Clinical trial • Phase III • Neurology

UBLITUXIMAB for Relapsing multiple sclerosis

Phase III trial of UBLITUXIMAB for Relapsing multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Relapsing multiple sclerosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
25-04-2025
First CTIS Authorization Date
19-08-2025

Trial design

Randomised, open-label, intravenous ublituximab (ublituximab, solution for infusion) used as comparator; dose and schedule not specified in the ctis record.-controlled Phase III trial in Bulgaria, Croatia, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Intravenous ublituximab (ublituximab, solution for infusion) used as comparator; dose and schedule not specified in the CTIS record.
Target Sample Size
276

Eligibility

Recruits 276 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms (multiple versions and languages) are provided in the CTIS documents. No specific assent or alternative consent procedures for vulnerable participants are described in the provided CTIS record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms (multiple versions and languages) are provided in the CTIS documents. No specific assent or alternative consent procedures for vulnerable participants are described in the provided CTIS record.

Inclusion criteria

  • {"criterion_text":"- 1.\t18-65 years old\n- 2.\tDiagnosis of RMS\n- 3. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening\n- 4. Neurologically stable for > 30 days prior to Screening and Day 1\n- 5. Female participants of childbearing potential must consent to use a highly effective method of contraception from consent and for 6 months after the last dose of ublituximab"}

Exclusion criteria

  • {"criterion_text":"- 1. Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)\n- 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome\n- 3. Participants with significantly impaired organ function (please refer to the protocol for the full information)\n- For the full list please refer to the protocol"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Commercially confidential information","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants with CD19+ B- cell (please ref to the protocol for the full information)","definition_or_measurement_approach":"Please refer to the protocol for the full information"}
  • {"endpoint_text":"- Incidence of treatment emergent adverse events (TEAE)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
276
Recruitment Window Months
30
Consent Approach
Informed consent is required from participants. Subject information and informed consent forms (multiple versions, languages, and specific documents such as MRI and pregnancy participant ICFs) are provided in CTIS. No additional details on assent, surrogate consent, or special consent processes are provided in the CTIS record.

Geography

Total Number Of Sites
25
Total Number Of Participants
84

Bulgaria

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
186
Number Of Sites
9
Number Of Participants
32

Sites

Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Neurological Diseases Clinic
Contact Person Name
Maria Dimitrova
Contact Person Email
Dr.m.i.dimitrov@gmail.com
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Intensive Treatment of Neurological Diseases Clinic
Contact Person Name
Evgenia Vasileva Roustcheva
Contact Person Email
dr.evgenia.vasileva@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Neurological Diseases Clinic
Contact Person Name
Penko Shotekov
Contact Person Email
shotekov@abv.bg
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Neurological Diseases Clinic for Locomotor Disorders
Contact Person Name
Ivan Milanov
Contact Person Email
milanovivan54@gmail.com
Site Name
Medical Center Medica 2005 EOOD
Contact Person Name
Valentina Ignatova - Valkova
Contact Person Email
valyaig@abv.bg
Site Name
Medical Center Academica 2008 EOOD
Contact Person Name
Plamen Tsvetanov
Contact Person Email
tsvetanovmd@mail.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Neurological Diseases Clinic
Contact Person Name
Penka Atanasova
Contact Person Email
pepiatanasova123@gmail.com
Site Name
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
Department Name
Department of Neurological Diseases
Contact Person Name
Angel Angelov
Contact Person Email
angelov_md@mail.bg
Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Contact Person Name
Tsocho Kmetski
Contact Person Email
ts.kmetski@mail.bg

Croatia

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
217
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Opca Bolnica Varazdin
Department Name
Department of Neurology
Contact Person Name
Spomenka Kidjemet - Piskac
Contact Person Email
spomenka.piskac@obv.hr
Site Name
Poliklinika Solmed d.o.o.
Department Name
Department of Neurology
Contact Person Name
Hrvoje Budincevic
Site Name
University Hospital Centre Zagreb
Department Name
Department of Neurology
Contact Person Name
Mario Habek
Contact Person Email
mario.habek@mef.hr

Czechia

Earliest CTIS Part Ii Submission Date
08-08-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
185
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Krajska Nemocnice T Bati a.s.
Department Name
Neurologické oddělení
Contact Person Name
Eva Recmanová
Contact Person Email
eva.recmanova@bnzlin.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Neurologická klinika
Contact Person Name
Pavel Hradílek
Contact Person Email
pavel.hradilek@fno.cz
Site Name
Nemocnice Pardubickeho kraje a.s.
Department Name
Neurologické oddělení
Contact Person Name
Miroslav Mareš
Contact Person Email
miroslav.mares@nmpk.cz
Site Name
Nemocnice Jihlava prispevkova organizace
Department Name
Neurologické oddělení
Contact Person Name
Ondřej Škoda
Contact Person Email
skodao@nemji.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologická klinika
Contact Person Name
Zbyšek Pavelek
Contact Person Email
zbysek.pavelek@fnhk.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. neurologická klinika
Contact Person Name
Michal Dufek
Contact Person Email
michal.dufek@fnusa.cz
Site Name
Nemocnice Pardubickeho kraje a.s. (duplicate listing if present)
Department Name
Neurologické oddělení

Hungary

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
185
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Department of Neurology
Contact Person Name
Istvan Deme
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Department of Neurology. The other entrance of the hospital: 1145 Budapest, Rona u. 196-212.
Contact Person Name
Gabor Jakab
Contact Person Email
jakabg@uzsoki.hu
Site Name
Clinexpert Kft.
Contact Person Name
Ferenc Fazekas
Contact Person Email
rendeles@clinexpert.hu
Site Name
University Of Pecs
Department Name
Dpartment of Neurology
Contact Person Name
Peter Acs
Contact Person Email
acs.peter@pte.hu
Site Name
Kistarcsai Flor Ferenc Korhaz
Department Name
Department of Neurology and Stroke
Contact Person Name
Zita Biro
Contact Person Email
neurologia@florhosp.hu
Site Name
S-Medicon Kft.
Contact Person Name
Maria Satori
Contact Person Email
info@medcity.hu

Sponsor

Primary sponsor

Full Name
Tg Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Psi Cro AG
Responsibilities
1,11,12,2,5,6

Third parties

  • {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"1,11,12,2,5,6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Charles River Laboratories International Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"United Biosource LLC","duties_or_roles":"8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"15 (Central Imaging Reader)","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"15 (Risk Based Monitoring)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ublituximab (subcutaneous formulation)
Active Substance
UBLITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
ublituximab (intravenous formulation)
Active Substance
UBLITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
Intravenous
Authorisation Status
Authorised

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