Telitacicept for Children With Ocular Myasthenia Gravis
Tests telitacicept in children with ocular myasthenia gravis, a muscle-weakness condition.
Plain-language title generated from the registry record
Registry title: A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis
Key facts
- Where
- Hangzhou, Jinan, and Shenzhen, ChinaSee the 3 sites
Where in China
- The Children's Hospital, Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Children's Hospital Affiliated to Shandong UniversityJinan, ChinaNo longer taking part
- Shenzhen children's Hospital of China Medical UniversityShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Children's Hospital of Zhejiang University School of Medicine
- Trial code
- NCT07298928
- Record updated
- 6 March 2026
- Original description
Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in national multicenter clinical trials for adult OMG. Our center published a retrospective study in the Chinese Journal of Evidence-Based Pediatrics in August 2025, which was the first report both domestically and internationally on the efficacy and safety of Telitacicept in four pediatric OMG patients. This study plans to conduct a prospective, multicenter, open-label, single-arm clinical trial aimed at evaluating the effectiveness and safety of Telitacicept in pediatric OMG.Read full original descriptionShow less
The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health
Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in national multicenter clinical trials for adult OMG. Our center published a retrospective study in the Chinese Journal of Evidence-Based Pediatrics in August 2025, which was the first report both domestically and internationally on the efficacy and safety of Telitacicept in four pediatric OMG patients. This study plans to conduct a prospective, multicenter, open-label, single-arm clinical trial aimed at evaluating the effectiveness and safety of Telitacicept in pediatric OMG.
Inclusion: The patient and their legal guardian voluntarily sign the informed consent form; Age < 18 years, male or female; Diagnosis of OMG according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition); Stable administration of any one or combination of the following standard treatments prior to enrollment:; Cholinesterase inhibitors; Glucocorticoids.
Exclusion: Participation in any other clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug from the previous trial (whichever is longer); Active infection under treatment： Patients who are HBsAg positive must be excluded. Patients who are HBsAg negative but HBcAb positive must undergo quantitative HBV-DNA testing. Patients with a positive quantitative HBV-DNA result must be excluded; those with a negative result may be enrolled; Severe hepatic or renal insufficiency; Patients with malignant tumors other than thymoma; History of allergy to human-derived biological products; Patients deemed unsuitable for participation by the investigator (e.g., patients with severe psychiatric disorders); Hypogammaglobulinemia (IgG < 400 mg/dL) or IgA deficiency (IgA < 10 mg/dL); Patients within 3 months post-thymectomy.