A Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of RPH-035 and Ocrevus® in Patients With Relapsing-remitting or Secondary Progressive Multiple Sclerosis With Exacerbations

NCT07597668 | Active Not Recruiting Phase 1

• 1 other identifier: CL04785171
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 23

Brief Summary

The study goal is to establish the equivalence of pharmacokinetic (PK) properties, as well as the comparability of safety, immunogenicity (IG) and pharmacodynamics (PD) of the drug product RPH-035 (R-Pharm JSC, Russia) in comparison with the drug product Ocrevus® (F. Hoffmann-La Roche Ltd., Switzerland) when used in patients with multiple sclerosis (MS)

Conditions

Multiple Sclerosis

Keywords

RPH-035; Ocrelizumab; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The area under the concentration-time pharmacokinetic curve (AUC (14-169 days)) of ocrelizumab

  The area under the concentration-time pharmacokinetic curve of ocrelizumab after the second (single) administration, truncated at Day 169 (AUC (14-169 days))

  Day 14 to Day 169

Secondary Outcomes (14)

• The area under the concentration-time pharmacokinetic curve (AUC (0-14 days)) of ocrelizumab

  Up to Day 14

• Maximum serum concentration of ocrelizumab after the first administration (Cmax (0-14 days))

  Up to Day 14

• Maximum serum concentration of ocrelizumab after the second administration (Cmax (14-169 days))

  Day 14 to Day 169

• Percentage of patients with adverse reactions (ARs) of any severity

  Up to Day 337

• Percentage of patients with adverse events (AEs) of any severity

  Up to Day 337

Other Outcomes (32)

• Time to reach the maximum ocrelizumab concentration in serum after the first administration (Tmax (0-14 days))

  Up to Day 14

• Elimination half-life of ocrelizumab after the first administration (T1/2 (0-14 days))

  Up to Day 14

• Volume of distribution of ocrelizumab after the first administration (Vd (0-14 days))

  Up to Day 14

Study Arms (2)

RPH-035

EXPERIMENTAL

During the Main Period, the patients receive their first infusion of ocrelizumab (RPH-035) at a dose of 300 mg, followed by another 300 mg of the drug product after 2 weeks. The duration of ocrelizumab administration is 2.5 hours ± 15 minutes. The third infusion at a dose of 600 mg is administered 6 months after the first infusion of the initial dose During the After-Therapy Period, patients will receive an IV infusion of 600 mg of ocrelizumab (RPH-035) at weeks 49, 73, and 97 Premedication is mandatory and is carried out according to the following scheme: * methylprednisolone at a dose of 100 mg (or dexamethasone at a dose of 18.8 mg, or an equivalent drug product) intravenously 30 ± 10 minutes before the start of each infusion * antihistamine drug (e.g., diphenhydramine, suprastin, or an equivalent drug product) 30-60 minutes before the start of each infusion * antipyretic drug (e.g., paracetamol) 30-60 minutes before the start of each infusion

Drug: RPH-035

Ocrevus®

ACTIVE COMPARATOR

During the Main Period, the patients receive their first infusion of ocrelizumab (Ocrevus®) at a dose of 300 mg, followed by another 300 mg of the drug product after 2 weeks. The duration of ocrelizumab administration is 2.5 hours ± 15 minutes. The third infusion at a dose of 600 mg is administered 6 months after the first infusion of the initial dose Premedication is mandatory and is carried out according to the following scheme: * methylprednisolone at a dose of 100 mg (or dexamethasone at a dose of 18.8 mg, or an equivalent drug product) intravenously 30 ± 10 minutes before the start of each infusion * antihistamine drug (e.g., diphenhydramine, suprastin, or an equivalent drug product) 30-60 minutes before the start of each infusion * antipyretic drug (e.g., paracetamol) 30-60 minutes before the start of each infusion

Drug: Ocrevus®

Interventions

RPH-035 DRUG

300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL

Also known as: ocrelizumab, L04785

RPH-035

Ocrevus® DRUG

300 mg/10 mL (30 mg/mL) concentrate for solution for infusions in a single-dose vial For the 1st and 2nd infusions, 300 mg (10 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL. For the 3rd infusion, 600 mg (20 mL) of ocrelizumab is diluted in 0.9% sodium chloride to a final concentration of approximately 1.2 mg/mL

Also known as: ocrelizumab

Ocrevus®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of the voluntarily signed and dated patient Informed Consent (IC) form for participation in this study
• Multiple sclerosis with exacerbations (relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) with exacerbations) according to the McDonald diagnostic criteria as revised in 2017, with symptoms lasting at least 1 year before signing the IC form
• The patient's medical history includes the use of ≤ 3 prior multiple sclerosis disease modifying drugs (DMT)
• The patient has one of the following signs of disease activity:
• ≥ 2 documented disease exacerbations in the previous 24 months before the IC signing date
• ≥ 1 documented disease exacerbation in the previous 12 months before the IC signing date
• documented exacerbation in the previous 24 months before the IC signing date and ≥ 1 documented brain lesion on the contrast-enhanced Magnetic Resonance Imaging (MRI) scan in the previous 6 months before the IC signing date
• Expanded Disability Status Scale (EDSS) index is 0-5.5 points inclusively on screening
• No Multiple sclerosis (MS) exacerbations within 30 days before the IC signing date and throughout the entire screening examination
• Ability, in the Investigator's opinion, to comply with the Protocol procedures and requirements
• Negative pregnancy test for female participants with preserved reproductive potential
• Consent of the patient with preserved reproductive potential to abstain from heterosexual contacts or to use reliable contraceptive methods, starting from the moment of the IC form signing, throughout the entire treatment period within the study, as well as for 12 months after the last ocrelizumab administration. Female participants are considered infertile if definitive amenorrhea was determined (from patient's words) retrospectively after 12 months of natural amenorrhea, i.e amenorrhea with an appropriate clinical status, such as a suitable age (between 45 and 55 years )

You may not qualify if:

• Medical history of hypersensitivity to monoclonal antibody drugs or to any component of the investigational medicinal products
• Prior therapy with ocrelizumab
• Primary progressive multiple sclerosis or SPMS without exacerbations
• Contraindications for MRI, including intolerance to Gd-containing contrast agents and claustrophobia
• Medical history of other neurological diseases (excluding migraines) or first diagnosed on screening, including but not limited to the following:
• ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or spinal cord ischemia
• malignant and benign central nervous system (CNS) tumours (meningiomas, gliomas, etc.) requiring surgical intervention
• potential metabolic causes of myelopathy, identified from the medical history or in patient words (untreated vitamin B12 deficiency, etc.)
• infectious myelopathy (syphilis, Lyme disease, human T-lymphotropic virus 1 \[HTLV-1\], herpes zoster)
• hereditary progressive CNS degenerative disorder, MELAS (mitochondrial myopathy, encephalopathy, lactic acidosis, stroke)
• neuromyelitis optical spectrum disorders
• progressive multifocal leukoencephalopathy
• Systemic autoimmune disease (lupus, rheumatoid arthritis, antiphospholipid antibody syndrome, Sjorgen's syndrome, Behcet's syndrome)
• Sarcoidosis
• Medical history of severe, clinically significant brain or spinal cord injury (brain contusion, spinal cord compression)

Sponsors & Collaborators

• R-Pharm: lead

Study Sites (23)

State Autonomous Healthcare Institution Regional Clinical Hospital No. 3

Chelyabinsk, 454021, Russia

Location

Kazan State Medical Academy, branch of the Federal State Budgetary Educational Institution of Additional Professional Education Russian Medical Academy of Continuing Professional Education

Kazan', 420061, Russia

Location

State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"

Kazan', 420101, Russia

Location

Kirov Regional State Clinical Budgetary Healthcare Institution "Center for Cardiology and Neurology"

Kirov, 610007, Russia

Location

Limited Liability Company DOCKBRAIN

Krasnodar, 350049, Russia

Location

Federal State Budgetary Institution Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency

Krasnoyarsk, 660037, Russia

Location

Federal State Budgetary Scientific Institution "Russian Center for Neurology and Neurosciences"

Moscow, 125367, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "City Clinical Hospital No. 24 of the Moscow Health Department"

Moscow, 127015, Russia

Location

Research Lab LLC

Moscow, 127521, Russia

Location

State Budgetary Healthcare Institution of the Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"

Nizhny Novgorod, 603126, Russia

Location

MEDIS Limited Liability Company

Nizhny Novgorod, 603137, Russia

Location

Federal State Budgetary Healthcare Institution "Siberian District Medical Center of the Federal Medical and Biological Agency"

Novosibirsk, 630007, Russia

Location

State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

Novosibirsk, 630087, Russia

Location

State Budgetary Healthcare Institution of the Perm Region "Perm Regional Clinical Hospital of the Order of the Badge of Honor"

Perm, 614045, Russia

Location

Rostov Regional Clinical Hospital, State Budgetary Institution of the Rostov Region

Rostov-on-Don, 344015, Russia

Location

LLC "Center for Diagnostics and Rehabilitation "PRAKSIMED"

Saint Petersburg, 194223, Russia

Location

State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"

Saint Petersburg, 197110, Russia

Location

State Budgetary Healthcare Institution of the Republic of Mordovia "Republican Clinical Hospital No. 4"

Saransk, 430032, Russia

Location

Smolensk Regional Clinical Hospital, Regional State Budgetary Healthcare Institution

Smolensk, 214018, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation

Tomsk, 634050, Russia

Location

Joint Stock Company "Medical and Sanitary Unit "Neftyanik"

Tyumen, 625048, Russia

Location

Ulyanovsk Regional Clinical Hospital, a public health institution

Ulyanovsk, 432017, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Mikhail Samsonov

  R-Pharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical study is a double-blind study by design. Neither the investigator nor the patient will know which drug product (RPH-035 or Ocrevus®) is administered to the patient until week 49 of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 19, 2026
• Study Start: April 16, 2025
• Primary Completion: January 12, 2026
• Study Completion (Estimated): December 20, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

RU (23)