Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
360
Countries
4
Sites
24
Relapsing forms of Multiple Sclerosis
To estimate the geometric mean ratio of area under the curve (AUC) of ublituximab when administered subcutaneously compared to IV administration
Key facts
- Sponsor
- Tg Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- TG Therapeutics, Inc.
External identifiers
- EU CT number
- 2025-521127-73-00
- WHO UTN
- U1111-1320-5618
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy, Safety, Efficacy, Pharmacokinetic
To estimate the geometric mean ratio of area under the curve (AUC) of ublituximab when administered subcutaneously compared to IV administration
Secondary objectives 4
- To assess the PK of ublituximab SC
- To assess the PD of ublituximab SC
- To assess the safety of ublituximab SC
- To assess the radiological effects of ublituximab SC
Conditions and MedDRA coding
Relapsing forms of Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10080700 | Relapsing multiple sclerosis | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. 18-65 years old
- 2. Diagnosis of RMS
- 3. Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening
- 4. Neurologically stable for > 30 days prior to Screening and Day 1
- 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 4
- 1. Primary-progressive MS (PPMS) or inactive Secondary Progressive MS (SPMS)
- 2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome
- 3. Participants with significantly impaired organ function (please refer to the protocol for the full information)
- For the full list please refer to the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Commercially confidential information
Secondary endpoints 2
- Proportion of participants with CD19+ B- cell (please ref to the protocol for the full information)
- Incidence of treatment emergent adverse events (TEAE)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12001815 · Product
- Active substance
- Ublituximab
- Substance synonyms
- Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 000 mg/ml milligram(s)/millilitre
- Max total dose
- 000 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- TG THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
PRD5447378 · Product
- Active substance
- Ublituximab
- Substance synonyms
- Recombinant chimeric monoclonal antibody against CD20, TG-1101, LFB-R603
- Other product name
- UTX, LFB-R603, TGTX1101
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L01XC — MONOCLONAL ANTIBODIES
- MA holder
- TG THERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tg Therapeutics Inc.
- Sponsor organisation
- Tg Therapeutics Inc.
- Address
- 3020 Carrington Mill Boulevard Suite 475
- City
- Morrisville
- Postcode
- 27560-5435
- Country
- United States
Scientific contact point
- Organisation
- Tg Therapeutics Inc.
- Contact name
- Clinical Support Team
Public contact point
- Organisation
- Tg Therapeutics Inc.
- Contact name
- Clinical Support Team
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Clinigen Clinical Supplies Management ORG-100034422
|
Mont-Saint-Guibert, Belgium | Code 14 |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 11, Code 12, Code 2, Code 5, Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| United Biosource LLC ORG-100027856
|
King Of Prussia, United States | Code 8 |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Neurorx Research Inc. ORG-100046079
|
Montreal, Canada | Other |
| CluePoints ORG-100050007
|
Ottignies-Louvain-La-Neuve, Belgium | Other |
| Clinigen Clinical Supplies Management GmbH ORG-100016915
|
Schwalbach Am Taunus, Germany | Code 14 |
Locations
4 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruitment ended | 32 | 9 |
| Croatia | Ongoing, recruitment ended | 11 | 3 |
| Czechia | Ongoing, recruitment ended | 23 | 6 |
| Hungary | Ongoing, recruitment ended | 18 | 6 |
| Rest of world
Bosnia and Herzegovina, North Macedonia, Georgia, Ukraine, Serbia
|
— | 276 | — |
Investigational sites
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Neurological Diseases Clinic, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Medical Center Medica 2005 EOOD
N/A, Ulitsa Milin Kamik 51, Lozenets District, Sofia
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Neurological Diseases Clinic for Locomotor Disorders, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Intensive Treatment of Neurological Diseases Clinic, Oborishte Distr., Ul.Byalo More 8, Sofia
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Neurological Diseases Clinic, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Diagnostic Consultation Center XX-Sofia EOOD
N/A, Ulitsa Gen. Stefan Toshev No. 15-17, 1618, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Neurological Diseases Clinic, Bulevard Peshtersko Shose 66, 4002, Plovdiv
Medical Center Academica 2008 EOOD
N/A, Ulitsa Todor Kableshkov 2, 5809, Pleven
Multiprofile Regional Hospital For Active Treatment Dr. Stefan Cherkezov AD
Department of Neurological Diseases, Ulitsa Nish 1, 5002, Veliko Tirnovo
Opca Bolnica Varazdin
Department of Neurology, Ulica Ivana Mestrovica 1, 42000, Varazdin
University Hospital Centre Zagreb
Department of Neurology, Ulica Mije Kispatica 12, 10000, Zagreb
Poliklinika Solmed d.o.o.
Department of Neurology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Fakultni Nemocnice Ostrava
Neurologická klinika, 17. Listopadu 1790/5, Poruba, Ostrava
Krajska Nemocnice T Bati a.s.
Neurologické oddělení, Havlickovo Nabrezi 600, 760 01, Zlin
Nemocnice Jihlava prispevkova organizace
Neurologické oddělení, Vrchlickeho 4630/59, 586 01, Jihlava 1
Fakultni Nemocnice Hradec Kralove
Neurologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Nemocnice Pardubickeho kraje a.s.
Neurologické oddělení, Kyjevska 44 Pardubicky, 530 03, Pardubice
Fakultni Nemocnice U Sv Anny V Brne
I. neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
S-Medicon Kft.
N/A, Megyeri Ut 53, 1044, Budapest IV
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department of Neurology, Tallian Gyula Utca 20-32, 7400, Kaposvar
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Budapesti Uzsoki Utcai Korhaz
Department of Neurology. The other entrance of the hospital: 1145 Budapest, Rona u. 196-212., Uzsoki Utca 29-41, 1145, Budapest XIV
University Of Pecs
Dpartment of Neurology, Ret Utca 2, 7623, Pecs
Kistarcsai Flor Ferenc Korhaz
Department of Neurology and Stroke, Semmelweis Ter 1, 2143, Kistarcsa
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2025-10-07 | 2025-10-15 | 2026-03-31 | ||
| Croatia | 2025-09-12 | 2025-10-15 | 2026-03-31 | ||
| Czechia | 2025-09-23 | 2025-09-30 | 2026-03-31 | ||
| Hungary | 2025-09-17 | 2025-10-20 | 2026-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 35 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-521127-73-00_Redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_TASQ_Placeholder for publication | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum for Future Research | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum for Future Research | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dummy Run MRI_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dummy Run MRI_HU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Evaluation_EN_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Evaluations_HU_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HU_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dummy MRI_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR Pregnant participant | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI Dummy run_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MRI_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional future research | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Subject_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_HU_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis for laypersons HU_2025-521127-73-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis for Laypersons_2025-521127-73-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis for Laypersons_BG_2025-521127-73-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis for Laypersons_CZ_2025-521127-73-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis for Laypersons_HR_2025-521127-73-00 | NA |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-25 | Czechia | Acceptable 2025-08-18
|
2025-08-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-26 | Czechia | Acceptable 2026-02-09
|
2026-02-09 |