WHO ICTRP trial

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological…

CTIS2025-521127-73-00 · EU Clinical Trials Information System · Recruiting

Key facts

Trial ID CTIS2025-521127-73-00
Public title A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis
Scientific title A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects Of Subcutaneous Ublituximab Versus Intravenous Ublituximab In Patients With Multiple Sclerosis - TG1101-RMS-SC301
Primary sponsor Tg Therapeutics Inc.
Registry EU Clinical Trials Information System
Recruitment status Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No
Countries Bosnia and Herzegovina;North Macedonia;Ukraine;Serbia;Georgia;Bulgaria;Croatia;Czechia;Hungary
Conditions Relapsing forms of Multiple Sclerosis MedDRA version: 27.0Level: PTClassification code: 10080700Term: Relapsing multiple sclerosis Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Interventions Product Name: Ublituximab, Product Code:PRD12001815, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: ublituximab, Product Code:PRD5447378, Pharmaceutical Form: CONCENTRATE FOR SOLUTION FOR…
Registration date Apr 25, 2025
Target size 360
Secondary IDs U1111-1320-5618
Registry page euclinicaltrials.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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