Uno studio di estensione di ublituximab nei partecipanti con sclerosi multipla recidivante
Uno studio di estensione in aperto di ublituximab in soggetti con sclerosi multipla recidivante
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
TG1101-RMS303 is an open-label, single-arm extension study designed to evaluate long-term safety and efficacy of ublituximab in participants with RMS. Participants who complete the 96-week, double-blind treatment period of TG1101-RMS301 (RMS301 [NCT03277261]) or TG1101-RMS302 (RMS302 [NCT03277248]) are eligible for participation in this Open Label Extension (OLE) study. Participants may also be eligible for TG1101-RMS303 if they have completed Week 208 of TG1101-RMS201E (RMS201E [NCT03381170]) (United States of America [USA] participants only).
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Grodno, Bielorussia, 230017
- TG Therapeutics Investigational Trial Site
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Grodno, Bielorussia, 320017
- TG Therapeutics Investigational Trial Site
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Minsk, Bielorussia, 220114
- TG Therapeutics Investigational Trial Site
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Minsk, Bielorussia, 220116
- TG Therapeutics Investigational Trial Site
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Minsk, Bielorussia, 220226
- TG Therapeutics Investigational Trial Site
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Osijek, Croazia, 31000
- TG Therapeutics Investigational Trial Site
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Varaždin, Croazia, 42000
- TG Therapeutics Investigational Trial Site
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Zagreb, Croazia, 10000
- TG Investigational Trial Site
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Tbilisi, Georgia, 00112
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 00114
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 00159
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 00160
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 00172
- TG Therapeutics Investigational Trial Site
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Tbilisi, Georgia, 00179
- TG Therapeutics Investigational Trial Site
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Katowice, Polonia, 40-555
- TG Therapeutics Investigational Trial Site
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Katowice, Polonia, 40-568
- TG Therapeutics Investigational Trial Site
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Katowice, Polonia, 40-684
- TG Therapeutics Investigational Trial Site
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Krakow, Polonia, 31-505
- TG Therapeutics Investigational Trial Site
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Lodz, Polonia, 41-800
- TG Therapeutics Investigational Trial Site
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Olsztyn, Polonia, 10-561
- TG Therapeutics Investigational Trial Site
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Poznan, Polonia, 61-583
- TG Therapeutics Investigational Trial Site
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Warsaw, Polonia, 04-141
- TG Therapeutics Investigational Trial Site
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Zabrze, Polonia, 04-749
- TG Therapeutics Investigational Trial Site
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Arkhangelsk, Russia, 163045
- TG Therapeutics Investigational Trial Site
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Barnaul, Russia, 656045
- TG Therapeutics Investigational Trial Site
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Bryansk, Russia, 241033
- TG Therapeutics Investigational Trial Site
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Chelyabinsk, Russia, 454021
- TG Therapeutics Investigational Trial Site
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Kemerovo, Russia, 650066
- TG Therapeutics Investigational Trial Site
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Krasnoyarsk, Russia, 660037
- TG Therapeutics Investigational Trial Site
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Kursk, Russia, 305007
- TG Therapeutics Investigational Trial Site
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Moscow, Russia, 125367
- TG Therapeutics Investigational Trial Site
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Moscow, Russia, 127015
- TG Therapeutics Investigational Trial Site
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Nizhny Novgorod, Russia, 603155
- TG Therapeutics Investigational Trial Site
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Novosibirsk, Russia, 630007
- TG Therapeutics Investigational Trial Site
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Novosibirsk, Russia, 630087
- TG Therapeutics Investigational Trial Site
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Pyatigorsk, Russia, 357538
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russia, 197002
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russia, 197110
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russia, 197376
- TG Therapeutics Investigational Trial Site
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Saransk, Russia, 430032
- TG Therapeutics Investigational Trial Site
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Smolensk, Russia, 214018
- TG Therapeutics Investigational Trial Site
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Tomsk, Russia, 634050
- TG Therapeutics Investigational Trial Site
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Tyumen, Russia, 625000
- TG Therapeutics Investigational Trial Site
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Ufa, Russia, 450005
- TG Therapeutics Investigational Trial Site
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Yekaterinburg, Russia, 620102
- TG Therapeutics Investigational Trial Site
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Belgrade, Serbia, 11000
- TG Therapeutics Investigational Trial Site
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Kragujevac, Serbia, 34000
- TG Therapeutics Investigational Trial Site
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California
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Pasadena, California, Stati Uniti, 91105
- TG Therapeutics Investigational Trial Site
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Colorado
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Denver, Colorado, Stati Uniti, 80045
- TG Therapeutics Investigational Trial Site
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Florida
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Miami, Florida, Stati Uniti, 33136
- TG Therapeutics Investigational Trial Site
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Tampa, Florida, Stati Uniti, 33612
- TG Therapeutics Investigational Trial Site
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Illinois
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Northbrook, Illinois, Stati Uniti, 60062
- TG Therapeutics Investigational Trial Site
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- TG Therapeutics Investigational Trial Site
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Michigan
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Detroit, Michigan, Stati Uniti, 48201
- TG Therapeutics Investigational Trial Site
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- TG Therapeutics Investigational Trial Site
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New Jersey
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Teaneck, New Jersey, Stati Uniti, 07666
- TG Therapeutics Investigational Trial Site
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131
- TG Therapeutics Investigational Trial Site
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New York
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Amherst, New York, Stati Uniti, 14266
- TG Therapeutics Investigational Trial Site
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Ohio
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Columbus, Ohio, Stati Uniti, 43214
- TG Therapeutics Investigational Trial Site
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Westerville, Ohio, Stati Uniti, 43081
- TG Therapeutics Investigational Trial Site
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37922
- TG Therapeutics Investigational Trial Site
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Texas
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Dallas, Texas, Stati Uniti, 75246
- TG Therapeutics Investigational Trial Site
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Frisco, Texas, Stati Uniti, 75034
- TG Therapeutics Investigational Trial Site
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Round Rock, Texas, Stati Uniti, 78681
- TG Therapeutics Investigational Trial Site
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San Antonio, Texas, Stati Uniti, 78258
- TG Therapeutics Investigational Trial Site
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Washington
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Seattle, Washington, Stati Uniti, 98109
- TG Therapeutics Investigational Trial Site
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Cherkasy, Ucraina, 18009
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ucraina, 14001
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ucraina, 14029
- TG Therapeutics Investigational Trial Site
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Chernivtsi, Ucraina, 58002
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk, Ucraina, 76008
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ucraina, 61058
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ucraina, 61103
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ucraina, 61176
- TG Therapeutics Investigational Trial Site
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Kyiv, Ucraina, 03037
- TG Therapeutics Investigational Trial Site
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Kyiv, Ucraina, 03115
- TG Therapeutics Investigational Trial Site
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Lviv, Ucraina, 79000
- TG Therapeutics Investigational Trial Site
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Lviv, Ucraina, 79010
- TG Therapeutics Investigational Trial Site
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Odesa, Ucraina, 65009
- TG Therapeutics Investigational Trial Site
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Poltava, Ucraina, 36011
- TG Therapeutics Investigational Trial Site
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Ternopil, Ucraina, 46027
- TG Therapeutics Investigational Trial Site
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Uzhhorod, Ucraina, 88018
- TG Therapeutics Investigational Trial Site
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Vinnytsia, Ucraina, 21005
- TG Therapeutics Investigational Trial Site
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Zaporizhia, Ucraina, 69065
- TG Therapeutics Investigational Trial Site
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Zaporizhia, Ucraina, 96900
- TG Therapeutics Investigational Trial Site
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Zhytomyr, Ucraina, 10002
- TG Therapeutics Investigational Trial Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Participants must meet the following criteria:
- Complete the 96-week double-blind TG1101-RMS301 (NCT03277261) or TG1101-RMS302 (NCT03277248) study or complete the final Week 208 visit of the TG1101-RMS201E (NCT03381170) study
- Investigator believes may benefit from treatment with ublituximab
- Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
- Female participants of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
Exclusion Criteria:
Participants who meet any of the following exclusion criteria are not to be enrolled to this study:
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Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
- Absolute neutrophil count < 1.5 x 10e3/µL
- Hematocrit < 24%
- Platelet count < 150,000 cell/mm^3
- Hypogammaglobulinemia immunoglobulin G (IgG) < 4.0g/L
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Active infection
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Ongoing pregnancy (female participants)
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Participants who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period or prior to completing the final Week 208 visit of the TG1101-RMS201E study
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Participants who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, or after completing the final Week 208 visit of the TG1101-RMS201E study
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Participants who have had a confirmed multiple sclerosis (MS) relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, participants must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE
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Participants with unstable disease activity
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Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
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Vaccination with live virus within 2 months of randomization
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Ublituximab Infusions
RMS301/RMS302: All participants transferring from RMS301/RMS302 who sign consent for this study will receive an initial 4-hour infusion of 150 mg ublituximab on Week 1 (Day 1) followed by a 1-hour infusion of 450 mg ublituximab 14 days later Week 3 (Day 15). Subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. RMS201E: All participants transferring from RMS201E who sign consent for this study will receive a 1-hour infusion of 450 mg ublituximab on Week 1 (Day 1) and subsequent infusions of ublituximab will be administered at 450 mg for 1-hour every 24 weeks from Weeks 24 to 312. For all participants (RMS301/RMS302/RMS201E), infusion treatment will continue for 312 weeks, or until physician or participant decision to withdraw from the study. |
Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Annualized Relapse Rate (ARR)
Lasso di tempo: Up to Week 336
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ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years). |
Up to Week 336
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TG1101-RMS303
- 2019-003625-16 (Numero EudraCT)
- 2019 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .