NCT06827587Not yet recruiting
Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis
Efficacy, Safety, and PKPD Study of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis (gMG): an Open-label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Title: The Efficacy, Safety, and PK/PD of Efgartigimod Followed by Telitacicept in Generalized Myasthenia Gravis: Protocol of a Randomized Controlled Trial Objective: This study aims to evaluate the efficacy, safety, and pharmacokinetics/pharmacodynamics (PK/PD) of efgartigimod followed by telitacicept in patients with generalized myasthenia gravis (gMG). Specifically, the trial seeks to determine the optimal treatment strategy for gMG by assessing the effect of sequential biologic therapy on disease management. Study Design: This is a multi-center, open-label, randomized controlled trial involving 60 acetylcholine receptor antibody-positive gMG patients.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Myasthenia gravis
- NCT number
- NCT06827587
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Feb 2025 to the primary completion date, Feb 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
- Patients with thymoma who have undergone surgery within the past 6 months.
- Patients who have used biologic agents before enrollment and are within 5 half-lives of the drug, such as those who have used Telitacicept within the past 2 months, Efgartigimod within the past 1 month, or Rituximab within the past 6 months.
- Patients who have received intravenous immunoglobulin (IVIg) or undergone plasmapheresis within the past 2 months before enrollment.
- Patients who have received any live vaccines within 3 months before the study or plan to receive any vaccines during the study.
- Patients who have participated in any clinical trial within the 28 days before enrollment or are within 5 half-lives of the investigational drug used in a prior clinical trial.
Other illness
- Coexisting active autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis, Sjögren's Syndrome, etc.
- Patients with active infections, such as Herpes Zoster, HIV, active Tuberculosis, active Hepatitis.
- Patients with malignancies other than thymoma.
- Patients with allergies to human-derived biologics.
- Other patients deemed unsuitable for enrollment by the investigator (e.g., severe mental disorders).
Lab values
- Patients with severe liver or renal dysfunction, defined as: Liver function: ALT or AST \> 3 ×ULN (upper limit of normal). Renal function: Glomerular filtration rate (GFR) \< 30 mL/min/1.73m².
- IgG ≤ 400 mg/dL.
Other
- Pregnant or breastfeeding women, or those planning to conceive during the trial.
Who the study is looking for
- The patient voluntarily signs the informed consent form.
- Age ≥18 and ≤80 years, regardless of gender.
- Meets the diagnostic criteria for Myasthenia Gravis (MG) as per the 2020 China MG Diagnosis and Treatment Guidelines, with serological evidence of positive AChR-Ab.
- MG Clinical Classification according to the Myasthenia Gravis Foundation of America (MGFA) Staging System: Grade II-IV.
- Patients with fluctuating MG symptoms before enrollment, as indicated by MG-ADL score ≥6 or Quantitative Myasthenia Gravis score (QMG) ≥8, maintained for more than 24 hours.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.