NCT07298928Not yet recruiting

A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis

The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 9 Dec 2025
Start date: 10 Mar 2026
Primary completion date: 31 Dec 2028
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Diseases: Myasthenia gravis
NCT number: NCT07298928

What you commit to

Study type: Interventional
Planned participants: 30
From 10 Mar 2026 to the primary completion date, 31 Dec 2028
3 sites in 1 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

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).

Other illness

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).

Lab values

Hypogammaglobulinemia (IgG \< 400 mg/dL) or IgA deficiency (IgA \< 10 mg/dL).

Other

Patients within 3 months post-thymectomy.

Who the study is looking for

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

Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The Children's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status	Hangzhou	China	Unknown status
Children's Hospital Affiliated to Shandong University Coordinator of this site? Confirm its status	Jinan	China	Unknown status
Shenzhen children's Hospital of China Medical University Coordinator of this site? Confirm its status	Shenzhen	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.