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2022-501622-37-00Active, not recruitingPhase 3

A Double-blind, Randomized, Active-controlled, Parallel-group, Phase 1/3 study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients with Relapsing-remitting Multiple Sclerosis.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Nov 2026

Next steps

Brief summary (registry, in English)

1. PK Group: To demonstrate PK comparability of CT-P53, EU-approved Ocrevus and US-licensed Ocrevus in patients with RRMS

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
333 (estimated)
First submitted
28 Apr 2023
Start date
16 Jan 2024
Lead sponsor
Celltrion Inc.
EU CT number
2022-501622-37-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 333
  • 49 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.

Other illness

  • Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.
  • Patient who has currently or history of any of medical conditions described in the study protocol.

Other

  • Patient diagnosed with primary or secondary progressive MS.
  • Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.
  • Patient unable to complete or has a contraindication to an MRI

Who the study is looking for

  • Patient is male or female aged between 18 years and 55 years (both inclusive)
  • Patient diagnosed as Multiple Sclerosis (MS) in accordance with the revised McDonald criteria (2017).
  • Patient has evidence of recent MS activity as defined in the study protocol.
  • Patient has neurological stability for ≥30 days.
  • Patient with 0 to 6.0 (both inclusive) on the EDSS score.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (49)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Multiprofile Hospital For Active Treatment Elin Pelin EOODElin PelinBulgariaActive, not recruiting
Medical Center Hera EOODMontanaBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.PanagyurishteBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment Avis Medika OODPlevenBulgariaActive, not recruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EADPlevenBulgariaActive, not recruiting
Alexandrovska University HospitalSofiaBulgariaActive, not recruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EADSofiaBulgariaActive, not recruiting
Medicinski Center Syrtuin Ltd.SofiaBulgariaActive, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EADSofiaBulgariaActive, not recruiting
Medical Center Hera EOODSofiyaBulgariaActive, not recruiting
Multiprofessional Hospital For Active Treatment Health 2012 OODSofiyaBulgariaActive, not recruiting
Sveta Marina Pharma EOODVarnaBulgariaActive, not recruiting
NEUROHK s r oChoceňCzechiaActive, not recruiting
doc. MUDr. Radomír Taláb, CSc.Hradec KrálovéCzechiaActive, not recruiting
Hospital JihlavaJihlava 1CzechiaActive, not recruiting
Fakultni Nemocnice Hradec KraloveNovy Hradec KraloveCzechiaActive, not recruiting
Fakultni nemocnice OstravaOstravaCzechiaActive, not recruiting
Hospital Universitari Vall d'HebronBarcelonaSpainActive, not recruiting
Bellvitge University HospitalL'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario La PazMadridSpainActive, not recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainActive, not recruiting
Poliklinika BONIFARMGrad ZagrebCroatiaActive, not recruiting
University Hospital Centre ZagrebGrad ZagrebCroatiaActive, not recruiting
Klinicki bolnicki centar Sestre milosrdniceGrad ZagrebCroatiaActive, not recruiting
Poliklinika Solmed d.o.o.Grad ZagrebCroatiaActive, not recruiting
Clinical Hospital Centre OsijekOsijekCroatiaActive, not recruiting
Clinical Hospital Centre RijekaRijekaCroatiaActive, not recruiting
Opca Bolnica VarazdinVarazdinCroatiaActive, not recruiting
NZOZ „PRO-FEMINA” Piotr Piech i in Spólka JawnaBedzinPolandActive, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.oGdanskPolandActive, not recruiting
NEURO-MEDIC Sp. z o. o.KatowicePolandActive, not recruiting
Novo-Med Zielinski I Wspolnicy Sp. j.KatowicePolandActive, not recruiting
Resmedica Sp. z o.o.KielcePolandActive, not recruiting
Centrum Neurologii Krzysztof SelmajŁódźPolandActive, not recruiting
Neurologiczny NZOZPlewiskaPolandActive, not recruiting
Centrum Medyczne HCP Sp. z o.o.PoznanPolandActive, not recruiting
Ilkowski I Partnerzy sp.p. LekarzyPoznanPolandActive, not recruiting
Med Polonia Sp z o.o.PoznanPolandActive, not recruiting
EUROMEDIS Sp z o oSzczecinPolandActive, not recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsawPolandActive, not recruiting
NeuroProtect Sp. z o.o.WarsawPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrzePolandActive, not recruiting
Clinhouse Sp. z o.o.ZabrzePolandActive, not recruiting
ProNeuro Centrum MedyczneZoryPolandActive, not recruiting
Arensia Clinics S.R.L.BucharestRomaniaActive, not recruiting
Clubul Sanatatii S.R.L.CampulungRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta ClujCluj-NapocaRomaniaActive, not recruiting
Spitalul Clinic De Neuropsihiatrie CraiovaCraiovaRomaniaActive, not recruiting
Pelican Impex S.R.L.OradeaRomaniaActive, not recruiting

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