Study of Aritinercept in Patients With Generalized Myasthenia Gravis
ConditionMyasthenia Gravis, Generalized
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAurinia Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18-85 years old)
Myasthenia Gravis Foundation of America (MGFA) Class II-IV gMG
Additional inclusion criteria are defined in the protocol
Disqualifiers
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
Design model
Sequential
Treatments tested in this trial
Aritinercept
DrugFor subcutaneous injection
Placebo
Other interventionFor subcutaneous injection
Treatment groups
81 Participants
are divided into 2 treatment groupsGroup A: AritinerceptExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Time frame
Baseline to study completion, up to 73 weeksSecondary outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov