5063/506
Urinary tract infectionInfections and infestations4/5064/506
UrosepsisInfections and infestations3/5064/506
Myocardial infarctionCardiac disorders1/5063/506
Femoral neck fractureInjury, poisoning and procedural complications3/5062/506
Femur fractureInjury, poisoning and procedural complications0/5063/506
Multiple sclerosisNervous system disorders2/5063/506
Multiple sclerosis relapseNervous system disorders0/5063/506
Most frequent other events
Most frequent other events
EventOcrelizumabPlacebo
Infusion related reactionInjury, poisoning and procedural complications99/50621/506
COVID-19Infections and infestations75/50656/506
Urinary tract infectionInfections and infestations54/50659/506
HeadacheNervous system disorders48/50644/506
NasopharyngitisInfections and infestations37/50646/506
Upper respiratory tract infectionInfections and infestations30/50621/506
Back painMusculoskeletal and connective tissue disorders27/50625/506

Baseline characteristics

Full analysis set (FAS) included all randomized participants.

Age, Continuous
Age, Continuous(years)OcrelizumabPlaceboTotal
Mean47.7 ± 10.547.1 ± 10.647.4 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)OcrelizumabPlaceboTotal
Female290278568
Male215230445
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)OcrelizumabPlaceboTotal
Hispanic or Latino312253
Not Hispanic or Latino457476933
Unknown or Not Reported171027
Race (NIH/OMB)
Race (NIH/OMB)(Participants)OcrelizumabPlaceboTotal
American Indian or Alaska Native181432
Asian022
Native Hawaiian or Other Pacific Islander202
Black or African American213
White464480944
More than one race448
Unknown or Not Reported15722
07

Study locations

155 sites
  • Georgetown University Medical Center
    Washington D.C., District of Columbia 20007, United States
  • MS and Neuromuscular Center of Excellence
    Clearwater, Florida 33761, United States
  • Neurological Services of Orlando
    Orlando, Florida 32806, United States
  • Vero Neurology
    Vero Beach, Florida 32960, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
  • The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company
    Columbus, Ohio 43235-5422, United States
  • Columbus Neuroscience
    Westerville, Ohio 43082-6910, United States
  • Albert Einstein Medical Center
    Philadelphia, Pennsylvania 19141, United States
  • Brain and Mind Research Institute
    Camperdown, New South Wales 2050, Australia
  • Austin Hospital
    Heidelberg, Victoria 3084, Australia
  • Royal Melbourne Hospital
    Parkville, Victoria 3050, Australia
  • UZ Antwerpen
    Edegem, Antwerpen 2650, Belgium
  • Cliniques Universitaires St-Luc
    Brussels, 1200, Belgium
  • MS & Neurologisch Revalidatie Centrum
    Overpelt, 3900, Belgium
  • Military Medical Academy HBAT
    Pleven, 5800, Bulgaria
  • Multiprofile Hospital For Active Treatment Avis Medica
    Pleven, 5800, Bulgaria
  • Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD
    Sofia, 1113, Bulgaria
  • University of Alberta
    Edmonton, Alberta T6G 2G3, Canada
  • Dalhousie Multiple Sclerosis Research Unit
    Halifax, Nova Scotia B3H 4K4, Canada
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
  • Recherche Sepmus Inc.
    Greenfield Park, Quebec J4V 2J2, Canada
  • Instituto Neurologico de Colombia INDEC
    Medellín, Antioquia 50012, Colombia
  • Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
    Bogotá, 111321, Colombia
  • General Hospital Varazdin
    Varaždin, 42000, Croatia
  • Clinical Hospital Sestre Milosrdnice
    Zagreb, 10000, Croatia
  • University Hospital Center Zagreb
    Zagreb, 10000, Croatia
  • CHU de Bordeaux - Hôpital Pellegrin
    Bordeaux, 33076, France
  • Centre Hospitalier Universitaire de Clermont Ferrand
    Clermont-Ferrand, 63003, France
  • CHRU Nancy
    Nancy, 54035, France
  • Hopital Guillaume Et Rene Laennec
    Nantes, 44805, France
  • CHU de Nimes - Hopital Universitaire Caremeau
    Nîmes, 30900, France
  • Hopital Civil
    Strasbourg, 67098, France
  • Pineo Medical Ecosystem LTD
    Tbilisi, 0114, Georgia
  • The First University Clinic of Tbilisi State Medical University
    Tbilisi, 0141, Georgia
  • Khechinashvili University Hospital
    Tbilisi, 179, Georgia
  • AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2
    Naples, Campania 80138, Italy
  • Fondazione PTV Policlinico Tor Vergata
    Rome, Lazio 00133, Italy
  • Azienda Ospedaliera Sant'andrea
    Rome, Lazio 00189, Italy
  • IRCCS AOM Azienda Ospedaliera Metropolitana
    Genoa, Liguria 16132, Italy
  • Ospedale San Raffaele S.r.l. - PPDS
    Milan, Lombardy 20132, Italy
  • Fondazione Istituto Neurologico Mondino IRCCS
    Pavia, Lombardy 27100, Italy
  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
    Orbassano, Piedmont 10043, Italy
  • Fondazione Istituto G. Giglio di Cefalu
    Cefalù, Sicily 90015, Italy
  • Hotel Dieu de France
    Achrafieh Beirut, 000000, Lebanon
  • Saint George University Medical Hospital
    El Achrafiyé, DUMMY_VALUE, Lebanon
  • Grupo Medico Camino
    Mexico City, Mexico CITY (federal District) 03310, Mexico
  • Neurociencias Estudios Clinicos S.C.
    Culiacán, Sinaloa 80020, Mexico
  • Hospital Angeles Chihuahua
    Chihuahua City, 31238, Mexico
  • Unidad de Investigacion en Salud de Chihuahua
    Mexico City, 14050, Mexico
  • Clinical Research Institute
    Tlalnepantla, 54055, Mexico
  • CHU Mohammed VI
    Marrakesh, 40080, Morocco
  • Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
    Rabat, 10100, Morocco
  • New Zealand Clinical Research - Christchurch
    Christchurch, 8011, New Zealand
  • Dunedin Hospital
    Dunedin, New Zealand
  • Neurocentrum Bydgoszcz sp z o.o
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
  • Przychodnia EuroMediCare
    Wroclaw, Lower Silesian Voivodeship 50-220, Poland
  • Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak
    Lublin, Lublin Voivodeship 20-410, Poland
  • Centrum Medyczne Medyk
    Rzeszów, Podkarpackie Voivodeship 35-055, Poland
  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
    Rybnik, Silesian Voivodeship 44-200, Poland
  • Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a
    Bia?ystok, 15-276, Poland
  • Copernicus Podmiot Leczniczy Sp z o o
    Gda?sk, 80-803, Poland
  • Mazowieckie Centrum Badan Klinicznych
    Grodzisk Mazowiecki, 05-825, Poland
  • MA-LEK Clinical Sp. Z o.o.
    Katowice, 40-571, Poland
  • Novo-Med Zielinski i wsp SpJ
    Katowice, 40-584, Poland
  • NEURO-MEDIC Sp. z o. o.
    Katowice, 40-686, Poland
  • Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo
    Katowice, 40-752, Poland
  • Szpital Uniwersytecki w Krakowie
    Krakow, 31-503, Poland
  • Centrum Neurologii Krzysztof Selmaj
    Lodz, 90-324, Poland
  • Galen Clinic
    Lublin, 20-064, Poland
  • Wojewodzki Szpital Specjalistyczny
    Olsztyn, 10-561, Poland
  • Med-Polonia Sp. z o.o.
    Poznan, 60-693, Poland
  • EUROMEDIS Sp z o o
    Szczecin, 70-215, Poland
  • Centrum Medyczne NeuroProtect Zablocinska 10
    Warsaw, 01-684, Poland
  • RESMEDICA Spolka z o.o.
    Kielce, Świętokrzyskie Voivodeship 25-726, Poland
  • ULS de Loures-Odivelas, EPE - Hospital de Loures
    Loures, Lisbon District 2674-514, Portugal
  • Hospital Garcia de Orta
    Almada, 2805-267, Portugal
  • Hospital de Braga
    Braga, 4710-243, Portugal
  • Hospital de Santo Antonio
    Porto, 4099-001, Portugal
  • Campus Neurologico Senior
    Torres Vedras, 2560-280, Portugal
  • Spitalul Judetean de Urgenta Deva
    Deva, Hunedoara County 330084, Romania
  • SC Clubul Sanatatii SRL
    Campulung Muscel, 115100, Romania
  • Cai Ferate Clinical Hospital
    Constanța, 900123, Romania
  • Targu Mures Clinical Emergency County Hospital
    Târgu Mure?, 540136, Romania
  • Krasnoyarsk State Medical Academy
    Krasnoyarsk, Krasnoyarsk Krai 660022, Russia
  • City Clinical Hospital a n Buyanov V M
    Moscow, Moscow Oblast 115516, Russia
  • City Clinical Hospital #24
    Moscow, Moscow Oblast 127015, Russia
  • Moscow Regional Research Clinical Institute Na Mfvladimirskiy
    Moscow, Moscow Oblast 129110, Russia
  • Research Center of Neurology of RAMS
    Moskva, Moscow Oblast 125367, Russia
  • Neftyanik Medical and Sanitary Unit
    Tumen, Moscow Oblast 625000, Russia
  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
    Nizhny Novgorod, Niznij Novgorod 603126, Russia
  • MEDIS Limited Liability Company
    Nizhny Novgorod, Niznij Novgorod 603137, Russia
  • SBHI of Nizhny Novgorod region City Clinical Hospital #3
    Nizhny Novgorod, Niznij Novgorod 603155, Russia
  • National Center of Socially Significant Diseases
    Saint Petersburg, Sankt-Peterburg 197110, Russia
  • City Hospital #40 of Kurortniy Administrative District
    Saint Petersburg, Sankt-Peterburg 197706, Russia
  • City Clinical Hospital #4
    Saransk, Saratov Oblast 430032, Russia
  • Sverdlovsk Regional Clinical Hospital 1
    Yekaterinburg, Sverdlovsk Oblast 620102, Russia
  • Vertebronevrologiya LLC
    Kazan', Tatarstan Republic 420043, Russia
  • Ulyanovsk Regional Clinical Hospital
    Ulyanovsk, Ulyanovsk Oblast 432063, Russia
  • Belyayev Clinical Hospital of the Kuzbass
    Kemerovo, 650066, Russia
  • Kirov State Medical Academy
    Kirov, 610027, Russia

Showing the first 100 of 155 sites across 23 countries.

08

References and documents

Publications

  • Giovannoni G, Airas L, Bove R, Cutter GR, Czarnecki M, Drulovic J, Hobart J, Kuhle J, Montalban X, Selmaj KW, Tur C, Wolinsky JS, Baldinotti A, Bonati U, Craveiro L, Giacobino C, Manfrini M, Schneble HM, Stevenson P, Wang Q, Yang K, Oh J; ORATORIO-HAND study group. Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study. Lancet. 2026 May 30;407(10544):2195-2207. doi: 10.1016/S0140-6736(26)00617-3. PubMed 42208561 ↗

Study documents

  • Study protocol · Jul 4, 2024
  • Statistical analysis plan · Mar 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

09

Registry details

Key details

Study ID
NCT04035005
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jul 29, 2019
Start date
Aug 12, 2019
Primary completion
Jan 15, 2025
Completion
Jan 19, 2028 (estimated)
Results posted
Feb 23, 2026
Last update
Feb 23, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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