NCT06479863

Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Austin Neuromuscular Center · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Pozelimab/Cemdisiran combination therapy in patients with sIBM

Detailed description

This is a pilot study of 10 patients to receive Pozelimab 200mg/Cemdisiran 200 mg SC injections every 4 weeks for 104 weeks. SC injections will be administered by the study staff and the patient will be monitored for 30 minutes after the initial first injection. During the remainder of the study, injections can be administered at home by the patient or caregiver after injection training provided by the study staff. Designated persons will be observed to confirm their ability to perform the injections. The dosing window of the study treatment is within ±7 days from the scheduled dose date.

Conditions

• Sporadic Inclusion Body Myositis (sIBM)
• Idiopathic Inflammatory Myopathies

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Pozelimab/Cemdisiran	Patients to receive Pozelimab 200mg/Cemdisiran 200 mg SC injections every 4 weeks for 104 weeks

Timeline

• Start date: 2024-08-08
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2024-06-28
• Last updated: 2026-01-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study