RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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].

Quick Facts

Study Start:2025-06-10
Study Completion:2029-10-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06847724

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of RMS (relapsing remitting multiple sclerosis (MS) or active secondary progressive MS)
  2. * Evidence of recent disease activity as defined in study protocol
  3. * Expanded Disability Status scale score of 0 to 5.5 (inclusive) at screening
  4. * Neurological stability (no new signs or symptoms referable to Central Nervous System (CNS) within 30 days before both screening and first study treatment
  1. * Diagnosis of primary progressive MS
  2. * Disease duration of more than 10 years in participants with an Expanded Disability Status Scale (EDSS) ≤2.0 at screening
  3. * Inability to complete an MRI or contraindication to gadolinium administration
  4. * History of allergic or anaphylactic reactions to ocrelizumab or one of the premedications (methylprednisolone or equivalent corticosteroid, antihistamine, antipyretic)
  5. * Pregnant participants
  6. * Current or history of medical conditions as outlined in the study protocol
  7. * Prohibited medications (current and history) as outlined in the study protocol
  8. * Abnormal laboratory blood values as outlined in the study protocol

Contacts and Locations

Study Contact

Clinical Disclosure Representative
CONTACT
+49 8024 / 908 0
sandoz.disclosure@sandoz.net

Study Locations (Sites)

Sandoz Investigational Site
Maitland, Florida, 32751
United States
Sandoz Investigational Site
Ormond Beach, Florida, 32174
United States

Collaborators and Investigators

Sponsor: Sandoz

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-10
Study Completion Date2029-10-14

Study Record Updates

Study Start Date2025-06-10
Study Completion Date2029-10-14

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis