Study of Aritinercept in Patients With Generalized Myasthenia Gravis

Aurinia Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myasthenia Gravis, Generalized

Treatments: Drug: Aritinercept; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07596901

AUR-200-2024-02

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

81 participants in 2 patient groups, including a placebo group

Aritinercept

Experimental group

Description:

Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection

Treatment:

Drug: Aritinercept

Placebo

Placebo Comparator group

Description:

Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection

Treatment:

Other: Placebo

Drug: Aritinercept