Study of Aritinercept in Patients With Generalized Myasthenia Gravis

Phase 2RecruitingNCT07596901

Aurinia Pharmaceuticals Inc.81 enrolled

Overview

This clinical study will enroll patients with generalized myasthenia gravis (gMG). The goal of this clinical study is to assess the safety, tolerability, effectiveness, pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) of aritinercept.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Myasthenia Gravis, Generalized

Interventions

AritinerceptDRUG

For subcutaneous injection

PlaceboOTHER

For subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Adult patients (18-85 years old) * Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG * Additional inclusion criteria are defined in the protocol Key Exclusion Criteria: * Current or medical history of malignancy within the last 5 years * Pregnant, breastfeeding or intending to become pregnant during the Study * Additional exclusion criteria are defined in the protocol

Locations (11)

Aurinia Investigational Site

Pasadena, California, United States

RECRUITING

Aurinia Investigational Site

Altamonte Springs, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events

Time frame: Baseline to study completion, up to 73 weeks

Secondary Outcomes

To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score

Time frame: Baseline to 16 weeks

Central Contacts

Aurinia Clinical Trials Information

CONTACT

833-606-5975 clinicaltrials@auriniapharma.com

Data from ClinicalTrials.gov

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