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

Conditions

• Generalized Myasthenia Gravis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib (Blinded) — DRUG
  Remibrutinib (Blinded) active treatment
• Placebo — OTHER
  Placebo
• Remibrutinib (Open Label) — DRUG
  Remibrutinib (Open Label) active treatment

Study Details

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.

Key Dates

Start date

Feb 7, 2025

Status verified

May 2026

Primary completion

Feb 25, 2028

Completion

Feb 26, 2033

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Remibrutinib arm
  Core Part: Remibrutinib tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\]
• Placebo Comparator: Placebo arm
  Core Part: Placebo tablet taken orally \[Extension Part: Open-label remibrutinib tablet taken orally\]

Primary Outcome Measure

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score [ Time Frame: Baseline to Month 6 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (24)

Find similar trials in Phoenix, AZ

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