A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis (RELIEVE)

Novartis

Status and phase: Enrolling; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Remibrutinib (Blinded); Drug: Remibrutinib (Open Label); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06744920

CLOU064O12301

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Remibrutinib arm

Experimental group

Description:

Core Part: Remibrutinib tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\]

Treatment:

Drug: Remibrutinib (Open Label)

Drug: Remibrutinib (Blinded)

Placebo arm

Placebo Comparator group

Description:

Core Part: Placebo tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\]

Treatment:

Other: Placebo

Drug: Remibrutinib (Open Label)