En utvidelsesstudie av Ublituximab hos deltakere med residiverende multippel sklerose
En åpen utvidelsesstudie av Ublituximab hos personer med residiverende multippel sklerose
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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California
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Pasadena, California, Forente stater, 91105
- TG Therapeutics Investigational Trial Site
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Colorado
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Denver, Colorado, Forente stater, 80045
- TG Therapeutics Investigational Trial Site
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Florida
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Miami, Florida, Forente stater, 33136
- TG Therapeutics Investigational Trial Site
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Tampa, Florida, Forente stater, 33612
- TG Therapeutics Investigational Trial Site
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Illinois
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Northbrook, Illinois, Forente stater, 60062
- TG Therapeutics Investigational Trial Site
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- TG Therapeutics Investigational Trial Site
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Michigan
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Detroit, Michigan, Forente stater, 48201
- TG Therapeutics Investigational Trial Site
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- TG Therapeutics Investigational Trial Site
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New Jersey
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Teaneck, New Jersey, Forente stater, 07666
- TG Therapeutics Investigational Trial Site
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- TG Therapeutics Investigational Trial Site
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New York
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Amherst, New York, Forente stater, 14266
- TG Therapeutics Investigational Trial Site
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Ohio
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Columbus, Ohio, Forente stater, 43214
- TG Therapeutics Investigational Trial Site
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Westerville, Ohio, Forente stater, 43081
- TG Therapeutics Investigational Trial Site
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Tennessee
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Knoxville, Tennessee, Forente stater, 37922
- TG Therapeutics Investigational Trial Site
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Texas
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Dallas, Texas, Forente stater, 75246
- TG Therapeutics Investigational Trial Site
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Frisco, Texas, Forente stater, 75034
- TG Therapeutics Investigational Trial Site
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Round Rock, Texas, Forente stater, 78681
- TG Therapeutics Investigational Trial Site
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San Antonio, Texas, Forente stater, 78258
- TG Therapeutics Investigational Trial Site
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Washington
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Seattle, Washington, Forente stater, 98109
- TG Therapeutics 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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Grodno, Hviterussland, 230017
- TG Therapeutics Investigational Trial Site
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Grodno, Hviterussland, 320017
- TG Therapeutics Investigational Trial Site
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Minsk, Hviterussland, 220114
- TG Therapeutics Investigational Trial Site
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Minsk, Hviterussland, 220116
- TG Therapeutics Investigational Trial Site
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Minsk, Hviterussland, 220226
- TG Therapeutics Investigational Trial Site
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Osijek, Kroatia, 31000
- TG Therapeutics Investigational Trial Site
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Varaždin, Kroatia, 42000
- TG Therapeutics Investigational Trial Site
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Zagreb, Kroatia, 10000
- TG Investigational Trial Site
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Katowice, Polen, 40-555
- TG Therapeutics Investigational Trial Site
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Katowice, Polen, 40-568
- TG Therapeutics Investigational Trial Site
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Katowice, Polen, 40-684
- TG Therapeutics Investigational Trial Site
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Krakow, Polen, 31-505
- TG Therapeutics Investigational Trial Site
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Lodz, Polen, 41-800
- TG Therapeutics Investigational Trial Site
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Olsztyn, Polen, 10-561
- TG Therapeutics Investigational Trial Site
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Poznan, Polen, 61-583
- TG Therapeutics Investigational Trial Site
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Warsaw, Polen, 04-141
- TG Therapeutics Investigational Trial Site
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Zabrze, Polen, 04-749
- TG Therapeutics Investigational Trial Site
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Arkhangelsk, Russland, 163045
- TG Therapeutics Investigational Trial Site
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Barnaul, Russland, 656045
- TG Therapeutics Investigational Trial Site
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Bryansk, Russland, 241033
- TG Therapeutics Investigational Trial Site
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Chelyabinsk, Russland, 454021
- TG Therapeutics Investigational Trial Site
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Kemerovo, Russland, 650066
- TG Therapeutics Investigational Trial Site
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Krasnoyarsk, Russland, 660037
- TG Therapeutics Investigational Trial Site
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Kursk, Russland, 305007
- TG Therapeutics Investigational Trial Site
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Moscow, Russland, 125367
- TG Therapeutics Investigational Trial Site
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Moscow, Russland, 127015
- TG Therapeutics Investigational Trial Site
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Nizhny Novgorod, Russland, 603155
- TG Therapeutics Investigational Trial Site
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Novosibirsk, Russland, 630007
- TG Therapeutics Investigational Trial Site
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Novosibirsk, Russland, 630087
- TG Therapeutics Investigational Trial Site
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Pyatigorsk, Russland, 357538
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russland, 197002
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russland, 197110
- TG Therapeutics Investigational Trial Site
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Saint Petersburg, Russland, 197376
- TG Therapeutics Investigational Trial Site
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Saransk, Russland, 430032
- TG Therapeutics Investigational Trial Site
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Smolensk, Russland, 214018
- TG Therapeutics Investigational Trial Site
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Tomsk, Russland, 634050
- TG Therapeutics Investigational Trial Site
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Tyumen, Russland, 625000
- TG Therapeutics Investigational Trial Site
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Ufa, Russland, 450005
- TG Therapeutics Investigational Trial Site
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Yekaterinburg, Russland, 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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Cherkasy, Ukraina, 18009
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ukraina, 14001
- TG Therapeutics Investigational Trial Site
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Chernihiv, Ukraina, 14029
- TG Therapeutics Investigational Trial Site
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Chernivtsi, Ukraina, 58002
- TG Therapeutics Investigational Trial Site
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Ivano-Frankivsk, Ukraina, 76008
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ukraina, 61058
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ukraina, 61103
- TG Therapeutics Investigational Trial Site
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Kharkiv, Ukraina, 61176
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraina, 03037
- TG Therapeutics Investigational Trial Site
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Kyiv, Ukraina, 03115
- TG Therapeutics Investigational Trial Site
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Lviv, Ukraina, 79000
- TG Therapeutics Investigational Trial Site
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Lviv, Ukraina, 79010
- TG Therapeutics Investigational Trial Site
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Odesa, Ukraina, 65009
- TG Therapeutics Investigational Trial Site
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Poltava, Ukraina, 36011
- TG Therapeutics Investigational Trial Site
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Ternopil, Ukraina, 46027
- TG Therapeutics Investigational Trial Site
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Uzhhorod, Ukraina, 88018
- TG Therapeutics Investigational Trial Site
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Vinnytsia, Ukraina, 21005
- TG Therapeutics Investigational Trial Site
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Zaporizhia, Ukraina, 69065
- TG Therapeutics Investigational Trial Site
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Zaporizhia, Ukraina, 96900
- TG Therapeutics Investigational Trial Site
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Zhytomyr, Ukraina, 10002
- TG Therapeutics Investigational Trial Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Annualized Relapse Rate (ARR)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TG1101-RMS303
- 2019-003625-16 (EudraCT-nummer)
- 2019 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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