Clinical trial · Interventional
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
NCT07596901CI-TRIAL-00120325recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aritinercept | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aritinercept
- description
- Double-Blind Treatment Period: Aritinercept by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
- interventionNames
- Drug: Aritinercept
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Double-Blind Treatment Period: Placebo by subcutaneous injection Open-Label Treatment Period: Aritinercept by subcutaneous injection
- interventionNames
- Drug: Aritinercept
- Other: Placebo
Primary outcomes (1)
- measure
- To assess the safety and tolerability of aritinercept: Incidence of treatment-emergent adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.