NCT07475754

A Study to Evaluate the Safety and Tolerability of Rituxan in Duchenne Muscular Dystrophy

A Single-arm, Non-blind, Single-center Study to Evaluate the Safety and Tolerability of Rituximab Down-regulating Immunoglobulin (Ig) Treatment in Children With Duchenne Muscular Dystrophy (DMD) Who Can Walk

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

1. Study population:It is applicable to male participants with genetically confirmed and clinically confirmed Duchenne muscular dystrophy (DMD), aged between 6 and 10 years. 2. Research period:The main research period of this clinical study is one year. Participants were tested during the baseline period and were followed up on days 0, 7, 14, 21, 60, 120, 200, and 360. 3. Exploratory indicators：MR Of both thighs, quantitatively calculating the muscle fat replacement indicators of the buttocks and proximal thighs；Patient Self-Rating Scale, Caregiver Self-Rating Scale. 4. Safety assessment：The safety assessment population will include all participants who have received the drug dose and have at least one post-drug safety assessment. Adverse events (AE) collected from the participants signed informed consent, all the way to the main study period at the end of the last follow-up. Safety laboratory evaluation, laboratory safety monitoring, including hematology, blood biochemistry, urine analysis (including troponin I, CK and CK - MB) and blood coagulation function, as well as complement. All common medication will be recorded. All adverse events, including abnormal complete blood cell count results, will be continuously tracked until they are resolved or stabilized. Only treatment-related adverse events (TEAE) will be summarized. AEs will be based on MedDRA and organ systems are recorded and archived. The classification and terminology related to AEs will be described according to the version of CTCAE v6.0.

Conditions

• Duchenne Muscular Dystrophy (DMD)

Interventions

Type	Name	Description
DRUG	Rituxan treatment	Rituxan treatment

Timeline

• Start date: 2026-03-23
• Primary completion: 2026-05-30
• Completion: 2027-04-23
• First posted: 2026-03-16
• Last updated: 2026-03-16