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
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.
- Diseases
- Multiple sclerosis
- 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
Sites (49)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile Hospital For Active Treatment Elin Pelin EOOD | Elin Pelin | Bulgaria | Active, not recruiting |
| Medical Center Hera EOOD | Montana | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. | Panagyurishte | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment Avis Medika OOD | Pleven | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD | Pleven | Bulgaria | Active, not recruiting |
| Alexandrovska University Hospital | Sofia | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD | Sofia | Bulgaria | Active, not recruiting |
| Medicinski Center Syrtuin Ltd. | Sofia | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD | Sofia | Bulgaria | Active, not recruiting |
| Medical Center Hera EOOD | Sofiya | Bulgaria | Active, not recruiting |
| Multiprofessional Hospital For Active Treatment Health 2012 OOD | Sofiya | Bulgaria | Active, not recruiting |
| Sveta Marina Pharma EOOD | Varna | Bulgaria | Active, not recruiting |
| NEUROHK s r o | Choceň | Czechia | Active, not recruiting |
| doc. MUDr. Radomír Taláb, CSc. | Hradec Králové | Czechia | Active, not recruiting |
| Hospital Jihlava | Jihlava 1 | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | Active, not recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Active, not recruiting |
| Bellvitge University Hospital | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Active, not recruiting |
| Poliklinika BONIFARM | Grad Zagreb | Croatia | Active, not recruiting |
| University Hospital Centre Zagreb | Grad Zagreb | Croatia | Active, not recruiting |
| Klinicki bolnicki centar Sestre milosrdnice | Grad Zagreb | Croatia | Active, not recruiting |
| Poliklinika Solmed d.o.o. | Grad Zagreb | Croatia | Active, not recruiting |
| Clinical Hospital Centre Osijek | Osijek | Croatia | Active, not recruiting |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia | Active, not recruiting |
| Opca Bolnica Varazdin | Varazdin | Croatia | Active, not recruiting |
| NZOZ „PRO-FEMINA” Piotr Piech i in Spólka Jawna | Bedzin | Poland | Active, not recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o | Gdansk | Poland | Active, not recruiting |
| NEURO-MEDIC Sp. z o. o. | Katowice | Poland | Active, not recruiting |
| Novo-Med Zielinski I Wspolnicy Sp. j. | Katowice | Poland | Active, not recruiting |
| Resmedica Sp. z o.o. | Kielce | Poland | Active, not recruiting |
| Centrum Neurologii Krzysztof Selmaj | Łódź | Poland | Active, not recruiting |
| Neurologiczny NZOZ | Plewiska | Poland | Active, not recruiting |
| Centrum Medyczne HCP Sp. z o.o. | Poznan | Poland | Active, not recruiting |
| Ilkowski I Partnerzy sp.p. Lekarzy | Poznan | Poland | Active, not recruiting |
| Med Polonia Sp z o.o. | Poznan | Poland | Active, not recruiting |
| EUROMEDIS Sp z o o | Szczecin | Poland | Active, not recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy | Warsaw | Poland | Active, not recruiting |
| NeuroProtect Sp. z o.o. | Warsaw | Poland | Active, not recruiting |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach | Zabrze | Poland | Active, not recruiting |
| Clinhouse Sp. z o.o. | Zabrze | Poland | Active, not recruiting |
| ProNeuro Centrum Medyczne | Zory | Poland | Active, not recruiting |
| Arensia Clinics S.R.L. | Bucharest | Romania | Active, not recruiting |
| Clubul Sanatatii S.R.L. | Campulung | Romania | Active, not recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj | Cluj-Napoca | Romania | Active, not recruiting |
| Spitalul Clinic De Neuropsihiatrie Craiova | Craiova | Romania | Active, not recruiting |
| Pelican Impex S.R.L. | Oradea | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.