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

NCT06847724

Active Not RecruitingPhase 3

Sponsor: Sandoz

Conditions: Relapsing Multiple Sclerosis

Interventions: CYB704, Ocrevus-EU, Ocrevus-US

Countries: United States, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, North Macedonia, Poland, Serbia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (41)
  • Maitland, Florida, United States
  • Ormond Beach, Florida, United States
  • Banja Luka, Bosnia and Herzegovina
  • Bihać, Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Varaždin, Croatia
  • Zagreb, Croatia
  • Rustavi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • Shtip, North Macedonia
  • Skopje, North Macedonia
  • Bydgoszcz, Poland
  • Katowice, Poland
  • Katowice, Poland
  • + 11 more on CT.gov