A Phase 3 interventional study of BCD-281 and Ocrelizumab in Relapsing-remitting Multiple Sclerosis (RRMS), sponsored by Biocad. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Biocad · Phase 3, Interventional, and Treatment
The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.
The study includes the following periods:
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 292 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Biocad is the lead sponsor of 94 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Documentary evidence of the following at the time of signing the ICF:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
Biological: BCD-281
Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.
Biological: Ocrelizumab
anti-CD20 monoclonal antibody
anti-CD20 monoclonal antibody
Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24.
The total number of T1 Gd+ lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 12, 16, 20 and 24.
Time frame: up to Week 24
Annualized relapse rate (ARR).
ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.
Time frame: up to Week 100
Time to first relapse.
Time frame: up to Week 100
Proportion of subjects without confirmed relapses.
Time frame: up to Week 100
Total number of T1 Gd+ lesions at Weeks 48, 72, 100.
Time frame: up to Week 100
Total number of new or enlarged T2 lesions.
Time frame: up to Week 100
Proportion of subjects without contrast-enhancing lesions.
Time frame: up to Week 100
Proportion of subjects without new or enlarged T2 lesions.
Time frame: up to Week 100
Total number of new hypointense T1 lesions.
Time frame: up to Week 100
Change in the volume of hypointense T1 lesions.
Time frame: up to Week 100
Change in the volume of T2 lesions.
Time frame: up to Week 100
Combined unique active (CUA).
The total number of new T1 Gd+ lesions and new or enlarging T2 lesions, without double counting
Time frame: up to Week 100
Changes over time in the neurologic deficit according to the Expanded Disability Status Scale (EDSS).
Changes in the neurologic deficit according to EEDSS to measure disability and disease progression (from 0 to 10). An increase in the EDSS score signifies worsening disability.
Time frame: up to Week 100
Changes over time in Timed 25-Foot (7.62 meters) Walk Test performance.
Time frame: up to Week 100
Changes over time in 9-Hole Peg Test (9HPT) performance.
Time frame: up to Week 100
Changes over time in Symbol Digit Modalities Test (SDMT) performance.
Time frame: up to Week 100
Change in quality of life using SF-36 questionnaire (36-Item Short Form Health Survey)
Change in the quality of life parameters using a SF-36 questionnaire. SF-36 (Short Form-36) questionnaire includes a total of 36 questions. Higher scores (0-100) mean better health.
Time frame: up to Week 100
Change in quality of life using EQ-5D questionnaire (EuroQol Five Dimensions)
A positive change in the Index score or a higher score generally means improvement in health. A negative change in the Index or a lower score means deterioration.
Time frame: up to Week 100
Proportion of subjects with confirmed disability progression (CDP).
Time frame: up to Week 100
Proportion of subjects with confirmed disability worsening (CDW).
Time frame: up to Week 100
The proportion of subjects with confirmed overall disability worsening.
Time frame: up to Week 100
Proportion of patients with adverse reactions
Time frame: up to Week 100
Proportion of patients with serious adverse reactions
Time frame: up to Week 100
AUC 168-336.
Area under the drug concentration-time curve for the time interval from the measurable concentration on Day 169 to the measurable concentration on Day 337 (before the fourth administration of the investigational products).
Time frame: up to Week 100
Cmax.
Maximum observed drug concentration.
Time frame: up to Week 100
Tmax.
Time to maximum plasma concentration.
Time frame: up to Week 100
T1/2.
Terminal Elimination Half-life (T1/2) of IP.
Time frame: up to Week 100
Kel.
The elimination rate constant.
Time frame: up to Week 100
Ceoi.
Time frame: up to Week 100
Ctrough.
Trough Concentration (Ctrough) of IP.
Time frame: up to Week 100
Pharmacodynamic endpoints.
PD will be evaluated based on the determination of CD19+ B-cell levels in subjects' blood.
Time frame: up to Week 100
Proportion of subjects with binding antibodies (BAbs).
Time frame: up to Week 100
Proportion of subjects with neutralizing antibodies (NAbs).
Time frame: up to Week 100
Time to BAb/NAb positivity.
Time frame: up to Week 100
Plan to share: No
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Multiple Sclerosis, Relapsing-Remitting →