Study of Aritinercept in Patients With Generalized Myasthenia Gravis
Purpose
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.
Condition
- Myasthenia Gravis, Generalized
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Aritinercept |
Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection |
|
|
Placebo Comparator Placebo |
Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection |
|
Recruiting Locations
Aurinia Investigational Site
Altamonte Springs, Florida 32714
Altamonte Springs, Florida 32714
Aurinia Investigational Site
Boca Raton, Florida 33487
Boca Raton, Florida 33487
Aurinia Investigational Site
Miami, Florida 33173
Miami, Florida 33173
More Details
- Status
- Recruiting
- Sponsor
- Aurinia Pharmaceuticals Inc.