NCT06847724

Brief Summary

The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are:

  • Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)?
  • Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will:
  • Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU)
  • Visit the clinic for at least 15 treatment visits, checkups and tests
  • Will undergo regular magnetic resonance imaging (MRI) examinations

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P25-P50 for phase_3

Timeline
42mo left

Started Jun 2025

Typical duration for phase_3

Geographic Reach
8 countries

41 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jun 2025Oct 2029

First Submitted

Initial submission to the registry

February 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2029

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

February 19, 2025

Last Update Submit

April 24, 2026

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Area under the concentration time curve

    Demonstrate similar PK between Ocrevus and CYB704

    Week 1 - 3, week 3 - 25

Secondary Outcomes (10)

  • Area under the plasma concentration versus time curve (AUC)

    Week 1 - 25

  • Peak Plasma Concentration (Cmax)

    Day 1 and Day 15

  • CD19+ B-cell count

    Up to 48 weeks

  • Number of new T1 GdE lesions on brain MRI scans

    Up to 48 weeks

  • Number of T1 GdE lesions

    Up to 48 weeks

  • +5 more secondary outcomes

Study Arms (2)

CYB704

EXPERIMENTAL

Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.

Biological: CYB704

Ocrevus-US/Ocrevus-EU

ACTIVE COMPARATOR

Drug: Ocrevus-US/Ocrevus-EU Patients will be dosed 300 mg on day 1 and day 15 with Ocrevus-US. Subsequent dose of 600 mg Ocrevus-EU will be administered 24 weeks after the initial dose.

Biological: Ocrevus-EUBiological: Ocrevus-US

Interventions

CYB704BIOLOGICAL

Intravenous Infusion

Also known as: Ocrelizumab
CYB704
Ocrevus-EUBIOLOGICAL

Intravenous Infusion

Also known as: Ocrelizumab
Ocrevus-US/Ocrevus-EU
Ocrevus-USBIOLOGICAL

Intravenous Infusion

Also known as: Ocrelizumab
Ocrevus-US/Ocrevus-EU

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or active secondary progressive MS)
  • Evidence of recent disease activity as defined in study protocol
  • Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
  • Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment

You may not qualify if:

  • Diagnosis of primary progressive MS
  • Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
  • Inability to complete an MRI or contraindication to gadolinium administration
  • History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
  • Pregnant participants
  • Current or history of medical conditions as outlined in the study protocol
  • Prohibited medications (current and history) as outlined in the study protocol
  • Abnormal laboratory blood values as outlined in the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Sandoz Investigational Site

Maitland, Florida, 32751, United States

RECRUITING

Sandoz Investigational Site

Ormond Beach, Florida, 32174, United States

RECRUITING

Sandoz Investigational Site

Banja Luka, Bosnia and Herzegovina

RECRUITING

Sandoz Investigational Site

Bihać, Bosnia and Herzegovina

RECRUITING

Sandoz Investigational Site 2

Sarajevo, Bosnia and Herzegovina

RECRUITING

Sandoz Investigational Site

Sarajevo, Bosnia and Herzegovina

RECRUITING

Sandoz Investigational Site

Pleven, Bulgaria

RECRUITING

Sandoz Investigational Site 2

Plovdiv, Bulgaria

RECRUITING

Sandoz Investigational Site

Plovdiv, Bulgaria

RECRUITING

Sandoz Investigational Site 2

Sofia, Bulgaria

RECRUITING

Sandoz Investigational Site 3

Sofia, Bulgaria

RECRUITING

Sandoz Investigational Site 4

Sofia, Bulgaria

RECRUITING

Sandoz Investigational Site 5

Sofia, Bulgaria

RECRUITING

Sandoz Investigational Site

Sofia, Bulgaria

RECRUITING

Sandoz Investigational Site

Varaždin, Croatia

RECRUITING

Sandoz Investigational Site

Zagreb, Croatia

RECRUITING

Sandoz Investigational Site

Rustavi, Georgia

RECRUITING

Sandoz Investigational Site 2

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 3

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 4

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 5

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 6

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 7

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site 8

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site

Tbilisi, Georgia

RECRUITING

Sandoz Investigational Site

Shtip, North Macedonia

RECRUITING

Sandoz Investigational Site

Skopje, North Macedonia

RECRUITING

Sandoz Investigational Site

Bydgoszcz, Poland

RECRUITING

Sandoz Investigational Site 2

Katowice, Poland

RECRUITING

Sandoz Investigational Site

Katowice, Poland

RECRUITING

Sandoz Investigational Site

Lodz, Poland

RECRUITING

Sandoz Investigational Site 2

Lublin, Poland

RECRUITING

Sandoz Investigational Site

Lublin, Poland

RECRUITING

Sandoz Investigational Site

Nowa Sól, Poland

RECRUITING

Sandoz Investigational Site 2

Poznan, Poland

RECRUITING

Sandoz Investigational Site

Poznan, Poland

RECRUITING

Sandoz Investigational Site

Szczecin, Poland

RECRUITING

Sandoz Investigational Site

Warsaw, Poland

RECRUITING

Sandoz Investigational Site

Zabrze, Poland

RECRUITING

Sandoz Investigational Site

Belgrade, Serbia

RECRUITING

Sandoz Investigational Site

Niš, Serbia

RECRUITING

MeSH Terms

Interventions

ocrelizumab

Central Study Contacts

Clinical Disclosure Representative

CONTACT

+49 8024 / 908 0sandoz.disclosure@sandoz.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 26, 2025

Study Start

June 10, 2025

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

October 14, 2029

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)CR(2)NO(2)BO(4)BU(8)SE(2)PL(12)GE(9)