A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Remibrutinib in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06744920Tipo: INTERVENTIONALInicio: 7 de feb de 2025Fin estimado: 26 de feb de 2033

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Resumen

A study to evaluate the efficacy, safety and tolerability of Remibrutinib versus placebo in adult patients with Generalized Myasthenia Gravis who are on stable, standard-of-care (SOC) treatment.

Descripción detallada

This study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate the efficacy, safety and tolerability of remibrutinib in gMG patients who are on stable SOC treatment. Approximately 180 eligible participants will be randomized in a ratio of 1:1, to receive either remibrutinib or matching placebo. The study consists of a Core Part (6-months double-blind treatment) and an Extension Part (up to 60-month open-label treatment).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Adult patients with gMG (age 18-75 years)
Confirmed diagnosis of Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG at screening and likely not in need of a respirator for the duration of the study, as judged by the Investigator
Documented evidence of positive serologic testing for AChR+ antibody or MuSK+ antibody at screening, OR seronegative for both AChR and MuSK antibodies at screening
Baseline MG-ADL score ≥ 6 with ≥ 50% of the total score due to non ocular symptoms
Participants who have been on a stable dose of standard-of-care treatment as specified in the protocol
Able to safely swallow the study medication according to investigator clinical judgement based on a bedside swallowing test or another formal swallowing test in line with local practice, both at Screening and Baseline

Criterios de exclusión

Prior to baseline have been treated with intravenous immunoglobulins or plasma exchange (IVIg/PLEX) in the past month, with rituximab in the past 6 months, eculizumab in the past 2 months, ravulizumab or other complement inhibitors in the past 3 months, efgartigimod or other anti-FcRn therapies in the past 3 months, or had a thymectomy in the past 6 months or a planned thymectomy during the trial period
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of study treatment

Intervenciones

drug

Remibrutinib (Blinded)

Remibrutinib (Blinded) active treatment

other

Placebo

drug

Remibrutinib (Open Label)

Remibrutinib (Open Label) active treatment

Ubicaciones

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

RECRUITING

Novartis Investigative Site

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

CONTACT

+41613241111

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