NCT07079020Not yet recruiting
Efgartigimod for Consolidation Therapy in gMG
Multicenter Cohort Study on Efgartigimod for Consolidation Therapy After the Acute Exacerbation of Generalized Myasthenia Gravis in Adults
Source: ClinicalTrials.gov · Last updated 22 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to evaluate the efficacy and safety of consolidation therapy with corticosteroids and/or immunosuppressants combined with efgartigimod in patients with generalized myasthenia gravis after the acute exacerbation.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 29 Jun 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Da, Yuwei, M.D.
- Diseases
- Myasthenia gravis
- NCT number
- NCT07079020
What you commit to
- Study type: Observational
- Planned participants: 130
- From 30 Jul 2025 to the primary completion date, 30 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with IVIg, plasma exchange (PE), IV methylprednisolone (IVMP), or immunoadsorption (IA) within 1 month before consolidation baseline.
- Thymectomy within 6 months before exacerbation baseline.
- Use of immunomodulatory monoclonal antibodies or investigational drugs (not listed above) within 3 months before baseline or 5 half-lives (whichever is longer).
Other illness
- Known hypersensitivity to efgartigimod or any FcRn-targeting therapy.
- Clinically significant comorbidities, including severe cardiovascular, hepatic, renal, pulmonary, or hematologic disorders, active malignancy and uncontrolled systemic infections.
- Other autoimmune diseases that may interfere with efficacy assessment (e.g., uncontrolled thyroid disease, severe rheumatoid arthritis).
- Any other condition deemed unsuitable by the investigator.
Other
- Pregnancy or lactation (women of childbearing potential must have negative pregnancy test and use contraception).
Who the study is looking for
- Age ≥18 years, male or female.
- Diagnosis of myasthenia gravis (MG) based on the following:
- Typical clinical features of MG.
- At least one of the following:
- Seropositive for anti-AChR antibodies (confirmed by reliable assay). Abnormal neuromuscular transmission on electrophysiological testing (e.g., RNS or SFEMG).
- Positive neostigmine test or documented response to cholinesterase inhibitors.
- MGFA classification II-IV at consolidation baseline.
- Seropositive for anti-AChR antibodies (required for enrollment).
- Hospitalized for myasthenic crisis (MC) in the acute exacerbation and completed one treatment cycle of efgartigimod: acute exacerbation definition: Presence of MC warning signs (new or worsening within 2 weeks): Bulbar symptoms: Dysphagia, choking, weak cough, dysarthria. Respiratory symptoms: Dyspnea, respiratory muscle weakness. Generalized weakness: Head drop, jaw weakness, facial weakness. One treatment cycle of efgartigimod: 10 mg/kg IV, once weekly for 4 doses.
- ≥2-point improvement in MG-ADL score from acute exacerbation baseline by Day 4 of efgartigimod treatment.
- Willing and able to provide written informed consent before study participation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.