Study of Aritinercept in Patients With Generalized Myasthenia Gravis
A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety and Efficacy of Aritinercept, a Dual BAFF/APRIL Inhibitor, in Patients With Generalized Myasthenia Gravis
1 other identifier
interventional
81
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2026
CompletedFirst Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2029
May 19, 2026
May 1, 2026
2.9 years
May 13, 2026
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Baseline to study completion, up to 73 weeks
Secondary Outcomes (1)
To assess the efficacy of aritinercept: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score
Baseline to 16 weeks
Study Arms (2)
Aritinercept
EXPERIMENTALDouble-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Placebo
PLACEBO COMPARATORDouble-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients (18-85 years old)
- Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
You may not qualify if:
- Current or medical history of malignancy within the last 5 years
- Pregnant, breastfeeding or intending to become pregnant during the Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Aurinia Investigational Site
Altamonte Springs, Florida, 32714, United States
Aurinia Investigational Site
Boca Raton, Florida, 33487, United States
Aurinia Investigational Site
Miami, Florida, 33173, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
May 19, 2026
Study Start
April 22, 2026
Primary Completion (Estimated)
March 2, 2029
Study Completion (Estimated)
March 2, 2029
Last Updated
May 19, 2026
Record last verified: 2026-05