Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients.

NCT ID: NCT07212426

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2028-03-31

Brief Summary

This is a multicenter, randomized, open-label, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Conditions

PNH - Paroxysmal Nocturnal Hemoglobinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LP-005 900 mg

Patients will receive intravenous infusion of LP-005 Injection at a dose of 900 mg once every 4 weeks.

Group Type: EXPERIMENTAL

LP-005 Injection

Intervention Type: BIOLOGICAL

IV infusion, Q4W

LP-005 1200 mg

Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks.

Group Type: EXPERIMENTAL

LP-005 Injection

Intervention Type: BIOLOGICAL

IV infusion, Q4W

LP-005 1500 mg

Patients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks.

Group Type: EXPERIMENTAL

LP-005 Injection

Intervention Type: BIOLOGICAL

IV infusion, Q4W

Interventions

LP-005 Injection

IV infusion, Q4W

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female, aged 18 to 65 years.
• Diagnosis of PNH based on flow cytometry with clone size > 10% by granulocytes.
• Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH.
• LDH level ≥2.0×upper limit of the normal range(ULN).
• Hemoglobin level <100 g/L at screening.

Exclusion Criteria

• Active or suspected active viral, bacterial, fungal, or parasitic infection within 14 days prior to screening.
• History of meningococcal infection.
• History of splenectomy or congenital asplenia.
• History of systemic autoimmune disease or known/suspected immunodeficiency.
• History of hematopoietic stem cell transplantation.
• Use of any complement inhibitor within 3 months prior to screening or within 5 drug half-lives (whichever is longer).
• Pregnant or breastfeeding women, or women planning to become pregnant during the study or follow-up period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Longbio Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guangsheng He

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Countries

China

Other Identifiers

P10-LP005-02

Identifier Type: -

Identifier Source: org_study_id