Fact CheckerSign in

NCT06847724Active, not recruitingPhase 3

Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis

A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS) [STRIVE-MS].

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
183 (actual)
First submitted
19 Feb 2025
Start date
10 Jun 2025
Primary completion date
Nov 2026
Lead sponsor
Sandoz
NCT number
NCT06847724
EU CT number
2024-512319-40-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 183
  • From 10 Jun 2025 to the primary completion date, Nov 2026
  • 41 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prohibited medications (current and history) as outlined in the study protocol

Other illness

  • Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
  • History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
  • Current or history of medical conditions as outlined in the study protocol

Lab values

  • Abnormal laboratory blood values as outlined in the study protocol

Other

  • Diagnosis of primary progressive MS
  • Inability to complete an MRI or contraindication to gadolinium administration
  • Pregnant participants

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical Center Academica 2008 EOOD
Coordinator of this site? Confirm its status
PlevenBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOOD
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Coordinator of this site? Confirm its status
PlovdivBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
Medical Center Medica 2005 EOOD
Coordinator of this site? Confirm its status
SofiaBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Diagnostics And Consultation Center Convex Ltd.
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
Acibadem City Clinic Tokuda University Hospital EAD
Coordinator of this site? Confirm its status
SofiyaBulgariaActive, not recruiting
-
Coordinator of this site? Confirm its status
RustaviGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
-
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Opca Bolnica Varazdin
Coordinator of this site? Confirm its status
VarazdinCroatiaActive, not recruiting
University Hospital Centre Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaActive, not recruiting
-
Coordinator of this site? Confirm its status
ShtipNorth MacedoniaUnknown status
-
Coordinator of this site? Confirm its status
SkopjeNorth MacedoniaUnknown status
Neurocentrum Bydgoszcz sp. z o.o
Coordinator of this site? Confirm its status
BydgoszczPolandActive, not recruiting
MA-LEK Clinical Sp. z o.o.
Coordinator of this site? Confirm its status
KatowicePolandActive, not recruiting
NEURO-MEDIC Sp. z o. o.
Coordinator of this site? Confirm its status
KatowicePolandActive, not recruiting
Centrum Neurologii Krzysztof Selmaj
Coordinator of this site? Confirm its status
ŁódźPolandActive, not recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
Zanamed Medical Clinic Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
Nowa SolPolandActive, not recruiting
Ilkowski I Partnerzy sp.p. Lekarzy
Coordinator of this site? Confirm its status
PoznanPolandActive, not recruiting
Med Polonia Sp z o.o.
Coordinator of this site? Confirm its status
PoznanPolandActive, not recruiting
EUROMEDIS Sp z o o
Coordinator of this site? Confirm its status
SzczecinPolandActive, not recruiting
Centrum Medyczne NeuroProtect
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Coordinator of this site? Confirm its status
ZabrzePolandActive, not recruiting
-
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
-
Coordinator of this site? Confirm its status
NišSerbiaUnknown status
-
Coordinator of this site? Confirm its status
MaitlandUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Ormond BeachUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Banja LukaBosnia and HerzegovinaUnknown status
-
Coordinator of this site? Confirm its status
BihaćBosnia and HerzegovinaUnknown status
-
Coordinator of this site? Confirm its status
SarajevoBosnia and HerzegovinaUnknown status
-
Coordinator of this site? Confirm its status
SarajevoBosnia and HerzegovinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.