Studie om het behoud van de werkzaamheid te evalueren bij de overgang van anti-cluster van differentiatie 20 (CD20) therapie naar Ublituximab (ENHANCE)
Evaluatie van het behoud van de werkzaamheid bij de overgang van anti-CD20-therapie naar 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: TG Therapeutics Clinical Support Team
- Telefoonnummer: 1-877-575-8489
- E-mail: clinicalsupport@tgtxinc.com
Studie Locaties
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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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Alabama
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Birmingham, Alabama, Verenigde Staten, 35209
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- TG Therapeutics Investigational Trial Site
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Cullman, Alabama, Verenigde Staten, 35058
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- TG Therapeutics Investigational Trial Site
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California
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Orange, California, Verenigde Staten, 92697
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- TG Therapeutics Investigational Trial Site
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Colorado
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Fort Collins, Colorado, Verenigde Staten, 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, Verenigde Staten, 20007
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- TG Therapeutics Investigational Trial Site
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Florida
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Tampa, Florida, Verenigde Staten, 33612
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- TG Therapeutics Investigational Trial Site
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30309
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- TG Therapeutics Investigational Trial Site
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Atlanta, Georgia, Verenigde Staten, 30322
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- TG Therapeutics Investigational Trial Site
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Savannah, Georgia, Verenigde Staten, 31406
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- TG Therapeutics Investigational Trial Site
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
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- TG Therapeutics Investigational Trial Site
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46256
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- TG Therapeutics Investigational Trial Site
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Iowa
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Iowa City, Iowa, Verenigde Staten, 52242
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- TG Therapeutics Investigational Trial Site
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66212
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- TG Therapeutics Investigational Trial Site
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Overland Park, Kansas, Verenigde Staten, 66205
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- TG Therapeutics Investigational Trial Site
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Maryland
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Lutherville, Maryland, Verenigde Staten, 21093
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- TG Therapeutics Investigational Trial Site
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 70809
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- TG Therapeutics Investigational Trial Site
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Boston, Massachusetts, Verenigde Staten, 00002
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- TG Therapeutics Investigational Trial Site
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Foxborough, Massachusetts, Verenigde Staten, 02035
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- TG Therapeutics Investigational Trial Site
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North Worcester, Massachusetts, Verenigde Staten, 01655
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- TG Therapeutics Investigational Trial Site
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Wellesley, Massachusetts, Verenigde Staten, 02481
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- TG Therapeutics Investigational Trial Site
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Michigan
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Farmington, Michigan, Verenigde Staten, 48334
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- TG Investigational Site
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Minnesota
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Golden Valley, Minnesota, Verenigde Staten, 55422
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- TG Therapeutics Investigational Trial Site
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Plymouth, Minnesota, Verenigde Staten, 55446
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- TG Therapeutics Investigational Trial Site
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Missouri
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St Louis, Missouri, Verenigde Staten, 63131
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- TG Therapeutics Investigational Trial Site
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New York
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New York, New York, Verenigde Staten, 10025
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- TG Therapeutics Investigational Trial Site
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New York, New York, Verenigde Staten, 11021
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- TG Therapeutics Investigational Trial Site
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
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- TG Therapeutics Investigational Trial SiteCharlotte
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Raleigh, North Carolina, Verenigde Staten, 27607
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- TG Therapeutics Investigational Trial Site
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45212
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- TG Therapeutics Investigational Trial Site
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Cleveland, Ohio, Verenigde Staten, 44195
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- TG Therapeutics Investigational Trial Site
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Dayton, Ohio, Verenigde Staten, 45417
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- TG Therapeutics Investigational Trial Site
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
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- TG Therapeutics Investigational Trial Site
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29605
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37922
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- TG Therapeutics Investigational Trial Site
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Texas
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Houston, Texas, Verenigde Staten, 77030
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- TG Therapeutics Investigational Trial Site
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84103
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- TG Therapeutics Investigational Trial Site
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Virginia
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Vienna, Virginia, Verenigde Staten, 22182
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- TG Therapeutics Investigational Trial Site
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Washington
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Kirkland, Washington, Verenigde Staten, 98034
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- TG Therapeutics Investigational Trial Site
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Seattle, Washington, Verenigde Staten, 98109
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- TG Therapeutics Investigational Trial Site
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Spokane, Washington, Verenigde Staten, 99208
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- TG Therapeutics Investigational Trial Site
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Deel B: Oppervlak onder de curve gedurende de eerste 16 weken (AUC0-W16) van Ublituximab
Tijdsspanne: Vóór dosering en op meerdere tijdstippen tot week 16
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Vóór dosering en op meerdere tijdstippen tot week 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TG1101-RMS401
- 2024-519284-18-00 (Andere identificatie: EU CT Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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