NCT04060264

Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria

Randomized, Open-Label, International, Multi-center, Comparative Study of Efficacy and Safety of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Patients With Paroxysmal Nocturnal Hemoglobinuria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a randomized, open-label, international, multi-center, comparative study of efficacy and safety of BCD-148 and Soliris® in PNH patients. It is planned to investigate the efficacy, safety, and immunogenicity of one-year eculizumab course in this study. PNH - Paroxysmal nocturnal hemoglobinuria

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
BIOLOGICAL	BCD-148	Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5. Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period). QW - once weekly
BIOLOGICAL	Soliris	Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5. Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).

Timeline

• Start date: 2019-04-04
• Primary completion: 2020-04-27
• Completion: 2020-12-30
• First posted: 2019-08-19
• Last updated: 2021-02-12

Locations

1 site across 1 country: Russia