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Clinical Trials List

Protocol NumberCLOU064O12301
NCT Number(ClinicalTrials.gov Identfier)NCT06744920
Active

2025-01-01 - 2030-12-31

Phase III

Recruiting5

ICD-10G70.00

Myasthenia gravis without (acute) exacerbation

ICD-10G70.01

Myasthenia gravis with (acute) exacerbation

ICD-9358.0

Myasthenia gravis

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis (Taiwan) Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 蔡乃文 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSUEH-WEN HSUEH Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 葉建宏 Division of Neurology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuan-Ting Sun Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Long-Sun Ro
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Generalized Myasthenia Gravis

Objectives

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.

Test Drug

Remibrutinib

Active Ingredient

Remibrutinib

Dosage Form

tablets

Dosage

100mg

Endpoints

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score

Inclution Criteria

Inclusion Criteria:
• 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

Exclusion Criteria

Exclusion Criteria:
• 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
Other protocol-defined inclusion/exclusion criteria may apply.

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    180 participants

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