Estudo para avaliar a manutenção da eficácia durante a transição da terapia anti-cluster de diferenciação 20 (CD20) para ublituximabe (ENHANCE)
Avaliando a manutenção da eficácia ao fazer a transição da terapia anti-CD20 para ublituximabe
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: TG Therapeutics Clinical Support Team
- Número de telefone: 1-877-575-8489
- E-mail: clinicalsupport@tgtxinc.com
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
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- TG Therapeutics Investigational Trial Site
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Cullman, Alabama, Estados Unidos, 35058
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- TG Therapeutics Investigational Trial Site
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California
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Orange, California, Estados Unidos, 92697
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- TG Therapeutics Investigational Trial Site
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Colorado
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Fort Collins, Colorado, Estados Unidos, 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, Estados Unidos, 20007
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- TG Therapeutics Investigational Trial Site
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Florida
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Tampa, Florida, Estados Unidos, 33612
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- TG Therapeutics Investigational Trial Site
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
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- TG Therapeutics Investigational Trial Site
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Atlanta, Georgia, Estados Unidos, 30322
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- TG Therapeutics Investigational Trial Site
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Savannah, Georgia, Estados Unidos, 31406
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- TG Therapeutics Investigational Trial Site
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
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- TG Therapeutics Investigational Trial Site
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46256
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- TG Therapeutics Investigational Trial Site
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
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- TG Therapeutics Investigational Trial Site
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Kansas
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Overland Park, Kansas, Estados Unidos, 66212
- Concluído
- TG Therapeutics Investigational Trial Site
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Overland Park, Kansas, Estados Unidos, 66205
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- TG Therapeutics Investigational Trial Site
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Maryland
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Lutherville, Maryland, Estados Unidos, 21093
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- TG Therapeutics Investigational Trial Site
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 70809
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- TG Therapeutics Investigational Trial Site
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Boston, Massachusetts, Estados Unidos, 00002
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- TG Therapeutics Investigational Trial Site
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Foxborough, Massachusetts, Estados Unidos, 02035
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- TG Therapeutics Investigational Trial Site
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North Worcester, Massachusetts, Estados Unidos, 01655
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- TG Therapeutics Investigational Trial Site
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Wellesley, Massachusetts, Estados Unidos, 02481
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- TG Therapeutics Investigational Trial Site
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Michigan
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Farmington, Michigan, Estados Unidos, 48334
- Recrutamento
- TG Investigational Site
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Minnesota
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Golden Valley, Minnesota, Estados Unidos, 55422
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- TG Therapeutics Investigational Trial Site
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Plymouth, Minnesota, Estados Unidos, 55446
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- TG Therapeutics Investigational Trial Site
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Missouri
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St Louis, Missouri, Estados Unidos, 63131
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- TG Therapeutics Investigational Trial Site
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New York
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New York, New York, Estados Unidos, 10025
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- TG Therapeutics Investigational Trial Site
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New York, New York, Estados Unidos, 11021
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- TG Therapeutics Investigational Trial Site
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Recrutamento
- TG Therapeutics Investigational Trial SiteCharlotte
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Raleigh, North Carolina, Estados Unidos, 27607
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- TG Therapeutics Investigational Trial Site
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45212
- Recrutamento
- TG Therapeutics Investigational Trial Site
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Cleveland, Ohio, Estados Unidos, 44195
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- TG Therapeutics Investigational Trial Site
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Dayton, Ohio, Estados Unidos, 45417
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- TG Therapeutics Investigational Trial Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
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- TG Therapeutics Investigational Trial Site
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29605
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- TG Therapeutics Investigational Trial Site
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37922
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- TG Therapeutics Investigational Trial Site
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Texas
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Houston, Texas, Estados Unidos, 77030
- Concluído
- TG Therapeutics Investigational Trial Site
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Utah
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Salt Lake City, Utah, Estados Unidos, 84103
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- TG Therapeutics Investigational Trial Site
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Virginia
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Vienna, Virginia, Estados Unidos, 22182
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- TG Therapeutics Investigational Trial Site
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Washington
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Kirkland, Washington, Estados Unidos, 98034
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- TG Therapeutics Investigational Trial Site
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Seattle, Washington, Estados Unidos, 98109
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- TG Therapeutics Investigational Trial Site
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Spokane, Washington, Estados Unidos, 99208
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- TG Therapeutics Investigational Trial Site
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53226
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- TG Therapeutics Investigational Trial Site
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Bydgoszcz, Polônia, 85-796
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- TG Therapeutics Investigational Trial Site
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Katowice, Polônia, 40-555
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- TG Therapeutics Investigational Trial Site
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Kielce, Polônia, 25-726
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- TG Therapeutics Investigational Trial Site
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Krakow, Polônia, 31-826
- Recrutamento
- TG Therapeutics Investigational Trial Site
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Lodz, Polônia, 90-324
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- TG Therapeutics Investigational Trial Site
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Olsztyn, Polônia, 10-561
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- TG Therapeutics Investigational Trial Site
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Poznan, Polônia, 61-583
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- TG Therapeutics Investigational Trial Site
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Warsaw, Polônia, 04-141
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- TG Therapeutics Investigational Trial Site
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Zabrze, Polônia
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- TG Therapeutics Investigational Trial Site
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Żory, Polônia, 44-240
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- TG Therapeutics Investigational Trial Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Parte B: Área Sob a Curva Durante as Primeiras 16 Semanas (AUC0-W16) de Ublituximab
Prazo: Antes da dose e em múltiplos momentos até à Semana 16
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Antes da dose e em múltiplos momentos até à Semana 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Parts A: Percentage of Participants Free of T1 Gd-Enhancing Lesions
Prazo: 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)
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TG1101-RMS401
- 2024-519284-18-00 (Outro identificador: EU CT Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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