NCT07256301

A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)

A Multicenter, Open-Label, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Profiles of Multiple Doses of the Humanized Monoclonal Antibody EA5 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Lanyi Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Detailed description

This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The study plans to enroll 24-26 PNH patients. The primary objective is to assess the incidence and severity of adverse events (AEs) from baseline to Week 14.The treatment period is divided into a Loading Phase (Day 1 to Day 14) and a Maintenance Phase (Day 15 to Day 85). During the maintenance phase, patients will be assigned to one of three dose cohorts: Cohort 1/Cohort 1' (900 mg, IV, Q4W), Cohort 2/Cohort 2' (1200 mg, IV, Q4W), and Cohort 3 (1400 mg, IV, Q4W). Cohorts 1-3 are for patients previously naive to complement inhibitor therapy, while Cohorts 1'-2' are for patients recently naive to complement inhibitor therapy.

Conditions

• PNH - Paroxysmal Nocturnal Hemoglobinuria

Interventions

Type	Name	Description
BIOLOGICAL	EA5	All treatments were given as IV infusions.

Timeline

• Start date: 2024-01-03
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

2 sites across 1 country: China