Study of Aritinercept in Patients With Generalized Myasthenia Gravis

Part of paid clinical trials in Altamonte Springs, Florida.

Sponsor
Aurinia Pharmaceuticals Inc.
Study ID
NCT07596901
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Aritinercept — DRUG
    For subcutaneous injection
  • Placebo — OTHER
    For subcutaneous injection

Study Details

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.

Key Dates

Start date
Apr 22, 2026
Status verified
May 2026
Primary completion
Mar 2, 2029
Completion
Mar 2, 2029

Study Design

Enrollment
81 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events [ Time Frame: Baseline to study completion, up to 73 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Aurinia Investigational SiteAltamonte SpringsFlorida32714
Aurinia Clinical Trials Information
[email protected]
833-606-5975
Aurinia Investigational SiteBoca RatonFlorida33487
Aurinia Clinical Trials Information
[email protected]
833-606-5975
Aurinia Investigational SiteMiamiFlorida33173
Aurinia Clinical Trials Information
[email protected]
833-606-5975

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By research site
Aurinia Investigational Site· Altamonte Springs, FLAurinia Investigational Site· Boca Raton, FLAurinia Investigational Site· Miami, FL

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