Studie for å evaluere opprettholdelsen av effektivitet ved overgang fra anti-klynge av differensierte 20 (CD20) terapi til Ublituximab (ENHANCE)
Evaluering av opprettholdelse av effektivitet ved overgang fra anti-CD20-terapi til Ublituximab
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK in Part B along with efficacy of ublituximab as measured by T1 Gd-enhancing lesions in participants who had a suboptimal experience on prior anti-CD20 therapy in Part C. The study consists of 3 parts: Part A is single-armed and open-label, Part B is randomized, double-blind, placebo-controlled, and Part C is single-armed and open-label.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: TG Therapeutics Clinical Support Team
- Telefonnummer: 1-877-575-8489
- E-post: clinicalsupport@tgtxinc.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35209
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- TG Therapeutics Investigational Trial Site
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Cullman, Alabama, Forente stater, 35058
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- TG Therapeutics Investigational Trial Site
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California
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Orange, California, Forente stater, 92697
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- TG Therapeutics Investigational Trial Site
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Colorado
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Fort Collins, Colorado, Forente stater, 80528
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- TG Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20007
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- TG Therapeutics Investigational Trial Site
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Florida
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Tampa, Florida, Forente stater, 33612
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Georgia
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Atlanta, Georgia, Forente stater, 30309
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- TG Therapeutics Investigational Trial Site
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Atlanta, Georgia, Forente stater, 30322
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- TG Therapeutics Investigational Trial Site
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Savannah, Georgia, Forente stater, 31406
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Illinois
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Chicago, Illinois, Forente stater, 60612
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- TG Therapeutics Investigational Trial Site
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Indiana
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Indianapolis, Indiana, Forente stater, 46256
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- TG Therapeutics Investigational Trial Site
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Iowa
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Iowa City, Iowa, Forente stater, 52242
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- TG Therapeutics Investigational Trial Site
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Kansas
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Overland Park, Kansas, Forente stater, 66212
- Fullført
- TG Therapeutics Investigational Trial Site
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Overland Park, Kansas, Forente stater, 66205
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- TG Therapeutics Investigational Trial Site
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Maryland
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Lutherville, Maryland, Forente stater, 21093
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- TG Therapeutics Investigational Trial Site
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Massachusetts
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Boston, Massachusetts, Forente stater, 70809
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- TG Therapeutics Investigational Trial Site
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Boston, Massachusetts, Forente stater, 00002
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- TG Therapeutics Investigational Trial Site
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Foxborough, Massachusetts, Forente stater, 02035
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- TG Therapeutics Investigational Trial Site
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North Worcester, Massachusetts, Forente stater, 01655
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- TG Therapeutics Investigational Trial Site
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Wellesley, Massachusetts, Forente stater, 02481
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- TG Therapeutics Investigational Trial Site
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Michigan
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Farmington, Michigan, Forente stater, 48334
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- TG Investigational Site
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Minnesota
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Golden Valley, Minnesota, Forente stater, 55422
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- TG Therapeutics Investigational Trial Site
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Plymouth, Minnesota, Forente stater, 55446
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- TG Therapeutics Investigational Trial Site
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Missouri
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St Louis, Missouri, Forente stater, 63131
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New York
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New York, New York, Forente stater, 10025
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New York, New York, Forente stater, 11021
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
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- TG Therapeutics Investigational Trial SiteCharlotte
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Raleigh, North Carolina, Forente stater, 27607
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- TG Therapeutics Investigational Trial Site
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Ohio
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Cincinnati, Ohio, Forente stater, 45212
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- TG Therapeutics Investigational Trial Site
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Cleveland, Ohio, Forente stater, 44195
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- TG Therapeutics Investigational Trial Site
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Dayton, Ohio, Forente stater, 45417
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- TG Therapeutics Investigational Trial Site
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
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Tennessee
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Knoxville, Tennessee, Forente stater, 37922
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Texas
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Houston, Texas, Forente stater, 77030
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- TG Therapeutics Investigational Trial Site
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Utah
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Salt Lake City, Utah, Forente stater, 84103
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- TG Therapeutics Investigational Trial Site
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Virginia
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Vienna, Virginia, Forente stater, 22182
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Washington
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Kirkland, Washington, Forente stater, 98034
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- TG Therapeutics Investigational Trial Site
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Seattle, Washington, Forente stater, 98109
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- TG Therapeutics Investigational Trial Site
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Spokane, Washington, Forente stater, 99208
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- TG Therapeutics Investigational Trial Site
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
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Bydgoszcz, Polen, 85-796
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- TG Therapeutics Investigational Trial Site
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Katowice, Polen, 40-555
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- TG Therapeutics Investigational Trial Site
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Kielce, Polen, 25-726
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- TG Therapeutics Investigational Trial Site
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Krakow, Polen, 31-826
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- TG Therapeutics Investigational Trial Site
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Lodz, Polen, 90-324
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- TG Therapeutics Investigational Trial Site
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Olsztyn, Polen, 10-561
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- TG Therapeutics Investigational Trial Site
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Poznan, Polen, 61-583
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- TG Therapeutics Investigational Trial Site
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Warsaw, Polen, 04-141
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- TG Therapeutics Investigational Trial Site
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Zabrze, Polen
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- TG Therapeutics Investigational Trial Site
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Żory, Polen, 44-240
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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:
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Diagnosis of RMS (2017 Revised McDonald criteria).
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Participants must meet one of the following prior treatment definitions:
- Participants naïve to treatment.
- Participants previously treated with a disease modifying therapy (DMT) who have discontinued treatment prior to consent and meet the washout requirements.
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Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
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Neurologically stable for > 30 days prior to first dose of ublituximab.
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Female participants of childbearing potential must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 6 months after the last dose of ublituximab.
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Part C: participants currently treated with an anti-CD20 agent for at least 6 months and meet the washout requirements prior to W1D1.
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Part C: Discontinuation of current anti-CD20 must be due to suboptimal experience
Exclusion Criteria:
- History of any serious 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
- Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
- Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
- Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
- Previous serious opportunistic or atypical infection.
- Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
- History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
- Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
- Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
- Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
- Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).
Note: Other Inclusion/Exclusion criteria may apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part A: Ublituximab
Participants will receive a modified regimen of ublituximab including infusions on Day 1 of Week 1 (W1D1), Day 15, if applicable, and ublituximab 450 milligrams (mg) infusion at Week 24. With Protocol Version 6.0, enrollment in Part A was closed. |
Administered as an intravenous (IV) infusion.
Andre navn:
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Eksperimentell: Part B: Ublituximab /Placebo (Treatment Arm A)
Participants will receive 600 mg of ublituximab on W1D1 followed by a placebo infusion on Day 15 and 450 mg ublituximab infusion at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed. |
IV infusion Administered as an intravenous (IV) infusion.
Andre navn:
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Eksperimentell: Part B: Ublituximab (Treatment Arm B)
Participants will receive 150 mg of ublituximab on W1D1 followed by 450 mg on Day 15 and at Week 24. With Protocol Version 7.0, enrollment in Part B will be closed. |
Administered as an intravenous (IV) infusion.
Andre navn:
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Eksperimentell: Part C: Ublituximab (Treatment Arm C)
Participants will receive 150 mg of ublituximab on W1D1, followed by 450 mg on Day 15 and at Week 24. |
Administered as an intravenous (IV) infusion.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Del B: Areal under kurven over de første 16 ukene (AUC0-W16) for Ublituximab
Tidsramme: Før dose og på flere tidspunkter opp til uke 16
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Før dose og på flere tidspunkter opp til uke 16
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Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48
Tidsramme: Baseline up to Week 48
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The Gd-enhancing T1 lesions will be evaluated using magnetic resonance imaging (MRI) technique. |
Baseline up to Week 48
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
Tidsramme: Week 48
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The Gd-enhancing T1 lesions will be evaluated using MRI technique. |
Week 48
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Parts A and B: Percentage of Participants Experiencing Infusion Related Reactions (IRRs)
Tidsramme: Up to Week 48
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IRRs are defined as infusion related adverse events (AEs) that occur within one day of an infusion and resolve within 7 days. IRRs will be reported by investigator. |
Up to Week 48
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Parts A: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Tidsramme: Part A: Baseline, Week 24 and Week 48
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The TSQM-9 is a 9-item questionnaire with 3 domains: Satisfaction, convenience, and effectiveness. |
Part A: Baseline, Week 24 and Week 48
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Samarbeidspartnere og etterforskere
Sponsor
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-RMS401
- 2024-519284-18-00 (Annen identifikator: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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